Podcast appearances and mentions of stephanie vaughan

Learn how to master your mindset, embrace discomfort and turn challenges into opportunities. Today, we're talking about a key but often overlooked part of success—mindset. The most successful entrepreneurs credit their resilience, adaptability, and ability to embrace discomfort as the real game-changers. In this episode, we'll break down what it takes to build a strong mindset, manage stress, and create habits that set you up for long-term success. Joining me today are Stephanie Vaughan and Tom Trush, experts in business growth. Stephanie has helped companies generate over $100 million in revenue, coaching leaders and streamlining systems. Tom, a marketing strategist and author of Escape the Expected, has spent nearly 20 years helping businesses sharpen their messaging and grow. Together, they'll share insights on mindset, resilience, and success. In this episode, you'll learn: How mindset shapes success and decision-making. Why energy management is key to business growth. The connection between physical health and mental sharpness. How discomfort builds confidence and problem-solving skills. The importance of recognizing and celebrating progress. Why delegating tasks and decisions boosts efficiency. How reframing setbacks can open new doors. All this and more, on this week's episode of Beyond 7 Figures. Don't forget to subscribe to the show to get that episode as soon it gets released. Until then, be profitable. Links: **https://predictableprofits.com/** https://www.youtube.com/@PredictableProfits https://www.facebook.com/PredictableProfits https://www.linkedin.com/company/predictable-profits/

The Tampa Bay area law school that graduated incoming President Trump's nominee for Attorney General is looking forward to a bump in prestige pending her confirmation. We speak with Stephanie Vaughan, Stetson College of Law alumna and law professor, about another Stetson Law alum, former Florida Attorney General Pam Bondi., who appears before the U.S. Senate Judiciary Committee Wednesday (15th)  (Photo Credit: Getty Images/Canva)

Learn how to delegate, empower your team, and build a self-sustaining business. This episode covers the essential strategies for scaling your business beyond seven figures without becoming its main bottleneck. We'll discuss how to delegate effectively, foster a culture of trust, and implement systems that enable your company to thrive without your constant oversight. If you're looking to empower your team, step back from daily operations nd let your business grow independently, this episode is for you. Joining us today are two key figures from Predictable Profits, Stephanie Vaughan and Joe Beecroft. Stephanie, a co-founder of Predictable Profits, is a global business coach and systems expert, formerly leading coaching for Tony Robbins and Chet Holmes' Business Breakthroughs International. Joe Beecroft, the chief of staff, specializes in helping CEOs and business owners overcome scaling challenges, making him a vital resource for growth-focused leaders. Key take aways this episode: Empowering your team is crucial for business growth, allowing you to step away without operations falling apart.  Delegation is most effective when you choose the right people for the task and provide clear instructions.  Building a culture of trust and accountability ensures that your team can make decisions and solve problems independently.  Documenting systems and processes is essential for creating a business that can run without you.  To create a business with maximum valuation, the company must not be dependent on any single leader, including the CEO.  All this and more, on this week's episode of Beyond 7 Figures.

Learn how to create a self-sustaining business through strategic leadership In this episode, we talked about the essential strategies for building a business that operates independently of its CEO. We explore effective delegation, empowering your team, and implementing systems that ensure continuity and innovation, even in the CEO's absence. Whether you aim to take a much-needed vacation or reduce your day-to-day involvement in the business, this episode provides actionable advice for achieving sustainable success and greater personal freedom. Joining us are Joe Beecroft and Stephanie Vaughn, two pivotal members of Predictable Profits. Joe, the Chief of Staff, ensures smooth operations, while Stephanie, a co-founder and Head of Coaching, guides entrepreneurs to success. Their combined efforts drive the company's growth and efficiency, making them a powerhouse duo in the business world. Listen in as they share their expertise and insights on creating a thriving, self-sufficient business. In this episode you will: Learn how to empower your team to take the reins while you're away. Understand the crucial elements of effective delegation and why it's essential for scaling your business. Find out how CEOs can take a break without disrupting their companies. Understand deeper on the foundations of building a resilient, self-sufficient business. Listen to insights on common pitfalls CEOs face when trying to handle everything themselves. Reevaluate your leadership approach by leveraging your team's strengths. Learn about creating systems that allow your business to thrive independently. Consider new perspectives on how trust and empowerment can reshape your company's culture. All this and more, on this week's episode of Beyond 7 Figures. Stay tuned next week. So, don't forget to subscribe to the show to get that episode as soon it gets released. Until then, be profitable. Links: beyond7figures.com https://podcasts.apple.com/au/podcast/beyond-7-figures-build-scale-profit/id1476094077 https://open.spotify.com/show/311dTeS0doORrhHZUgwxfN https://predictableprofits.com/beyond-7-figures/

In this episode, Alay and Stephanie discuss:  How a virtual answering service can help your law firm. Building a customer … Virtual Reception with Stephanie Vaughan Jones Read More »

Ready for another way to be the Exhibit (A)ttorney of your law firm? Today Jordan is chatting with Stephanie Vaughan-Jones, from Moneypenny. Don't miss our awesome conversation!

It's your favorite STEM podcast, Don't Be Scared! Where we learn more about the real people who make up STEM.I'm your host, Dr. J. I'm here to give you a little insight into the exciting world of STEM careers.On today's episode, we talk with Dr. Stephanie Vaughan, who is a postdoctoral researcher in the Naval Research Laboratory and a true inspiration to women in science. We got a chance to talk about her postdoc position and her background story. We talked about her experience as being a black woman in a primarily white male field. She gives some great advice for women seeking careers in this field.If you enjoy listening to the podcast and get something out of it, share it with a friend!To learn more about Don't Be Scared click the link below.https://linktr.ee/dontbescaredok

Ep #100 - It's the 100th episode of the Beyond 7 Figures podcast, and I'm celebrating the journey by bringing my Predictable Profits business partners, Stephanie Vaughan and Zach Burkes, onto the show to discuss the power and importance of business partnerships.  Learn More About Predictable Profits: Visit the Predictable Profits website at: https://predictableprofits.com/ Also, please remember to subscribe, rate, and leave a written review for the show if you find value in it. Your reviews help this show to reach a wider audience and I appreciate everyone that has been leaving them.   FOLLOW CHARLES GAUDET ON SOCIAL MEDIA: Follow Charles Gaudet on LinkedIn: https://linkedin.com/in/charlesgaudet Follow Charles Gaudet on Facebook: https://facebook.com/charlesgaudet Follow Charles Gaudet on Twitter: https://twitter.com/charlesgaudet   VISIT THE PREDICTABLE PROFITS WEBSITE: https://PredictableProfits.com

Purchase your copy of 'Half Him Half Her' on Amazon here.To reach out to Steph on facebook, click here. 

You trust your bank to be private, accurate and secure. So how is Blockchain technology the next evolution in trust, privacy, accuracy and security? Stephanie Vaughan, VP Corporate Development at Equa, stepped into the VeteranCrowd Spotlight to tell us how.  A 2007 graduate of the US Naval Academy at Annapolis, she commissioned into the Marine Corps. After five years of active duty, she earned her MBA at Columbia and entered investment banking. Her career path includes venture debt, venture lending, and now blockchain technology.  Blockchain and digital currencies continue to evolve. But blockchain applications are not limited to digital currency like Bitcoin. Equa is developing blockchain applications for the tokenization and digital forms of securities. So imagine a new way to compensate employees with stock, only digital. This technology allows even small business to have an efficient, verifiable, secure means of issuing incentives.  And blockchain does not stop there - Equa will be applying it to a wide variety of applications where accuracy and security are required. But enough about that.  Stephanie also shares her thoughts on military business leaders, and we discussed the evolving role  and acceptance of women at the Academies and on active duty.  About our guest You can learn more about Stephanie Vaughan on LinkedIn or Follow her on Twitter And learn more about Equa https://www.equa.global/ About your host Bob Louthan is a VMI Graduate, Army veteran, and executive with over 25 years of experience in mergers, acquisitions and private capital formation. He founded the VeteranCrowd Network to bring veterans and veteran-led businesses together with each other and the resources they need to prosper. You can learn more about Bob Louthan on LinkedIn.

Is it frivolous to care about your appearance or is it good self care? Can we be fashionable and sustainable? Listen and discover.

In this episode we compile backstage interviews from our second TF Blockchain Conference back on November 9, 2018. You'll hear from: Amy Karr - CEO and Founder Galileo Paul Gambill - CEO & CoFounder at Nori Alexsandra Guerra - CoFounder & Director of Corporate Development at Nori Sam O. Yilmaz - Investor Rui Maximo - CTO at Concreit Stephanie Vaughan - CFO at Elixxir

Dr. Mitch Goldstein explains what NEC is, who it typically affects, its symptoms, and treatment. He also discusses what parents should ask about their baby's nutrition in the NICU. Kelli then speaks to Stephanie Vaughan whose son contracted NEC while in the NICU. Stephanie speaks about his journey back to health and how she eventually started The Morgan Leary Vaughan Fund to educate other parents about NEC.

Dr. Mitch Goldstein explains what NEC is, who it typically affects, its symptoms, and treatment. He also discusses what parents should ask about their baby's nutrition in the NICU. Kelli then speaks to Stephanie Vaughan whose son contracted NEC while in the NICU. Stephanie speaks about his journey back to health and how she eventually started The Morgan Leary Vaughan Fund to educate other parents about NEC.

Top(ic) of the morning: Dealing with the Pain of Discipline or Regret. In this special broadcast, Gibbons and Gould speak with business entrepreneurs on how Hurricane Irma affected them and their businesses. G SPOT guest Stephanie Vaughan says, "You do YOU." Jesse in Wichita, Stephanie from Fort Worth and Renee from Lincoln get help in Fix It In 5. Quit Qommentary by GIBBONS. This show is broadcast live on Wednesday's at 7:00AM ET on W4CY Radio – (www.w4cy.com) part of Talk 4 Radio (http://www.talk4radio.com/) on the Talk 4 Media Network (http://www.talk4media.com/).

Stephanie Vaughan joins Ted Miller III as they both share insights on what it takes to show up and sell, grow, and excel. Bottomline, if you are a "good" person, expect poor results. How you step into your life, work, relationships shows up in your results. If you don't like your results, you then need to raise your standards. Learn how to participate in creating an outstanding life and business and don't settle for less. [audio mp3="https://tedmiller3.com/wp-content/uploads/2017/04/The-Road-to-Selling.mp3"][/audio]

History is made and a new entrepreneurial chapter is opened in Ep. 233 – Ted Miller III joins the team to celebrate the launch of G Team Radio's new supercharged online coaching program for entrepreneurs, QAGR QOACHING. The G SPOT makes its debut with thoughts from female entrepreneurs with attitude and something to say that you will want to hear – kicking off with Stephanie Vaughan founder of One Source Coaching. All this plus Top(ic) of the Morning, Hypergrowth Daily and Fix It In 5.This show is broadcast live on Wednesday's at 7:00AM ET on W4CY Radio – (www.w4cy.com) part of Talk 4 Radio (http://www.talk4radio.com/) on the Talk 4 Media Network (http://www.talk4media.com/).

In Episode 12, Stephanie Vaughan, Co-founder and President of The Morgan Leary Vaughan Fund, goes from Speaking of NEC: Necrotizing Enterocolitis host to guest as media broadcaster Jeff Bradbury turns the microphone on her for a retrospective. Stephanie reflects on the podcast series itself, and her experiences as a mother-turned-prematurity-and-rare-disease-advocate-turned-podcaster. She also looks towards the future for The Morgan Leary Vaughan Fund. Copyright © 2016 The Morgan Leary Vaughan Fund, Inc. This episode was produced in part by the TeacherCast Educational Broadcasting Network. [powerpress] Copyright © 2016 The Morgan Leary Vaughan Fund, Inc. The opinions expressed in Speaking of NEC: Necrotizing Enterocolitis (the Podcast series) and by The Morgan Leary Vaughan Fund are published for educational and informational purposes only, and are not intended as a diagnosis, treatment or as a substitute for professional medical advice, diagnosis and treatment. Please consult a local physician or other health care professional for your specific health care and/or medical needs or concerns. The Podcast series does not endorse or recommend any commercial products, medical treatments, pharmaceuticals, brand names, processes, or services, or the use of any trade, firm, or corporation name is for the information and education of the viewing public, and the mention of any of the above on the Site does not constitute an endorsement, recommendation, or favoring by The Morgan Leary Vaughan Fund.

Dr. Sheila Gephart. Photo courtesy of Dr. Sheila Gephart. Episode 8 features Dr. Sheila Gephart, neonatal nurse scientist and assistant professor at the University of Arizona College of Nursing. During this episode, Dr. Gephart provides a comprehensive overview of GutCheckNEC, a first-of-its-kind, 10-item risk assessment that she developed for the early detection of NEC in premature infants. She discusses: * Her transition from bedside nurse in the neonatal intensive care unit to her development of GutCheckNEC—what she calls a “real-time, early warning score for NEC,”* The 10 risk factors that make up GutCheckNEC, their associated symptoms, and how risk is communicated,* The development of NEC Zero, an intervention that has evolved out of the Unit NEC rate component of GutCheckNEC,* The strength of evidence for the use of probiotics in the prevention of NEC, and* The importance of shared decision making in the NICU. Copyright © 2015 The Morgan Leary Vaughan Fund, Inc. This episode was produced in part by the TeacherCast Educational Broadcasting Network. [powerpress] STEPHANIE VAUGHAN, HOST: Welcome to Episode 8 of Speaking of NEC—a free, audio podcast series about Necrotizing Enterocolitis. Produced by The Morgan Leary Vaughan Fund, and funded by The Petit Family Foundation, Speaking of NEC is a series of one-on-one conversations with relevant NEC experts—neonatologists, clinicians and researchers—that highlights current prevention, diagnosis, and treatment strategies for NEC, and the search for a cure. For more information about this podcast series or The Morgan Leary Vaughan Fund, visit our website at morgansfund.org. Hello, my name is Stephanie Vaughan. Welcome to the show. I’m the Co-founder and President of The Morgan Leary Vaughan Fund. Today, my guest will be Dr. Sheila Gephart, neonatal nurse scientist and assistant professor at the University of Arizona College of Nursing, who developed a first-of-its-kind, 10-item risk assessment for the early detection of NEC in premature infants called GutCheckNEC. During our conversation, she will discuss in varying degrees: Her transition from bedside nurse in the neonatal intensive care unit to her development of GutCheckNEC—what she calls a “real-time, early warning score for NEC,” The 10 risk factors that make up the acronym GutCheck and their associated symptoms How risk is communicated, The significance of the Unit NEC rate component in GutCheckNEC, and how that led her to develop the NEC Zero Intervention, The strength of evidence for the use of probiotics in the prevention of NEC, and The importance of shared decision making in the NICU. With that in mind, let me introduce my guest today. Hi, welcome to the show. This is my guest, Dr. Sheila Gephart. She is a neonatal nurse scientist from the University of Arizona College of Nursing. Hi, Sheila, how are you? DR. SHEILA GEPHART, GUEST: Good, thank you, Stephanie! STEPHANIE: Thank you! So, we have had more than one person mention you on our show in previous episodes, so I’m thrilled to have you join me today and would love to let you talk a little bit about your background and how you got involved with Necrotizing Enterocolitis. DR. GEPHART: Well, I am very thankful to be asked to be on the broadcast today, and I will tell you that I started my interest in Necrotizing Enterocolitis risk understanding when I was a bedside nurse. I have been a nurse since 1997, and I worked in the neonatal intensive care unit as a bedside nurse taking care of babies, and many of them were really convalescing. They were doing well, but then we had a subset of babies, or a clump of babies, that all developed this horrible disease within about three weeks. And now I know the clustering of NEC is very common, or not common, but it does happen. STEPHANIE: Right. DR. GEPHART: But then I didn’t really understand a whole lot about the disease, but I was very concerned because I realized that we had been concerned about these babies, as nurses, for hours to days before the actual diagnosis of NEC was made. So what happened at that point was I had the role of getting into the data for our NICU. I collected the data and reported the data for a large registry called the Vermont Oxford Network. And so I was focused on looking at the baby’s case and looking at the research and looking at the data, and I realized that there was a constellation of risk factors that kind of coalesced for these kids, that all of these things seemed to snowball with these babies who developed NEC, and we really had no context for talking to physicians to communicate why we were concerned. We were using terms like something’s not right with this baby, and from there, it really launched me into the next five years of understanding more about NEC risk. STEPHANIE: Okay. And can you talk to me a little bit about the protocol – I think it’s a protocol -- that you’ve developed called GutCheckNEC and how you got from starting to look at the data to compiling and understanding this set of risk factors? DR. GEPHART: Sure, I’m happy to talk about GutCheckNEC. So, being a bedside nurse, sometimes I would work in the middle of the night, and I needed a strategy for putting things together so I could remember them. And when I thought about NEC, I thought about well, we just need to check the gut. So GutCheck was kind of how it organized these risk factors, and I wrote GutCheck in a line straight down, and I remember one day I was at a delivery, and it was about three in the morning and it was taking a while for the baby to be born. And I was trying to understand all of the research that I had been reading about NEC risk and so what I did was I write GutCheck straight down on a napkin and horizontally for each letter I wrote the risk factor that was associated with that letter, and so that helped me organize what I was reading in the literature. But really it started out as just wanting to develop a risk assessment so nurses could really know what the risk factors were, physicians could know what the risk factors were, but then also put the symptoms in the context of what was going on with the baby. So that’s where I started, but then I went into a Ph.D. program, and in science you have to be very systematic. And so my literature review was the systematic beginning. But then what I did was I asked neonatal NEC experts how relevant they thought the different risk factors were to actually developing NEC. So I asked them to rate the relevance, and we went through three rounds of surveys to determine if we had the right list of risk factors, so that was very useful. We got rid of some, we kept most of them and added a few. And then, the next step was I got a very large dataset from a group of neonatal practices here in the US called The Pediatrics Medical Group, and I built, this is research speak, but I will tell you that I threw all of the risk factors into a statistical model to see what fell out as the most important, and the way statistical models work is that they keep the most important things that account for most of the explanation for what you’re looking at, and they get rid of everything that’s not quite so important. STEPHANIE: Okay. DR. GEPHART: So we went from like 33 risk factors down to essentially ten risk factors for GutCheckNEC. And then we tested it to see if it actually discriminated or told the difference between the kids that got NEC and the ones who didn’t, and it showed pretty good discrimination, or separation of groups, for the kids who had the most severe NEC compared to those who didn’t get NEC at all. STEPHANIE: Okay. DR. GEPHART: So that was the work we did, and now we’re taking this ten item tool and we’re trying to combine it with clinical science so that we can really have a real time early warning score for NEC. STEPHANIE: Great. Can you sort of go down the list just for parents that might be listening or family members if they’re seeing any of these risk factors? DR. GEPHART: Sure, I’d be happy to do that. The items that we kept in GutCheckNEC, like I said, there are two versions. There’s the one before the statistical modeling and then there is the one after, and the one that’s before is actually more comprehensive. And if you think about just writing GutCheck down linearly, you think for G, you’ve got growth restricted, so they’re born really small for gestational age, you’ve got gestational age. Those are the main ones that I always thought of with the G. And then with U, the one item that the experts recommended adding was the unit NEC rate, because infants who are in units with high NEC rates are more likely to get NEC, and so I didn’t understand that finding. I’ll talk about that in a minute, about the unit NEC rate. T, if you talk about T, transfusion. There is an association that we see in lots of studies with transfusion and NEC. We don’t see any evidence of causation, but the studies aren’t designed to show us that, so there is a temporal relationship or a time based relationship between transfusion and the most severe NEC. That said, there is a lot of babies who get transfusions and don’t get NEC. So that’s what makes it hard. STEPHANIE: Right. DR. GEPHART: What else goes with T? I’m going to stick to the final version, okay, as we think through the acronym. And then for C, signs of infection, so chorioamnionitis is when mom has a really bad uterine infection prior to the baby being born. Some preterm moms have this because—we don’t know exactly why they have this, but chorioamnionitis, particularly if it’s invasive, if it’s really severe, that is a risk factor. Also cardiac kids are going to be more at risk, so if you think of the C, kids who have had heart disease or heart malformations, particularly those that are low oxygenation kinds of defects… STEPHANIE: Right. DR. GEPHART: ..and there are some more for C but I don’t recall exactly what those were right now, but I’m just going to stick—oh, culture proven infection. That also goes with C. So if babies have had sepsis, particularly more than once, which sometimes these really early babies do get multiple bouts of infection, that is a risk factor. So that stayed in my model long term. Enteral feeding is definitely a risk factor that all babies are hopefully exposed to because we want them to be fed. That I understand a lot more now about the details of enteral feeding, and that particularly if the enteral feeding is formula, that is very important. We know formula is a high risk factor. There is a whole slew of argument about cow’s milk based fortifiers that go with that as well, so there is some argument about how extensive of a risk factor that is, but formula and enteral feedings certainly. And then the H, I skipped the H. That would be hypotension treated with medicines to bring that blood pressure up. So hypotension is low blood pressure. A lot of preemies have episodes of low blood pressure, but we know that the most sick are going to be hemodynamically unstable which means that their ability to regulate their blood pressure and keep their heart rate within a good level is not quite as solid as a kid who doesn’t have those light fluctuations, so that was a risk factor that did stay. Also race. Race stayed. The experts did not think that race was a risk factor, and they were pretty, if you remember the stages that we used to develop GutCheckNEC, we asked experts about how relevant they thought these risk factors were and they really didn’t think race was relevant. But it was so strong in the model, I couldn’t get rid of it. So if a baby is either black or Hispanic, that puts them at higher risk. Now, the reason for that we think, we don’t really know exactly why that stayed in the model, however, we know that black babies are very much less likely to get human milk… STEPHANIE: Okay. DR. GEPHART: ..than white babies, and that is something we can fix. So that’s really important. As I went through these risk factors that are in GutCheckNEC, I started to separate in my mind what’s modifiable, which is what of these can we do something about and what is non-modifiable? And what I saw really was quite a few of these things were modifiable that stayed in GutCheckNEC. You can do a query online for GutCheckNEC and it will pop up the actual, you’ll be able to find GutCheckNEC in the literature. It’s published so anybody can find it. But the thing that was so interesting to me, and I’m probably going to go off a little bit here, is that the NICU NEC rate consumed a huge amount of the variants in this tool which means that if we were to say that these items explained an infant’s risk for NEC. The NICU NEC rate explains three times as much as gestational age, three times as much as transfusion. So it was so important, and what we saw in the sample, we had 284 NICUs in the sample that we used to build GutCheckNEC and to verify it, of those 284 NICUs, we saw huge variance in NEC rates. So that was pretty concerning, and it wasn’t something that I went into the research expecting or looking for really even because I had read 70 papers about NEC risk, and invariably, they would start with Necrotizing Enterocolitis is a disease that we have very few answers for. We don’t really know why it occurs, but we know that premature babies are at risk and that is the most consistent risk factor across studies. So prematurity. STEPHANIE: Right. DR. GEPHART: Everybody blamed it on prematurity and low birth rate, and very few said anything about—oh, and we know, actually we have about six large studies from 20 years ago that show that unit NEC rate is consistently an issue. So that is something that I didn’t expect to find, but I found, and then I was able to go back into the literature and find other studies that verified it. STEPHANIE: Excellent. That’s a phenomenal amount of information, and I think that’s really great for parents going into the NICU to have in their minds. DR. GEPHART: And I think, I apologize to the parents for throwing out all these terms, but I know that you’re smart, and you can handle it. Okay, I’m just going to give you credit, because if you’re NICU parents, you’re super savvy, and you know how to find information. STEPHANIE: Right. DR. GEPHART: But one of the things we were really concerned about with NEC is how we communicate risk to parents and how parents are really the eyes and ears of understanding what’s going on with that baby just like the nurses are. STEPHANIE: Right. DR. GEPHART: And they are really better situated, honestly, to be able to identify the trends in their own kid, because that’s all they’re worried about. STEPHANIE: Right. DR. GEPHART: They’re not worried about the delivery down the hallway or all these other things, they are the expert. So one thing I’ve been working on trying to frame this message for parents as partners on the team looking for signs of any kind of complication and I think if they know to speak up. To keep track and to speak up if things don’t seem right, and I’ve heard many physicians actually say that it’s the parents indication of concern that will make them stop, and think slower, about what’s going on with that baby. So either the nurses concern or the parents concern, because often the physician, as excellent as they are, may not be right at that bedside… STEPHANIE: Right. DR. GEPHART: ..at that moment when something is changing. STEPHANIE: Right. Right And we did have an experience between Morgan’s surgeries where there was a concern in the NICU, and I can’t even remember who had mentioned it at rounds of attempting to give him—I don’t know if it was formula or breast milk—but giving him something that the surgeon had previously not agreed to—and it was a whole day of me trying to get in contact with the surgeon and making sure that nobody did anything until the surgeon had said yes or no. And he called me back from outside of the surgical room and said if anything like this happens, call me, I will call you back. So we definitely found that the doctors are very receptive, and especially when you raise an alarm, and to give people concrete things to look at for their babies I think is a wonderful tool. So thank you for sharing this. DR. GEPHART: Absolutely! And I can say that within the next few weeks, probably by the time this podcast is released, our website will be active, and on that website are parent materials that we’ve created that are designed to help them. Anyone can download these parent materials, they can use them in their NICU, and they are basically pamphlets to talk about things to watch for, what you can do to prevent NEC, and what the signs are, and a little bit about what happens afterwards. Because you know the first-hand experience of how different your life is… STEPHANIE: Right. DR. GEPHART: ..coordinating care for a child who’s had NEC. STEPHANIE: Right. DR. GEPHART: So the long term impacts of dealing with life after NEC, I know Laura Martin was on the broadcast… STEPHANIE: Yes. DR. GEPHART: ..recently… STEPHANIE: Yes. DR. GEPHART: ..and her story has been such an important part of my development as a nurse scientist. Think beyond just the NICU stay, to think about how NEC impacts these kids forever. STEPHANIE: Right, right, and we’ve been very lucky that Morgan has had (knock on wood) minimal residual effects. We see a little bit, but I mean, I looked at Laura’s story and they are doing a phenomenal job with him. He is a miracle. DR. GEPHART: Yeah, Joseph is pretty awesome. I haven’t had the chance to meet him in person yet, but Laura and I collaborated to write up his story, and that paper is going to be coming out in the next couple weeks in Journal of Perinatal and Neonatal Nursing, and it is a testament to his resilience. STEPHANIE: Right. Hers too and her husband’s and the family’s. DR. GEPHART: It’s pretty awesome. STEPHANIE: Definitely send me those links and we can certainly share that with everyone—direct links in the show episode notes. So I’ll ask you, now that GutCheckNEC is I’ll say standardized if that’s a correct term, is there anything that you’re looking towards in your research moving forward from GutCheckNEC? DR. GEPHART: Well, that’s a great question, and GutCheckNEC is a risk assessment, it’s a tool. It fits on one page. We’ve just gone through a process where we’ve added to it a structured communication protocol, so if a NICU wanted to use GutCheckNEC, we would have them complete a request form, and on one side is GutCheckNEC, and on the other side is the structured communication form, which also clues the nurses, the parents for which signs and symptoms to look for and how to communicate it. So that’s easy. So that’s where GutCheckNEC is going. We’re also trying to combine it with clinical science right now, so that’s the analysis I’m working on right now, and I’ve worked with a great collaborator, Sherry Fleiner from the Inner Health to do that work. But beyond that, one of the things with research, you do a project and then you have these findings and then there is something that just kind of nabs at you and it doesn’t fit like you expected it to. And for us, that was the unit NEC rate component of GutCheckNEC that carried so much weight in the score, and it demonstrated across the 284 NICUs how variable NEC rates can be. So what we did next is we asked the question, well, why are they different? Why are the NEC rates different? And what if we did something to try to standardize prevention care? So there are a couple of main things that prevent NEC. One is human milk—very, very important starting with colostrum for oral care. The other thing is standardized feeding protocols, stewarding antibiotics, and I can kind of get into more detail there, and then there is a lot of controversy about transfusions. STEPHANIE: Right. DR. GEPHART: So those components, those four things plus a strategy for early recognition, we’ve put those components into an intervention we call NEC Zero, and the name of it is designed to convey that we’re hoping to get NEC to zero rate. Now, this is an audacious goal. But why set goals if they’re not crazy? This is an audacious goal, but it was not my idea. There was an editor for Journal of Perinatology, his name is Jonathan Swanson, and he wrote a paper the year that I finished my dissertation, so I think that was in 2012, it might have been 2013, and the title of that paper was “Can We Get NEC to Zero”? And if you ask scientists this and clinicians this, you will hear a lot of concern that this is an audacious goal. Like of course, we’re not going to get NEC to zero, we don’t even know what causes it. However, we do know some things that consistently reduce the risk for NEC. So human milk is, like I said, those five components, but human milk is so primary. So now we’re trying to put those interventions together, make them implementable so that people in the NICU in Delaware could implement them with the same consistency and clarity that people in Texas could do. STEPHANIE: Right. DR. GEPHART: So that bundle of practices is NEC Zero. So the process for NEC Zero right now where we’re at in the project is that we’ve gone through kind of an expert process of refining the recommendations. So we’ve gone through that, we need to publish that, but we’ve got them. We had a really great expert group of almost 20 people, and four of those people were parents. Laura Martin was on that group. So we’ve got the recommendations, now we’re trying to break those recommendations into implementable steps, and we’re creating tool kit products to go with the NEC Zero intervention. So pieces of that are— GutCheckNEC is definitely a primary component of that. Frankly, GutCheckNEC has the least strong evidence of any of the components in the tool kit. But it’s something that is actionable, it’s something that we can use to monitor, and we know that monitoring and evaluation is a key component of implementation success for anything. So that’s where we’re at right now is we’re working on NEC Zero. STEPHANIE: Great, that sounds excellent. Do you have a projection of when people might see this? You said you’re looking to get it published, or the first stages of it getting published? DR. GEPHART: Right. We’re working on refining the recommendations really in terms of publishing any sort of a recommendation list or a guideline. They carry much more weight if you have the authority of a professional organization behind them. So our strategy right now is to try to link up with some professional organizations and see if we can get some endorsements for them. So if any of your listeners are prominent members of the American Academy of Pediatrics, the National Association of Neonatal Nursing, The Academy for Breastfeeding Medicine—any of those groups would be excellent proponents. So we have the recommendations, we have some parent products that will be available, like I said, within a few weeks once our website gets done, and the other pieces of it being available, I will say that we’re testing it right now. So with the testing, there are two things we’re doing. We have the recommendations, we’re asking experts to kind of assign relative importance to the different parts of the intervention, and that score, we’re creating a ten point score for the NEC Zero adherence score, and that’s almost done. And then we’re going to look at relationships between adoption of NEC Zero practices and NEC rates, because we really don’t have a great evidence body for understanding why NEC rates differ so much NICU to NICU. STEPHANIE: Right. DR. GEPHART: So this is kind of an effort to add to that body of evidence of understanding why are they different. We don’t know what we’ll find, that’s the beauty of research is you start with a hypothesis, you get your data, you test your hypothesis, and you see how it turns out. STEPHANIE: Excellent. This is great work, Sheila. I mean, it sounds like it’s really sort of simple, but I’m sure it’s not. DR. GEPHART: That’s right! It does kind of sound simple, doesn’t it? STEPHANIE: Or that it maybe should be simple. Hopefully it will be simple, but it sounds like parents in the NICU could really take this information and be able to be confident in their monitoring of their children and really confident in voicing any concerns that they see. DR. GEPHART: Right. STEPHANIE: So I think it’s great. DR. GEPHART: The challenge is that really statistically you’re not going to have a lot of kids get NEC. Even in a high rate NICU, you’re going to have a lot of babies who don’t get it, and a few babies who do. But the outcomes can be so devastating for those few babies. So the simple part is really important, and the other question is do the interventions of NEC Zero affect other outcomes? And really, the answer is yes, because interventions are things like human milk standardized feeding protocols, antibiotic stewardship—those things are good for any baby— STEPHANIE: Right. DR. GEPHART: Any baby! So the good thing is that any NICU clinician can implement those things with relative confidence. Now, the big wildcard here that people don’t agree to consistently is holding feeding during transfusion. So that piece is a little bit controversial, actually it’s a lot controversial right now, but that component—the health system I’m working with has already adopted a practice to do that, so that is part of our bundle, and we’re going to keep it that way, but as we get into the literature about transfusions and NEC, it is somewhat controversial, and the evidence is not really conclusive. STEPHANIE: Right. We actually had an episode with a Dr. Hussain from Connecticut Children’s Medical Center, and in his conversation about transfusion associated NEC, he had mentioned GutCheckNEC. So it does seem to sort of all circle around. DR. GEPHART: It does, and the thing with GutCheckNEC is that transfusions is a risk factor. So in our structured communications protocol, which is coupled with GutCheckNEC, understanding the context of if a baby has been transfused in the last 48 hours, that’s a trigger. STEPHANIE: Right. DR. GEPHART: So those two pieces put together do heighten our awareness of what a baby could be at risk for. STEPHANIE: This was a really great conversation, Sheila. I really appreciate you sharing all of this. A lot of this, even though I have done a lot of research myself is pretty new in this context to me. So I think it really sort of simplifies some really complicated information. So I appreciate you sharing this with us. DR. GEPHART: Well, it’s been my pleasure and honor to try to simplify things. I have to do that for my own brain. I will say that this is an audacious goal. STEPHANIE: Right. DR. GEPHART: People look at me cross eyed when I say NEC Zero. They think what are you talking about? Is that possible? But I will tell you that there are a handful of NICUs across the country who are getting to zero with their NEC rates, and they are models. STEPHANIE: Right. DR. GEPHART: The things they consistently do are they prioritize human milk feeding, it is critical, they use standardized feeding protocols, they start feedings early with trophic feedings, which is just small feedings, and they generally have a fairly specific approach to handling transfusions and feeding. So those things are very important. But the human milk is essential. STEPHANIE: Right. Right. So before we wrap up, is there anything else with regard to NEC or your research moving forward that you would like to share? DR. GEPHART: I appreciate that offer. I would like to just emphasize how we do have evidence. We have pretty good evidence about things that prevent NEC. Now, does that mean that we’re going to prevent every single case of NEC? I don’t know that yet. STEPHANIE: Right DR. GEPHART: But we have pretty good evidence, and one of the things that’s pretty controversial in our country right now is the use of probiotics. I don’t know if any of your experts have gotten into that realm yet, but- STEPHANIE: We’ve touched on it and they’ve sort of said the same thing you did that it is sort of a controversial topic because if I’m saying this correctly, the FDA regulations and the procedures around that, but I know in other countries that they have seen reduced rates of NEC with probiotics. DR. GEPHART: Right, right, and that is one thing that I would say is certainly controversial. There is one of the NICUs that I’m aware of that uses probiotics. They’ve been at zero for like six years. One of the issues we have, I’ve spent a lot of time lately understanding the strength of evidence for all of these components that prevent NEC, we don’t have randomized control trial evidence for most of them. But we have 24 randomized control trials that show a decreased risk for NEC with probiotics—thousands of babies—thousands, and even some people will say the preparations are different in these different studies, there is a recent study that actually pulled the results from just a certain type of probiotic and they still showed benefit. So the issue here we have in the United States is that probiotics are marketed as a food product. And so as a food product, their regulation is different with the FDA than as a medicine. STEPHANIE: Right. DR. GEPHART: However, I think parents should know this, frankly. STEPHANIE: Right. DR. GEPHART: I think this is one of those opportunities for shared decision making in the NICU where a physician, a nurse practitioner could bring up this issue with parents to say hey, look, we have this opportunity to give your baby probiotics and this is what is available, this is the evidence, this is the risk. See, this is shared decision making. STEPHANIE: Right. DR. GEPHART: You go and you have a test, your physician or nurse practitioner would say this is how you have to decide what’s important, but I think NICU parents are very, very smart people, and I think we’re at the point in the United States where it is time to open up the conversation about probiotics to make it a joint decision versus an “oh, we’re just not going to do it”. STEPHANIE: Right. DR. GEPHART: Because we have such strong evidence, it’s just that most of those studies were not done in the US. STEPHANIE: Right. DR. GEPHART: However, there are many things that have been developed in other countries that we can adopt. The other issue is a standard formulation, a safe, standard formulation. There was a case of sepsis a few years ago that was very concerning—that’s severe widespread infection in a premature baby. That is the risk. So that’s what the clinician would say to the parent. But it’s very, very small risk if you look at all of the benefits. STEPHANIE: Right. DR. GEPHART: So I’m not going to pretend we should be using probiotics, but I do think that parents need to start asking for them. They need to start asking why are we not using them… STEPHANIE: Right. DR. GEPHART: ..because we have such strong evidence. So we have actually stronger evidence for probiotics than we do for antenatal steroids or Surfactant. Those are common, important, consistently delivered interventions for NICU babies. But you have risks, and that’s the issue. STEPHANIE: Right. DR. GEPHART: So we’re at a place for decision making. STEPHANIE: Right. And actually ironically, or maybe not ironically, I know that my boys did get probiotics, and that was five years ago that they were born. DR. GEPHART: That is ironic. STEPHANIE: We had an anomaly with Morgan. Nobody can sort of figure out why he got NEC when he did, but we did do all of the sort of standard care practices, probably even advanced practices for five years ago, and we had one that got it and one that didn’t. So…but knowing now what I have learned is they were doing the very best practices at the hospital where my sons were born. So I think we were at the right place at the right time and had the best outcomes that we could hope for. DR. GEPHART: That’s awesome. That’s awesome. Did you feel like with Morgan that they were able to recognize it pretty fast and act? STEPHANIE: I really think they did. I think that is probably the key that saved his life because he developed NEC at four days old and had really only had two trophic feeds, and it was colostrum. DR. GEPHART: Okay. STEPHANIE: Actually after the conversation that I had with Dr. Hussein, I went back and looked and he did not have a blood transfusion within that timeframe, so he sort of, it’s my understanding he’s just sort of an anomaly, but that’s why we’re looking to the researchers to piece together all of these things. That’s sort of what drives me is he doesn’t easily fit into something that could have, should have, would have, maybe been different and that seems to be the riddle that’s NEC. DR. GEPHART: Sure. There’s an analogy for this it’s called, a wicked problem, I don’t know if you’ve heard of that term, but you were at my talk when we were in Connecticut,… STEPHANIE: Right. DR. GEPHART: ..and I talked about the wicked problem and how it’s like a forest fire, it’s not easily solved. There’s a lot of pieces to it,… STEPHANIE: Right. DR. GEPHART: …and I think NEC is really the neonatal wicked problem. STEPHANIE: Right. DR. GEPHART: So I’m so glad that Morgan got care so quickly and got such excellent care. And that’s the thing is that clinicians, physicians, dieticians, lactation consultants, nurses, nurse practitioners, they want to do the absolute best for your baby. STEPHANIE: Right. DR. GEPHART: Nobody has ill will. This is a team effort, but they’re human, and that’s the thing with wicked problems… STEPHANIE: Right. DR. GEPHART: ..is that you have humans operating in these complex systems, and trying to deal with things and what we know with solving wicked problems, like forest fires, it’s a combination of boots on the ground, and standard protocol. STEPHANIE: Right. DR. GEPHART: So it’s the strength and protection of both approaches that really is effective, maybe not taking away completely the wicked problem, but at least confronting it. STEPHANIE: Right. DR. GEPHART: So I’m so glad that Morgan got such great care. STEPHANIE: Thank you. We are too. We are too. And like I said, I think it goes to show that I’ve heard multifactorial used and all kinds of big words with regard to NEC, and just knowing that there are researchers out there like yourself who are trying to distill this information and simplify it for parents and practitioners as well that this is one of the ways that I think we will get to zero NEC. That’s our goal as well. So I really appreciate you talking to me today, and would love to talk to you again, and any of these links when the website is up, would love to share. So thank you! DR. GEPHART: Absolutely. It would be my honor to share those. It’s been fun to be with you. STEPHANIE: Thank you. You too. Direct links to more information about the GutCheckNEC can be found in this episode’s show notes. In closing, I’d like to share a few thoughts about today’s conversation with Dr. Gephart. Simply put, information is power. I believe that a risk assessment like GutCheckNEC can empower parents in the NICU by distilling complex medical information, and presenting it in a simplified, and actionable way. Morgan was diagnosed with NEC at four days old. My husband and I were still in shock, and hadn’t even begun to come to terms with our twin sons’ unexpected and traumatic birth, when Morgan was transferred to another hospital and underwent emergency surgery. In the days and weeks that followed, I diligently called two NICUs every morning after rounds for updates on our two babies. I took copious notes to share with my husband on weight gains, Oxygen levels, and whatever else each nurse made mention of during the phone calls. And during our daily visits, we spoke with each baby’s nurse personally about all of the day’s happenings. Since then, I’ve learned a lot more about prematurity and NEC. And if we were in the same situation today, I would have a lot more questions to ask about all areas of our babies care. In retrospect, I realize we didn’t know what questions to ask. We took our lead from the nurses, and we looked to them to tell us what we needed to know. GutCheckNEC presents parents the opportunity to learn what questions to ask about NEC. Objectively. And, proactively. And, it can help open up the dialogue between parents and caregivers in advance of potential crisis. Show your support for our smallest and most fragile babies, those who have the greatest risk for developing NEC. Show your support for continued research in NEC. And join our effort to raise awareness about, and funds for research in NEC by making a donation to Morgan’s Fund at morgansfund.org/donate. If you’ve had a personal experience with NEC and would like to share your story, or have a question or topic that you’d like to hear addressed on our show, e-mail us at feedback@morgansfund.org. We’d love to hear from you! Additional Information You can make a donation directly to Dr. Gephart’s research in NEC at the University of Arizona College of Nursing by visiting https://www2.uafoundation.org/NetCommunity/SSLPage.aspx?pid=341 You can become a donor to the College of Nursing by visiting http://www.nursing.arizona.edu/giving/leave-your-legacy Copyright © 2015 The Morgan Leary Vaughan Fund, Inc. The opinions expressed in Speaking of NEC: Necrotizing Enterocolitis (the Podcast series) and by The Morgan Leary Vaughan Fund are published for educational and informational purposes only, and are not intended as a diagnosis, treatment or as a substitute for professional medical advice, diagnosis and treatment. Please consult a local physician or other health care professional for your specific health care and/or medical needs or concerns. The Podcast series does not endorse or recommend any commercial products, medical treatments, pharmaceuticals, brand names, processes, or services, or the use of any trade, firm, or corporation name is for the information and education of the viewing public, and the mention of any of the above on the Site does not constitute an endorsement, recommendation, or favoring by The Morgan Leary Vaughan Fund.

Jennifer Canvasser. Photo courtesy of Jennifer Canvasser. Episode 7 features Jennifer Canvasser, Founder of the NEC Society, and Dr. Samir Gadepalli, NEC Society scientific advisory council member. In 2014, Jennifer founded the NEC Society, a non-profit organization dedicated to protecting fragile infants, after losing her son, Micah, to Necrotizing Enterocolitis. During the episode, Jennifer and Samir share the findings from the NEC Society’s survey aimed at characterizing parent perceptions of the practices and events related to their child’s development of NEC. They discuss: The design and development of the NEC Society’s online, international survey—research specifically focused on parents and their perspectives on NEC, The survey’s five areas of interest: education, awareness, support of human milk, information provided and information providers, and parental empowerment in the NICU, The survey findings including the demographics of the participants and their babies—all of whom were diagnosed with NEC, The importance of raising awareness about NEC in the general public, The NEC Society’s partnership with the Best for Babes Foundation® and the Miracle MilkTM Stroll, and The NEC Society’s recently announced conference, Necrotizing Enterocolitis Symposium: A Transdisciplinary Approach to Improved NEC Outcomes, in partnership with the University of California at Davis, and set for 2017. Copyright © 2015 The Morgan Leary Vaughan Fund, Inc. This episode was produced in part by the TeacherCast Educational Broadcasting Network. [powerpress] STEPHANIE VAUGHAN, HOST: Welcome to Episode 7 of Speaking of NEC—a free, audio podcast series about Necrotizing Enterocolitis. Produced by The Morgan Leary Vaughan Fund, and funded by The Petit Family Foundation, Speaking of NEC is a series of one-on-one conversations with relevant NEC experts—neonatologists, clinicians and researchers—that highlights current prevention, diagnosis, and treatment strategies for NEC, and the search for a cure. For more information about this podcast series or The Morgan Leary Vaughan Fund, visit our website at morgansfund.org. Hello, my name is Stephanie Vaughan. Welcome to the show. I’m the Co-founder and President of The Morgan Leary Vaughan Fund. Today, my guests will be Jennifer Canvasser, Founder of the NEC Society—whose mission is reducing the incidence of Necrotizing Enterocolitis through education, outreach, research, and advocacy, and the NEC Society scientific advisory council member Dr. Samir Gadepalli. During our conversation, they will discuss in varying degrees: The design and development of the NEC Society’s parent survey—research specifically focused on parents and their perspectives on NEC, The survey’s five areas of interest: education, awareness, support of human milk, information provided and information providers, and parental empowerment in the NICU, The survey findings including the demographics of the participants and their babies—all of whom were diagnosed with NEC, The importance of raising awareness about NEC in the general public, The NEC Society’s partnership with the Best for Babes Foundation® and the Miracle MilkTM Stroll, and Plans for their upcoming conference Necrotizing Enterocolitis Symposium: A Transdisciplinary Approach to Improved NEC Outcomes in partnership with the University of California at Davis. With that in mind, let me introduce my guests today. Hi, Jennifer and Samir. Thank you for joining me. How are you guys? JENNIFER CANVASSER, GUEST: Great. Thank you. SAMIR GADEPALLI, GUEST: Great. Thank you. STEPHANIE, HOST: So let me have Jennifer take a few minutes and introduce herself. She’s got a very compelling story with her son Micah, and has done some wonderful work based on a tragic situation with Micah, so let me have you share your story. JENNIFER, GUEST: So, my name is Jennifer Canvasser, and in January of 2014, I founded the NEC Society. It’s a nonprofit dedicated to the prevention of Necrotizing Enterocolitis in fragile infants. And, it was because my son Micah passed away from complications related to Necrotizing Enterocolitis when he was 11 months old. And so really, the organization is dedicated to reducing the incidence of this devastating disease and making progress to bring families, clinicians, and researchers together to collaborate and make improvements on protecting babies and families. STEPHANIE, HOST: Excellent. Thank you. And Samir, can you talk a little bit about your experience with NEC from the surgical perspective, and how you came to know Jennifer and get involved? SAMIR, GUEST: Yes. So, I’m Samir. I’m one of the pediatric surgeons at Mott Hospital (C.S. Mott Children’s Hospital). I actually had the privilege of taking care of Jenn and her kids, and that’s how I met them. In fact, her husband Noah rotated on our service when he was an intern, and so I got to know the whole family in different aspects. For me, my experience with NEC really is related to the fact that as a pediatric surgeon it’s one of the things that you see a lot of, and it’s a very devastating disease and somewhat frustrating because outcomes are fairly miserable and you just wish there was a better way of handling this. There really hasn’t been a huge difference in‚—depending on who you ask‚—30 or 50 years. And so as a junior faculty member, one of the areas I had primary interest in was in Necrotizing Enterocolitis, and ways to approach it in a different way, because whatever we’d been trying for 30 or 50 years definitely hasn’t worked. I shouldn’t say that. I would say there’s been some progress, but the reality is it’s not as much as you would like it to be. And so, one of the opportunities that came up was when Jenn called me one day and said, “Hey listen, I was interested in starting a society focusing on NEC, empowering and educating families.” I said, “This is fantastic. This is exactly what I was looking for.” And so both of us kind of talked over the phone, and I sent her various ideas that I was thinking about and ways that I was hoping to approach it, different than it’s been approached before in terms of collaboration, and empowerment, and bringing different ideas together. And so, both of us talked about ways that we can get other people involved, not just clinicians but also researchers, parents. And she did all the legwork in terms of the NEC Society, and getting all these various members across the country on board who are all experts and are invested in solving the problem of NEC. And so, both of us wanted to try to invigorate the group and get them to start focusing on ways to work together and collaborate, so one of the things that we realized is one of our opportunities was to try to get a survey going and also to‚—how do you get a bunch of researchers to work together is research. That was a chance for us to motivate people in our group, and to start thinking of ways to approach the disease that hadn’t been done before. STEPHANIE, HOST: That’s great. So, can you talk to me a little bit about how the survey was actually designed, and maybe the major components or question topics? SAMIR, GUEST: Sure. What we did was we wanted to survey all the family members because we had access to over 200 parents across not just this country, but internationally, who all had an experience with NEC, various different types of approaches, different experiences and outcomes. We wanted to survey both demographics and see what kind of population we had, and also look at what their experience in the NICU was in terms of what kind of education they were provided, how much empowerment they had in decisions, who provided the education, what did they know about it beforehand, what kind of awareness existed, and so forth. And then we wanted to see if there was something that we could learn from and we can focus on in the future for our society to work on. I created a design, but then I showed it to Jenn to see if this is something, one, that’s easy to take and feasible and can be done within a few minutes and wouldn’t be inconvenient; it wouldn’t create any sort of PTSD (Post Traumatic Stress Disorder) for families who’ve been through a very traumatic experience. But also, we wanted to make sure we highlighted areas that we thought the families could access, and so there were quite a few open-ended questions within it. We didn’t want it to be cumbersome but it get enough data that we could use. Sheila Gephart (PhD, RN, from the University of Arizona College of Nursing) is someone who has a lot of experience using qualitative data and looking at Necrotizing Enterocolitis, and she played a valuable role in terms of the information we were trying to collect. Dr. (Jae) Kim, from (The University of ) California, was also very useful because he has a ton of experience treating patients with Necrotizing Enterocolitis. Between the four of us‚—Jenn, myself, and those two‚—we created the survey. We went over it with our scientific advisory council to make sure that everyone was in agreement with the type of questions we asked. Then we just sent out the survey via email, and our response rate was amazing. Pretty much everyone who got the‚— they were invested in it, and that’s one of the reasons why they decided to join NEC, I think, the NEC Society, was because they wanted to make a difference and let their voice be heard. STEPHANIE, HOST: Right. JENNIFER, GUEST: I think it was really empowering for the families who had been through these traumatic experiences that Samir is talking about to be able to have their voice heard, like he just said. They found it very empowering to share their experience with the hope of helping future families. STEPHANIE, HOST: Right. Right. So can you talk to us about what you found in the study specifically? SAMIR, GUEST: Sure. I think in order to really understand the study you have to start out with the demographics of the population. I think Jenn has the numbers right in front of her. I was trying to bring it up on my computer. But basically, it’s highly educated, mostly Caucasian, but college graduates who were part of this society, so they were online, and they had an interest and investment. They already had a lot of education and background. When you look at the study, you kind of think, okay, so here’s a population that has a lot of exposure and experience in life and should probably know a lot about NEC. This is a disease that affects a lot of premature infants. But then when you look at the data, when we went through it, it was kind of like pretty sad in terms of what it showed in our different healthcare systems. It wasn’t just us, as in United States, or us in Michigan or us in anywhere. It was internationally. It shows you how not-so-good we are at educating families and empowering families. Jenn, you want to comment? JENNIFER, GUEST: Yeah, I just want to add something else that’s very interesting is that nearly 90% of the children of these parents who responded were born after 2010, and so this is a very recent occurrence. STEPHANIE, HOST: Right. JENNIFER, GUEST: So and so this wasn’t 15 to 20 years ago. This is happening now—in NICUs now. So I think it’s important to note that. STEPHANIE, HOST: And do you want to talk to any of the specific measurements that you saw, or any topics that were maybe better than others, or ones that specifically need more improvement? SAMIR, GUEST: We focused on five primary areas that we thought were important for us to hit. One of them was education. One of them was awareness. One of them was support that was provided in terms of using human milk or breast milk. One of them was regarding who provided information and what information they were given. And one was related to empowerment within their NICU experience. We found that they were predominantly‚—the kids were mostly 28 weeks gestational age, and 90% of them were less than 1800 grams (3 pounds 15.5 ounces). The majority were treated in a pediatric unit within an adult hospital, 55% of them, but about 25% of them were at a free-standing children’s hospital. And then the geographic distribution was pretty diverse, from all regions of the United States. About 12% of them were international. Many were treated at multiple centers, transferring to a higher level once NEC was diagnosed. They were diagnosed at median age of 31 weeks, so about 3 weeks of age. And the survival rate was about 64%, and about 71% had surgery. And of those survivors, about 44% of them had short bowel syndrome. Of those who passed away, about 60% of them were in the first month of life. So, it’s kind of a heterogeneous group, but pretty much the major outcomes that you would expect with NEC were seen. STEPHANIE, HOST: Okay. SAMIR, GUEST: About 15% of them worked in the medical field, and so when we looked we said, okay, so they may know a lot about the disease, but we found out that about 40% of the parents were informed only after the baby was diagnosed with Necrotizing Enterocolitis. And 23% of them felt that no information was actually provided about NEC. So, most of them were not satisfied in the amount of information that was provided. Only about a third of them thought they were pretty satisfied. These are much smaller numbers than we had hoped for. In support for breast milk, there was a huge variability. About 84% of the parents met with a lactation consultant after the baby was born, and about 60% on the first day. However, about 10% of them were never offered an opportunity to meet with a lactation consultant, and only 5% of the patients met with a peer counselor for lactation support. So, I think there were some areas that we did okay, but there were a lot of areas that we can work on. STEPHANIE, HOST: Um-hmm. SAMIR, GUEST: About three-fifths of the babies received donated milk, but many of them didn’t even know about the existence or weren’t even told about it. About 30% of them felt they felt pressured to give their baby formula. The surprising thing is more than half of the parents, about 54%, felt that their child’s Necrotizing Enterocolitis was preventable. And many of them, of those who developed short bowel syndrome, felt this way. STEPHANIE, HOST: Oh, wow. SAMIR, GUEST: About 56% of the parents suspected that something was wrong prior to the diagnosis of NEC, and all of them notified the medical staff except for one of them, but in less than half of the instances was anything ever done. And you have to realize, this is broad. It’s not like we picked on one institution or one region of the country… STEPHANIE, HOST: Right. SAMIR, GUEST: …or we picked on a population that was not well educated or had poor socioeconomic status. This is after 2010, and this is a population that’s well educated, that has access to Internet and is willing to provide feedback, and is an empowered community. STEPHANIE, HOST: Right. SAMIR, GUEST: This doesn’t even reflect the population of NEC. STEPHANIE, HOST: What would you want to say to the parents that are listening, questions that they should be asking, and things that they should be looking for when they’re in the NICU? JENNIFER, GUEST: Right. We actually have, if you just Google, “10 Things All Parents of Preemies Need to Know.” When we developed this, we really had NEC in mind, but you can generalize it to any fragile infant, or any hospitalized child, for that matter. But specifically for babies that are at risk for NEC, this “10 Things All Parents of Preemies Need to Know” is very helpful, and it talks about asking questions and being involved in the care team, the importance of an exclusive human milk diet. We often hear a lot of families say, “Well, my baby did get breast milk,” but the breast milk is often fortified with formula, and we know that formula does increase the risk of NEC. So just making sure that they’re involved, and their voice is being heard, and they’re developing a primary care team. There’s some things that I hope people will check out, again, “10 Things All Parents of Preemies Need to Know.” Those are kind of the biggest things, and one of the other goals that we have for the NEC Society is to raise awareness for families who are not in the NICU right now, because even in my own personal experience there are many families who aren’t in the NICU now, but they’re going to end up in the NICU five years from now, or whatever it might be, or they have friends that are. Necrotizing Enterocolitis is one of the leading causes of overall infant mortality in the United States. It kills about 500 infants each year, but practically no one knows what NEC is until it happens to them. STEPHANIE, HOST: Right. JENNIFER, GUEST: And we’re really hoping that we can work to change that and raise awareness just in the general public, because I think when you raise that awareness in the general public there’s more at stake and more people are invested in making a change and protecting these babies and can put more resources and finances and more energy into preventing this disease and reducing the outcomes. STEPHANIE, HOST: Right. Yeah, we couldn’t agree more. And I think you guys have taken a wonderful avenue. Ours is probably the flip side in looking at how we can help advance research through funding and that area. I’ve been on your website and have been following you, and I think you guys are doing wonderful things. JENNIFER, GUEST: Thank you. And same to you. STEPHANIE, HOST: Oh, thank you. Anything that you would like to share about other things that you are doing, or other points study related or not, please feel free. JENNIFER, GUEST: Do you want to mention anything else about the survey and the research, Samir, before we get into other topics? SAMIR, GUEST: In terms of the survey, we presented at different forums not for recognition per se as much as just awareness and creating that there is a need here, that partnering with parents and partnering with decision makers is not commonplace in medicine in general, but yet this is an area where we think it’s super key to do, because I think that access to donor milk or access to human milk is a priority in a lot of these babies, and there’s probably a lack of awareness overall. And improving quality in our NICUs is going to be through better communication and teamwork with families, early education engagement of families rather than just waiting until a disease happens, because I think a lot of parents don’t quite realize how much power they do have, and how much control they do have over the outcome of their child. JENNIFER, GUEST: We are hoping that we can eventually get this published and share more of the results and the information and just get this information out there and use it to help better the practices in other hospitals for other families. So we’re not done, basically, with the work. We’re hoping to continue the momentum and continue to use what we have learned to improve practices. And then, the other thing I wanted to mention is over the past couple of years, we have partnered with and organization that’s fantastic. It’s called the Best for Babes Foundation. They have dedicated what’s called a “Miracle Milk Stroll” to raising awareness about the life-saving power of human milk for fragile infants. Studies have shown that an exclusive human milk diet for fragile babies can reduce the incidence of NEC by nearly 80%, yet many, many NICUs aren’t providing donor milk, and many institutions are not telling families how important it is to provide human milk. And so families are in a very difficult situation when you’re having a premature baby, and if you’re too overwhelmed to pump or you’re at a different hospital than your baby and you can’t get them your own milk, how important donor milk can be. Basically, we’ve partnered with the Miracle Milk Stroll with the Best for Babes Foundation to, one, raise awareness just through the general public, and it’s really been amazing to see the media coverage of this event, because it’s become international with hundreds and hundreds of locations all around the country and even internationally who together stroll in honor of these babies and raising awareness about the life-saving power of human milk. So one is to raise awareness in the general public. It’s also to increase human milk donations to milk banks. Because again, these babies need donor milk if their mothers aren’t able to provide it. And then, it’s also a fundraiser. So, it’s raising funds to help, again, protect these babies and making sure that they are getting access to the life-saving milk that they definitely need. So that’s one thing that we’re really honored, and so proud, and excited to be able to do, so we’ll be doing that again. It’s in the spring, kind of around May of each year, so we’ll be doing that again next year. It’s called the Miracle Milk Stroll with the Best for Babes Foundation. Another project that we have just started working on is the first conference on Necrotizing Enterocolitis in the United States. We just received an award from PCORI to host this conference. It will be in the spring of 2017 in conjunction with UC Davis in northern California. And it’s going to be a collaboration, again, between families, clinicians, researchers, and others who are dedicated to reducing this disease, and it’s going to be focused on prevention and just improving outcomes, so we’re really excited about that. And, Samir, please feel free to add anything you might want to about the conference. SAMIR, GUEST: Sure. Stephanie, consider yourself invited. STEPHANIE, HOST: Thank you. Yes, congratulations. SAMIR, GUEST: I think it’s an exciting first step because I think just getting people together to talk, and share all their ideas, and collaborate is going to be a huge step in the right direction. And this is our chance to put everyone on the same forum, on the same table, and just say, “You know what, these conversations need to happen.” JENNIFER, GUEST: Right. SAMIR, GUEST: I think a lot of the issue right now is the funders are on one page, researchers are on one page, clinicians are on one page, and the families are nowhere on the table. I think this is kind of a loss at how our system works right now. And this is our opportunity to bring everybody together and talk about the different ideas and what they’re working on and say, “Hey, this has hope. This has potential. We should start focusing on this as a group and have larger clinical trials.” This is what they did with cancer 80 years ago. This is what we should be doing with all other diseases, and yet NEC is not even on the map. And so, finally, we have a chance now, and PCORI has given us a chance to fund us to make this symposium happen. We’re planning on doing it in 2017 in northern California, like Jenn mentioned, and our hope is to get all different parties together‚—researchers, clinicians, anyone invested in NEC‚—to talk about the various issues, whether it’s related to prevention, management, outcomes, way to improve those. I think it will be a great chance. JENNIFER, GUEST: And I was just going to clarify really quick, PCORI stands for‚—and I want to make sure I’m saying it right‚—Patient-Centered Outcomes Research Institute, for people who are not familiar with PCORI awards. STEPHANIE, HOST: Well, congratulations again. I can’t imagine the work that went into trying to get that grant, and I think it’s a wonderful thing. And we will definitely be there, and support in any way that we can. JENNIFER, GUEST: I think that it’s just important to know that people like your organization and our organization exist, and we are trying to improve things for families and for babies, and that there is hope that things are hopefully going to be improving, and that there is a lot of room for improvement. I think that’s one key for hospitals and clinicians and NICUs, what have you, to understand is that there is a lot of room for improvement. STEPHANIE, HOST: Right. JENNIFER, GUEST: And I think that’s one thing that this survey really opened our eyes to. Parents have been saying, “I didn’t feel empowered. I feel like my baby’s NEC was preventable,” and now we have this information that really shows that, yes, there’s a lot of room for improvement, and we have these organizations out there that are working on doing just that. STEPHANIE, HOST: Right. Right. And I was amazed when we first started, at finding how many researchers and doctors have dedicated their careers to this disease. JENNIFER, GUEST: Right. STEPHANIE, HOST: And unfortunately, no one outside of that tiny community knows about it, or knew about it. JENNIFER, GUEST: Right. STEPHANIE, HOST: So just like you said, getting everyone in the same place at the same time, I think will be a phenomenal step forward. For more information about the NEC Society visit: necsociety.org. A direct link can also be found in this episode’s show notes: http://necsociety.org/ In closing, I’d like to share a few thoughts about today’s conversation with Jennifer and Samir. As the parent of a surgical NEC survivor, two things struck me about the findings of the NEC Society’s parent survey. First, the findings of this survey are extremely relevant because the parents’ perspectives are so very timely. As Jennifer pointed out, survey participants were parents of babies born in 2010 or later. So, these parent perspectives reflect current NICU practices as they relate to NEC. The fact that “54% the parents felt that their child’s Necrotizing Enterocolitis was preventable” is not only heart wrenching but also, in my opinion, wholly unacceptable. The second critical point that Jennifer made is that NEC prevention needs to start with the general public: before a baby who’s at risk for developing NEC is born, before they and their parents enter the NICU. We need to create an awareness of NEC among this next generation of parents. We need to create opportunities for education about NEC before they find themselves in the position of being the parents of a baby who’s at risk for developing NEC. I recently met a new mother of twins who were born at 34 weeks. She delivered her babies at a prestigious children’s hospital, and they spent two weeks in the hospital’s nationally ranked NICU. And, she never had heard of NEC. We’re fast approaching the tipping point. In the U.S., NEC is the second leading cause of death in premature infants, and the 10th leading cause of infant death overall. (Sources: UC Davis Health System and CDC/NCHS). We need to create an awareness about NEC through which we can educate and empower parents, and advance research for a cure. Show your support for our smallest and most fragile babies, those who have the greatest risk for developing NEC. Show your support for continued research in NEC. And join our effort to raise awareness about, and funds for research in NEC by making a donation to Morgan’s Fund at morgansfund.org/donate. If you’ve had a personal experience with NEC and would like to share your story, or have a question or topic that you’d like to hear addressed on our show, e-mail us at feedback@morgansfund.org. We’d love to hear from you! Additional resources: NEC Society. Perspectives from parents of infants impacted by NEC: NEC communication in the NICU. Poster presented at: Vermont Oxford Network Annual Quality Congress. 2014 Nov 1-2; Chicago, IL. About Jennifer Canvasser: Jennifer Canvasser has served on the Ecology Center’s children’s health, first food and environmental health campaigns since 2010. She completed UCSF’s Reach the Decision Makers Fellowship program in 2011, with a focus on reform of our national chemicals law. In 2014, Jennifer founded the NEC Society, a non-profit organization dedicated to protecting fragile infants, after losing her son, Micah, to necrotizing enterocolitis. She is a regular contributor to The Huffington Post on parenting, health and food justice issues. Jennifer completed her undergraduate studies at U.C.L.A. and earned her Master’s in Social Work from the University of Southern California with a focus on community organizing. Copyright © 2015 The Morgan Leary Vaughan Fund, Inc. The opinions expressed in Speaking of NEC: Necrotizing Enterocolitis (the Podcast series) and by The Morgan Leary Vaughan Fund are published for educational and informational purposes only, and are not intended as a diagnosis, treatment or as a substitute for professional medical advice, diagnosis and treatment. Please consult a local physician or other health care professional for your specific health care and/or medical needs or concerns. The Podcast series does not endorse or recommend any commercial products, medical treatments, pharmaceuticals, brand names, processes, or services, or the use of any trade, firm, or corporation name is for the information and education of the viewing public, and the mention of any of the above on the Site does not constitute an endorsement, recommendation, or favoring by The Morgan Leary Vaughan Fund.

Laura Martin. Photo courtesy of Laura Martin. Episode 6 features Laura Martin, expert parent, mom blogger at Joseph at Home, and the Director of Parent Communication and Engagement at Graham’s Foundation—a non-profit organization that supports parents of premature infants. During the episode, Laura shares her son Joseph’s story of prematurity and survival including his near fatal bout of late-onset NEC and the multitude of life-long complications that have resulted. She discusses: The extremely premature birth of her twin sons, Joseph and Campbell, at 24 weeks—four months early, and Campbell’s passing at 23 days of life, How Joseph developed late-onset NEC and lost two-thirds of his small intestine, Several of Joseph’s secondary diagnoses including Short Bowel Syndrome, Auditory Neuropathy Spectrum Disorder, Eosinophilic Esophagitis, and multiple food allergies—all resulting from NEC, How hers and her family’s experience with prematurity led to her work at Graham’s Foundation, Her personal blog where she documents her daily life as an expert parent of a child with special needs. Copyright © 2015 The Morgan Leary Vaughan Fund, Inc. This episode was produced in part by the TeacherCast Educational Broadcasting Network. [powerpress] STEPHANIE VAUGHAN, HOST: Welcome to Episode 6 of Speaking of NEC—a free, audio podcast series about Necrotizing Enterocolitis. Produced by The Morgan Leary Vaughan Fund, and funded by The Petit Family Foundation, Speaking of NEC is a series of one-on-one conversations with relevant NEC experts—neonatologists, clinicians and researchers—that highlights current prevention, diagnosis, and treatment strategies for NEC, and the search for a cure. For more information about this podcast series or The Morgan Leary Vaughan Fund, visit our website at morgansfund.org. Hello, my name is Stephanie Vaughan. Welcome to the show. I’m the Co-founder and President of The Morgan Leary Vaughan Fund. NEC is the leading cause of Short Bowel Syndrome or Short Gut Syndrome. The amount and location of intestine lost can result in life-long medical complications. Up to now, we’ve discussed NEC and its most common complication from the perspective of the neonatologist or surgeon. However, I feel that it is equally important to share the parent’s perspective. I’m privileged to have one such expert parent as my guest today. Laura Martin is the mom blogger at Joseph at Home, and the Director of Parent Communication and Engagement at Graham’s Foundation. She is also the parent of a fellow surgical NEC survivor. Laura will share with me today her son Joseph’s story of prematurity and survival including his near fatal bout of late-onset NEC and the multitude of life-long complications that have resulted. During our conversation, she will discuss in varying degrees: The extremely premature birth of her twin sons, Joseph and Campbell, at 24 weeks—four months early, and Campbell’s passing at 23 days of life, How Joseph developed late-onset NEC and lost two-thirds of his small intestine, Several of Joseph’s secondary diagnoses including Short Bowel Syndrome, Auditory Neuropathy Spectrum Disorder, Eosinophilic Esophagitis, and multiple food allergies—all resulting from NEC, How hers and her family’s experience with prematurity led to her work at Graham’s Foundation, Her personal blog where she documents her daily life as the parent of a child with special needs. With that in mind, let me introduce my guest today. This is Laura. Hi, how are you? LAURA MARTIN, GUEST: Hey, good. How are you? STEPHANIE: Good. Thank you for joining us. And Laura is a blogger at Joseph at Home and the Director of Parent Communication and Engagement at Graham’s Foundation. So I will let you introduce yourself and talk to me a little bit about your experience with prematurity and Necrotizing Enterocolitis. LAURA: Yeah. Our twin boys were born at 24 weeks gestation on Halloween morning in 2009. It came as a big surprise. It had been a perfectly clean, normal pregnancy. I had just had an appointment three days before, woke up with a dull backache about midnight. And Joseph was born first at 7:41 and his twin brother Campbell at 7:42. No rhyme or reason for the prematurity. It just happened. Campbell, unfortunately lost his battle to prematurity after 23 days of life. He just had a lot of complications from prematurity that he just couldn’t have overcome. Joseph went on to spend 228 days in the neonatal intensive care unit before he came home. He is now five and a half. He just started kindergarten. But it’s been a long journey to get here. We were two days from coming home when he was 5 and a half months old. He was about eight weeks adjusted. We had everything set up at home. We had oxygen. We had G-tube equipment. We had everything. We were ready. His room was ready. All of the clothes were washed. Two days before discharge, we got a call from the NICU that he was gray and bloated. And they were putting him on a ventilator. Let me back up a little bit. A few days prior to that, he had been showing some signs of infection. But nobody really knew what it was. He just had vaccines. He was running a little bit of fever. We contributed it to that. This pushed discharge back a little bit. But just two days before the initial discharge, when they called and said he’s gray and bloated, and they were putting him on a ventilator. You need to get here immediately. Our world kind of turned upside down, because we thought we were two days from home. And here we were not knowing what was going to happen. This was a Saturday, the day before Palm Sunday, 2010. And we didn’t know what was going to happen. The doctors kind of watched him throughout the Saturday, were taking X-rays every few hours. A little bit after lunch that day, one nurse practitioner came and said, his X-ray looks a little bit like NEC. Do you know what that is? And we said, of course, we know what that is. We’ve been in the NICU five and a half months. But he’s eight weeks adjusted. Why would be looking at NEC? We’ve been told once you get to your due date, you cross that off your list of things to worry about. And so, as the day went on, the night went on, it became very evident that he had Necrotizing Enterocolitis. They had seen this one other time in the NICU with a baby this old. He went through Saturday night. Things were not looking good. And on Sunday morning, the surgeon came to us and said, I’m going to take him to the OR. I’m going to open him up. And I’m going to see what happens. We don’t know what we’re going to find. So, on Palm Sunday, 2010, the surgeon took him to the OR. He was gone for several hours and came back halfway through surgery and sat us down in a room and said, here’s what I found. He has 41 centimeters (16 inches) of salvageable intestine. He said, he has 28 centimeters (11 inches) below his stomach, and he has 13 (5 inches) above his colon. Everything else in the middle is completely gangrenous. He said, we can take out the gangrenous intestine. And he’ll have two stomas for a while. Then we’ll go back in and reconnect. But he also looked at us and said, we don’t know what life for him is going to be like. It’s probably going to be very rocky. He may die before the age of two waiting on a liver transplant, because he’s going to be TPN dependent. If you want to close him up and let him go, I’ll respect your wishes. And, of course, we looked at him and said, no way, we’ve gotten this far. We’ve already lost one kid. We’re not doing this again. Go in there. Do what you have to do and save his life. So he went back. He was gone for several hours, came back to us. We saw Joseph, and it was amazing. Even though he had stomas, and he had just lost two thirds of his small intestine, he looked so much better than he had right before he went, because the infection was gone. A few days after that, they went in and placed a central line, because he was, of course, totally TPN dependent. He already had a G-tube before NEC, because of aspiration to his lungs. So we were fortunate with that that he already had the G-tube. But, as the weeks wore on, they were able to slowly decrease TPN, increase feeds, and decided after four weeks, he was ready for intestine reconnect, which was shocking. Nobody expected after four weeks he would be ready for intestine reconnect. So four weeks later, they went in, reconnected the intestines, told us we would probably be in another two to three months. He again amazed everybody—came off TPN very quickly, increased G-tube feeds to the point that they pulled his port before he came home. He never came home with a central line. And four weeks after his reconnect surgery, he came home—after 220 days in the NICU. STEPHANIE: That’s amazing. LAURA: So that’s how NEC came to be. Again, the hospital had seen one case of that. And it had been years and years and years. And people say, are you sure it’s NEC? Are you sure it was NEC? Yes, pathology confirmed that it was NEC. But who knows? Who knows why he had it at five and a half months old. STEPHANIE: Right, right. So just to back up, I’m curious what you knew about NEC before his surgery. You know, you had said that you had been in the NICU for now almost five months. And he reached his due date, so you were crossing it off the list. So I’m just curious, in general terms, what you knew up to that point. LAURA: NEC was one of those things that I remember learning about really early on in our NICU stay. Having 24-week twins, we knew that it was a very rocky journey. They both had less than 50% chance of survival. But my husband and I were the type that we wanted to know everything. We wanted to know what are things we have to look out for. What are things we need to be worried about? What are things that we don’t have to worry about? And it was within the first 24 to 48 hours that the nurse said there’s a thing called Necrotizing Enterocolitis. It doesn’t happen a lot. But it’s one of these things we watch for. We stay on top of it. So we knew about it from the beginning, but we had always been told that once you reach the gestational due date, you didn’t have to worry about it anymore. And while that is so true 99.999% of the time, there is a very small chance that it can happen later. And it’s almost one of those things I wish we had never been told—oh, yeah, you don’t have to worry about it when you hit 40 weeks. Because we did—we had completely crossed it off Right. So we know about it. And we knew what the warning signs were. We knew what to look for. Yet, again, when we look back on it, he had some of these warning signs two to three days before he got really, really sick. But why would—none of us thought it could be NEC. We thought, well, he’s had some GI issues. He has the feeding tube. He’s had his vaccines. It could be any other bug he’s picked up. He’s still in the NICU. But we knew what it was, but it was still just a huge shock that—I mean, he was 13 pounds at that point. He was a big kid, you know, for being in the NICU. STEPHANIE: Right, right. So he came home now, you said, four weeks after he had been reconnected. So talk to me a little bit about, I guess, those first days and first months when he was coming home—you know, again, sort of thinking from the perspective of things that we want to let parents and caregivers know, questions to ask, sort of things to look out for—so anything that you want to talk about, you know, his transition home and getting settled. LAURA: Yeah, he came home on complete continuous feeds via G-tube. So he was on feeds 24 hours a day because, of course, having NEC left him with short bowel syndrome. So he had a lot of dumping episodes, where it was out of control at times. We couldn’t really go anywhere because of the dumping syndrome. As the days went on, the weeks went on, the months went on, that got a little bit better. We were in and out of GI every 8 to 12 weeks, just checking in, making sure he was gaining weight. But a lot of doctors also didn’t really know what to do because he wasn’t TPN dependent. A lot of kids who come home with short bowel syndrome are TPN dependent. But here you have this kid who has only a third of his small intestine, but for the most part he’s tolerating formula well. He’s tolerating G-tube feeds. He’s gaining weight. He’s not going to need a port. Everybody was convinced he would have to have his port put back in. He never did. So that was actually, to be honest, a frustration for the first several years, is finding doctors who understood that, yeah, he is doing well. But he’s also not doing well. He only has a third of his small intestine. His weight gain is very slow. He still has periods of severe pain even today, from school. He still has periods where his belly is very distended. It took some time to find doctors who really wanted to help and say, yes, there really is still a problem here—with a kid who only has a third of his small intestine. That first year that he was home, he was rehospitalized five or six times, most of those with a GI bug. If he got any sort of stomach bug, we were in the hospital, because his body just couldn’t handle it. And so we were back in. Usually it would lead to a respiratory infection. He would spend a good week, 10 days, in the hospital. That was the first year. After that, I quit my job teaching, because we knew he had to stay home. He had to be healthy. And he had to grow. And as he’s gotten bigger, he’s gotten healthier. He has not been in the hospital for a GI bug in 3 and 1/2, 4 years. It’s been awhile. STEPHANIE: Oh, that’s great. LAURA: Yeah, now his body can tolerate it. You know, it’s not pleasant still. But we know what to do. But, as he’s gotten bigger, it’s gotten better. So, yeah, that was the first few years out of the hospital. STEPHANIE: We don’t have nearly the after-effects, but I remember Morgan’s transition home was pretty chaotic. LAURA: Yeah. STEPHANIE: His brother came home after 85 days, and I’m guessing was a much simpler transition, even just holding him in hands-on care and changing diapers. Morgan was very traumatized, I think, from being in the hospital and having the surgery. And we saw a big, big difference between him and his brother. So it was very scary as a parent that even simple things that you have to do was traumatizing to him. LAURA: Right. And then they can’t communicate with you to tell you that. And that’s what was so hard to watch early on, was you knew he was hurting. You knew he was in pain. But I didn’t know what to do to help, you know. So that was hard. Yeah. STEPHANIE: So, I guess, now that he’s getting a little bit older—you said he started kindergarten. That’s great. So how is he doing, I guess, developmentally? And are you seeing anything—you know, secondary diagnoses, I guess, maybe, strictly because of NEC or because of the short bowel or other issues that he’s having? LAURA: Yeah, he has several things that are going on. He did just start kindergarten. He’s in a special needs kindergarten. As a result—well, when he had NEC, he had to receive Gentamicin, which of course is an ototoxic drug. And the surgeon said, if we give this to him, he will probably lose all of his hearing. But if we don’t give this to him, he’s not going to live. Well, of course, it was a no-brainer decision. Before that, he had not passed his newborn hearing screening. But a lot of preemies don’t. So we kind of thought, well, we’ll get out of the NICU, he’ll pass it. He never did. While he was still in the NICU—this was in between NEC and the reconnect surgery—he was diagnosed with Auditory Neuropathy Spectrum Disorder, which is a hearing loss that comes and goes. It’s almost like you’re trying to tune a radio and there’s static. And that was what his hearing was like. So he received his first cochlear implant when he was three—three months after he turned three—because his hearing was rapidly deteriorating in his left ear. Just, not even two weeks ago, he received his second cochlear implant in his right ear. And we always go back to say, his hearing probably would have never been that great. But it’s definitely a lot worse post-NEC, because he had to receive the Gentamicin, the ototoxic drug, in order to kill the bacteria. Some other things that he has—July of 2014, he was diagnosed with Eosinophilic Esophagitis, which has been in question for several years. And we could not get the GI doctor to agree to do an endoscopy. He hated to do the endoscopy, because it meant putting him under sedation. Due to asthma, he didn’t want to do that. But at the same time, we’re battling with this increased amount of food allergies, knowing that that has to be a problem. Finally, they agreed to do the endoscopy. And it was clear that he had Eosinophilic Esophagitis. As a result of that, he has 15 food allergies. I’m happy to list them all if you want. But it includes all of the top 8 plus beef, chicken, rice, potatoes, watermelon, strawberry, pineapple, and a whole slew of medications. And I always tell people asking—it’s hard to know whether he would have had that regardless. Probably not. But having the Short Bowel Syndrome made it worse. He would not have had Short Bowel Syndrome if he didn’t have Necrotizing Enterocolitis. So to me it’s all sort of related. STEPHANIE: Right. Right. There’s definitely a domino effect. LAURA: It’s a domino effect. One thing has led to the other, which has led to the other. So it’s hard to know, some days, if you’re battling GI issues because of Short Bowel Syndrome. Or are you battling GI issues because of the Eosinophilic Esophagitis? Or are the white blood cells growing because he’s eating something he’s allergic to? Is there a new allergy? So some days we really struggle knowing what is what. And then you’ll have periods where he does great. And he’s like a normal kid. He does still have a G-tube. We were told he would lose the G-tube by two. But here we are almost six, and we still have the G-tube. Many days I wish we didn’t. But there are many days we couldn’t do without it. And if he doesn’t feel like eating or he’s in pain, we have the G-tube. And it’s literally been a lifesaver. And if he’s been sick, we can always get fluids in him. I would love to see it go. But I don’t see it going any time in the future. He doesn’t know life without it. He’s had it since he was four months old. To him it’s second nature. He gets his G-tube feeds at school. He gets them at home. They travel with us. But it’s truly a lifesaver for him. But it helps him gain weight. It’s what helps him actually be on the growth chart as a short-bowel kid. Many short-bowel kids, I think, are failure-to-thrive. He has never even been remotely considered failure-to-thrive, which is huge. So, yeah, there’s a lot of complications as a result—what I feel like, had he not had NEC, wouldn’t have led to X, Y, and Z probably. He does have development delays. But a lot of it is that he spent so much time in the hospital. Then there was the hearing issue, but he could not get a cochlear implant because he wasn’t healthy enough to have surgery. So it was just sort of this domino effect, and a spiral of getting out of it, and getting him healthy enough to be able to have surgery. And then you’re trying to catch up. You’re trying to catch up with language, fine motor, gross motor, it all, as well. But the kid we were told would never walk or talk, walked into kindergarten last week. So there’s so many things to be thankful for, and so many things that he’s doing so well on, that those are the days you really have to hold onto on the days he’s feeling really, really bad. You have to know that he’s going to get through it. Life will turn around, and it will get better. It’s just going to be interesting to see as he continues to grow, how much of this is just going to continue to get better. Will there be a decline at some point? We don’t know. Nobody really thought he would even make it to this point. STEPHANIE: Now, I’m just curious, sort of, personally, but also as a fellow parent of a NEC baby, have you talked to him at all about being in the NICU? Has any of that come up yet? I mean, I know he’s still sort of young. But I’m just curious. LAURA: Yeah, he knows he was in the hospital. When we drive by the hospital where he was born, he’ll say, that’s where I was born. That’s where my sister was born. He has seen pictures. He’s seen videos. But I don’t think he quite cognitively wraps his head around it. When he had a cochlear implant put in 10 days ago, it was at the hospital where he had NEC. And so we were able to kind of say, you were in the hospital here when we are a baby. A couple of the nurses stopped by to see him—they took care of you when you were a baby. But the cognition is just not quite there too. He sees his pictures. And he’ll say, I was very sick. And, yes, you were very sick—because he knows that his baby pictures look very different from his sister who was born full term. So he knows. He knows he has a G-tube. She does not. And so he’s starting to really realize those differences. STEPHANIE: Right. Yeah, I don’t think we’ve quite reached that yet. Shaymus deals with asthma. So he gets his puffs and he has, you know, different things. But I don’t think they’ve really lined up and taken notes on, you know, your picture has this. And my picture has that. Or you have this and I have that. But, yeah, sort of, it’ll be interesting to talk to them about it when they start to ask. Like, they just figured out that they’re twins this year. LAURA: Oh, that’s so funny. And my husband and I have talked about it. Gee, at what point in their life are they going to realize everything that they went through as a baby. And all these odds that were stacked against them. And all the times that they shouldn’t have lived. And will they be teenagers? Will they be adults? Will it be when they have their own children? My husband and I talk about this a lot. It’s just going to be interesting to see at what point do they kind of go, oh, wow, yeah, that really was what mom and dad went through and what I went through. It’s just fascinating. STEPHANIE: Yeah. So I would also like to let you talk about the work that you’ve done now because of having preemies and Joseph’s diagnosis. So you are the Director of Parent Communication and Engagement at Graham’s Foundation. So I’m happy to let you plug them away, and also to talk about your blog, which is Joseph at Home. LAURA: Yeah, I'll start with Graham’s Foundation first. I started working for them, gosh, about three and a half years ago in a different capacity. And it was one of those things that I was staying home with Joseph. And I was trying to figure out a way that I could give back to the preemie community. But I knew I couldn’t go into the NICU, because here I was with this child who got sick easily. And I knew that that couldn’t happen. So I started working for Graham’s Foundation, which was such a great outlet to be able to connect with other preemie parents, and sort of share stories—share stories with families who lost their child, with families who went through a long-term NICU stay, families who went through a short-term NICU stay. People will say, well I was only in the NICU 10 days. You were in seven and a half months. One day is one day too long for anybody to be in the NICU. And that’s what I always say to people. Nobody should have to go there. And if I can provide any sort of “it’s going to be OK,” I would love to do that. And so now, I serve as the Director of Parent Communication and Engagement. I do a lot of the writing for the blog for Graham’s Foundation, which is something we’re really trying to get off the ground. And through that, I also serve as a NEC mentor. So if parents come across our website and are looking to talk with someone who has experienced NEC, in no way am I a medical professional but I'm able to say: This is what we experienced. This is what we’re experiencing now. These are some questions you might be able to ask the doctor. And it’s been really nice to connect with people. Also, being five years out, to say, I promise you are going to get through this. When you’re dealing with, all along, doctor’s appointments, and you feel like you’ve got 18,000 things going on in one week. I’m here to tell you that I promise you, it gets better. The appointments get less and less and less. And it’s been so nice to connect with parents, and to offer that support from home, while I can still stay home with my kids and be able to work from home. And then also I have my personal blog, josephathome.com, which I started when I found I was pregnant with twins. I didn’t even share the blog address with anybody. My husband and I thought, oh, this will be great. We’ll update it. We’ll send it to friends and family. So as the pregnancy rocked along, I would sort of update it. I could never send out to anybody. And then when they were born Halloween morning, 2009, at 24 weeks gestation, I knew I didn’t have the energy to tell the same story over and over and over about what was happening. The texts were too long to send the information of what was going on. We had two of them, and I just couldn’t do it. And I was, like, oh, I’ve got this blog. This will be a great way to update people, so the long days of sitting in a hospital, my husband worked on our family tree. And I worked on the blog. That is just what we each sort of did to take our mind off of what was going on. And it was a great way, if somebody asked me a question, I would just say, read the blog. It’s on the blog. Just read the blog. I could share pictures—it just—because I wasn’t really in the mood to talk. We would talk to family, immediate family, and share with them what was going on. But it was just—it was so draining to tell the same story over and over and over. And if I just wanted to get something out there quickly, I would put it up. So, when Joseph came home, and I thought, well, I’ll keep it going. We’ll see what happens. It’ll probably die by the wayside. Well, five and a half years later—it’s almost six years later—it’s still going. And I write a lot now just about, of course, about prematurity, but also raising a special needs child and what that looks like, because we’re in this short-bowel world. We’re in the eosinophilic world. We’re in this hearing-loss world. We’re in the cochlear-implant world. We’re in the vision-impaired world. We’re in the mild cerebral palsy world, food-allergy world. And it’s just been nice to be able to connect with other parents and just to write about our real life and what it’s like. What it’s like. How do we deal with insurance? How do we deal with medical supplies? How do we travel? How do we do this, that, and the other? And it’s just a great outlet, too, just for venting, you know. And if I don’t want to talk about it, I can write about it. So we’ll see where it goes. It’s been a really nice outlet. But it’s also a great way to show Joseph, hey, this is where you started. This is where you are now. And it’s almost like a scrapbook, really, of his entire life, because it started the day he was born, and has everything. I just hit my—over 1,100 entries on it. STEPHANIE: That’s great. I commend you on that. I attempted, when I first came home from the hospital, to start recording things. And, I think, honestly, it was just too hard. I sort of thought to myself, I don’t want to remember this piece of it, so I sort of stopped. And I had scraps of paper where I would write down stats every day. You know, they gained this, and literally had, like, a pile two inches thick, by the time they came home, of daily weights and charts and things. Yeah, I mean, I’ve seen many of your posts. And I think they’re great. And I think it’s a great outlet. And, again, sort of that you’re not alone. And, you know, people are better off than you. People are worse off than you. And everybody’s sort of on their own journey. And I know preemie parents tend to minimize amongst other people, but your struggle is really your struggle and your family’s struggle. And no one should have to struggle. LAURA: No. And that’s what I’ve always said to people is, somebody out there always has something worse going on. Like, on Joseph’s worst day, somebody else has something worse going on. And that’s what I always say to people is, yeah, this is just our life in a little nutshell. But we’re so thankful for what we have. And, again, it could always be worse. You can just turn on the news every day and see that. But if it’s just, you know, if it can help one parent to say—and even sometimes I think people don’t like to say, well, this is not fair. You know what, sometimes it’s not fair. And it’s OK to say that and have a little pity party and then move on. And I enjoy being able to say to people sometimes. STEPHANIE: That’s great. So, I guess, is there anything else that you would want to mention if you had somebody in your position, however many years back, thinking to ask the doctors about, or transitioning home—coming home—how you sought out your specialists, if you’re not getting the answers that you think you should, how you proceeded, any sort of big-sisterly advice. LAURA: Yeah, I know, really. I think the big thing is to trust your instincts if you know that there’s something not right. We’ve gone through our fair share of doctors. Because if I feel like my child’s not getting the care that they need—and any parent would feel this way—I’m not going to settle for mediocre. I’m not going to settle for “he’s going to be fine” when you know in your heart that there’s still a problem. We were having some issues last year around the whole eosinophilic diagnosis. And I felt like we had run out of options where we live. And so I reached out to a doctor eight hours away. And he said, if you’re willing to travel, I’m willing to see him. I said, of course, we’re willing to travel. And so we did. He got us in. And we made the trip. And it was so nice to just connect with somebody who was a specialist in that field of Short Bowel Syndrome, to be able to say, yeah, he’s doing OK. I see that there are some problems. But you’re doing the right thing. And I think that’s become sort of my mantra is, don’t stop until you have the answers that you need. And there may not be answers. But I am not going to rest until I know that we have the answers we need. Like, we’re having some eosinophilic issues, so we’re working on getting into a top eosinophilic clinic. I don’t care how far we have to travel, because that’s what Joseph needs and it’s what’s best for him. And that’s what matters. It matters him feeling good. It matters him being healthy. It matters him growing. And he deserves to have the best life absolutely possible. And that’s what I would tell somebody if you’re just coming home. If you feel like something is not right, keep going and keep going and keep going. Yes, it’s exhausting. I think there are many days I’m asleep before my head even hits the pillow. But you have to do what’s best for your kid, because they can’t do it for themselves. You are their advocate. And that’s one thing that the NICU nurses taught us really, really early on—is you have to advocate for your child. Nobody else is going to do it for you. They can’t do it for themselves. You just have to keep going. And, again, it’s hard. You may hit brick walls here and there. Because goodness knows we’ve had our fair share with doctors. And it’s OK with doctors to speak your mind and say, you know, I don’t think you’re right on this. I think there’s more to it. You may upset them a little bit, because there’s no doubt I’ve upset a few. But it’s OK. It’s OK. Yes, they’re doctors. But they don’t have all the answers. You’re the parent. You live with your child day in and day out. You know their idiosyncrasies. You know what’s right and what’s wrong with them. And I think standing up for yourself is so important. And that’s what I would tell somebody coming out. You can’t be shy when it comes to advocating for your child who has special needs. STEPHANIE: I would agree. Yeah, we’re transitioning through preschool. And the boys were kindergarten eligible this year. But they’re actually being given an extra year of pre-K. And we had sort of that, uh, I’m not sure about this. I’m really not sure about it. I’m really not sure about it. And in the end they saw that—their teachers agreed with us. And the educational system agreed that, yeah, they’re a little bit immature. And probably going to kindergarten isn’t the best idea for them. And they really need the extra year. You know, they’re smart. Yes. But good enough isn’t good enough. We don’t want them to sort of eke by. We want to give them the best opportunities that they can have. So I agree with you wholeheartedly. LAURA: And it’s tough as a parent. I’ve had this conversation with a lot of people. My husband’s a teacher. I’m a teacher also. I’m not teaching right now. Hopefully one day I will be again. But it’s hard as a parent. It’s hard as a parent-teacher to have a child who has special needs and who needs that IEP (Individualized Education Program). It’s tough to sit on that end of the table as a parent. I mean, I’ve sat on the other end of the table as a teacher countless times. But, as a parent, it’s a tough pill to swallow, to say—and we know—I mean, Joseph started kindergarten. But we know full well he may need to repeat kindergarten. And while that’s tough to say, it’s a reality. We hope that he does great. But he may need to repeat. And if that’s what’s best for him, then that’s going to be what’s best for him. It’s tough to sit in an IEP meeting and hear how far behind he is. Or these are all the goals. And up to 21 pages now of his IEP. But it’s what he needs. And it’s what’s best for him. But I always go back to the day when one of our favorite NICU nurses—this was a long time ago—said, you know, one day he’s going to pull out a picture of him with all those tubes and wires and on a ventilator and say, see, mom, you remember this. And I have to think back to that, because, yes, it’s hard. And I kind of want to wallow in self-pity about, oh, I wish he was just in a regular ed class. He shouldn’t even be here. And that’s what I have to remind myself is, we had many days where we weren’t even sure we would see pre-K. And I know you’re the same way. We weren’t even sure he would see kindergarten. But here we are. And let’s just make the most of it. He’s loving every second of it. And that’s what matters. And so, being a preemie parent, as you know, it’s a journey that I never expected. But at the same time, I’m grateful for it, because it’s opened my eyes to a whole new area of life. STEPHANIE: Right. Well, I really appreciate you talking to me. And I think you’ve given some great advice—preemie parents or not, and NECs parents or not—on advocating for your child, and in every facet. So I really appreciate your time. And thank you so much. And if there’s anything else that you want to add, feel free. LAURA: If anyone wants to contact me personally, I’m happy to answer questions if there’s something that anybody wants to know more about. STEPHANIE: So great. Thank you. Thank you so much. LAURA: Thank you. STEPHANIE: For more information about Laura or to follow her blog, visit: josephathome.com. A direct link can also be found in this episode’s show notes. You can also email Laura directly at: laura [at] grahamsfoundation [dot] org. In closing, I’d like to share a few thoughts about today’s conversation with Laura. According to Dr. Besner, with whom I spoke about Short Bowel Syndrome in Episode 1, “if we estimate that a newborn baby has approximately 200 centimeters (78.74 inches) of intestine, they have to be left with at least 40 centimeters (15.75 inches) in order to be able to nourish themselves and get off TPN.” As a result of his bout with NEC, Joseph had only one centimeter (0.4 inches) more remaining. So first, I would like to take a moment to celebrate Joseph’s survival, courage, and strength. And that of his family. Both Joseph and his parents have shown remarkable resiliency while dealing with the daily effects of his bout with NEC. Second, I would like to reiterate that I strongly believe that a cure for NEC, once found, will have a far reaching impact not only on Gastroenterology (the digestive system and its disorders) as a whole, but also all of the patients like Joseph, and families like Laura’s. Show your support for our smallest and most fragile babies, those who have the greatest risk for developing NEC. Show your support for continued research in NEC. And join our effort to raise awareness about, and funds for research in NEC by making a donation to Morgan’s Fund at morgansfund.org/donate. If you’ve had a personal experience with NEC and would like to share your story, or have a question or topic that you’d like to hear addressed on our show, e-mail us at feedback@morgansfund.org. We’d love to hear from you! Copyright © 2015 The Morgan Leary Vaughan Fund, Inc. The opinions expressed in Speaking of NEC: Necrotizing Enterocolitis (the Podcast series) and by The Morgan Leary Vaughan Fund are published for educational and informational purposes only, and are not intended as a diagnosis, treatment or as a substitute for professional medical advice, diagnosis and treatment. Please consult a local physician or other health care professional for your specific health care and/or medical needs or concerns. The Podcast series does not endorse or recommend any commercial products, medical treatments, pharmaceuticals, brand names, processes, or services, or the use of any trade, firm, or corporation name is for the information and education of the viewing public, and the mention of any of the above on the Site does not constitute an endorsement, recommendation, or favoring by The Morgan Leary Vaughan Fund.

Dr. Martin Lee. Photo courtesy of Prolacta Bioscience. Episode 4 features Dr. Martin Lee, Vice President of Clinical Research and Development at Prolacta Bioscience. During this episode, Dr. Lee provides a comprehensive overview of a 100% or exclusive human milk diet in the prevention of NEC in extremely premature babies, those weighing less than 1250 grams (2 pounds 12 ounces) and who have the greatest risk for developing the disease. He discusses: * His transition from the blood industry to Prolacta, which developed of the world’s first human milk-based human milk fortifier * What constitutes a 100% or exclusive human milk diet * The clinical evidence showing a 70% reduction in NEC, an 8-fold reduction in surgical NEC, and a 4-fold reduction in mortality through the use of exclusive human milk diet * The importance of safety in the breast milk industry, including Prolacta’s rigorous product testing and donor safety profiles which parallel blood industry standards. Copyright © 2015 The Morgan Leary Vaughan Fund, Inc. This episode was produced in part by the TeacherCast Educational Broadcasting Network. [powerpress] STEPHANIE VAUGHAN, HOST: Welcome to Episode 4 of Speaking of NEC—a free, audio podcast series about Necrotizing Enterocolitis. Produced by The Morgan Leary Vaughan Fund, and funded by The Petit Family Foundation, Speaking of NEC is a series of one-on-one conversations with relevant NEC experts—neonatologists, clinicians and researchers—that highlights current prevention, diagnosis, and treatment strategies for NEC, and the search for a cure. For more information about this podcast series or The Morgan Leary Vaughan Fund, visit our website at morgansfund.org. Hello, my name is Stephanie Vaughan. Welcome to the show. I’m the Co-founder and President of The Morgan Leary Vaughan Fund. Today, my guest will be Dr. Martin Lee, Vice President of Clinical Research and Development at Prolacta Bioscience, which “creates specialty formulations made from human milk for the nutritional needs of premature infants in neonatal intensive care units.” Last October (2014), while attending the annual Preemie Parent Summit in Phoenix, Arizona, I had the pleasure of meeting Prolacta’s Chief Executive Officer Scott Elster. During our conversation, I was invited on a tour of the company. A few weeks later, along with a group of representatives from various preemie organizations throughout the country, I flew out California to tour Prolacta’s human milk processing facility, and to learn more about the people and research behind the company. I was highly impressed by all aspects of Prolacta from the manufacturing plant itself to the rigorous testing their products undergo throughout their processing. Even more impressive to me is the fact that everyone that we met at Prolacta has a personal connection to prematurity. The CEO himself is the parent of twins born prematurely. And, I was shocked to learn that one of the key reasons the company was formed, and their products developed, was to reduce the incidence Necrotizing Enterocolitis. The company’s reason for existing is the prevention of NEC. And the research presented to us by Dr. Lee was stunning. So when we began producing this series, it was only fitting to invite Dr. Lee to share the benefits of an exclusive human milk diet to premature infants and the clinical research supporting its use. With that in mind, let me introduce my guest today. This is Dr. Martin Lee from Prolacta Bioscience. And I’m so glad you could be with me here today. How are you? MARTIN LEE, GUEST: Good. How are you doing Stephanie? STEPHANIE: Good, good. So in previous podcasts, we’ve talked to doctors that are attending neonatologists and researchers. So I would like to give you the opportunity to give a little bit of your background and how you got involved with research in NEC. DR. LEE: OK. Absolutely. Well, I spent probably most of my career doing clinical research with various types of pharmaceutical and biotech products. I started with a company you’ve probably heard of called Baxter approximately 35 years ago, and I spent a good number of years working with them. And how that’s relevant to our discussion today is I was working with their group that manufactures blood products, and obviously blood is a significant human fluid, has many of the same issues with regards to safety that we have with breast milk. And so I learned a lot about some of the testing that needs to be done, some of the safety factors that we need to consider. And then I would say about 15 years ago, I met someone who was talking about forming a company who basically wanted to bring breast milk and breast milk products to premature infants so that they would have the benefit of receiving 100% human milk diet, particularly the smallest of the small premature infants. So together we started the company Prolacta. And the whole idea of course in starting the company was to put it‚…I think the most important thing was to put it on a firm clinical scientific basis. And that meant doing really important well-designed clinical trials to evaluate the most important morbidities like NEC, in particular, and even mortality in premature infants, infants certainly that had a high risk of both of those consequences of prematurity. STEPHANIE: OK. Maybe not all of the people that will be listening fully understand…what is an exclusively human milk-based diet? Can you get into that a little bit? DR. LEE: Absolutely. So obviously we know‚…we meaning pretty much the world understands that the best thing a newborn baby can be fed is mother’s milk. And for term babies, that is obviously going to be sufficient. They’re born at the right time and usually at a sufficient weight and mother’s milk has all the good things in it that help the baby to grow, help their immune system to develop, help their organs to develop, importantly it helps their brain to grow at the right rate. But a premature baby by definition is born too soon. And we specialize‚…the work that we’ve done at Prolacta,…specializes in the infants that are born as much as 27 weeks or 12 weeks premature so 27 weeks since the time of gestation. When those babies are born, they have a lot of problems obviously because they’ve come out of the womb way too early. And one of the things that of course they are is way too small. The average baby that we’ve studied in our research trials is less than a thousand grams. That’s around two pounds. Now most people know that the average baby is 6-7-8 pounds. And so they’re born so small that what happens is that mother’s milk which of course comes in when the baby’s born‚…nature didn’t intend mother’s milk to be able to feed these type of babies. This is an unfortunate consequence of something that happened with the mother, something that‚…injury, genetics, whatever it is that would cause a baby to be born premature, the milk comes in, but it cannot feed that baby well enough. And what I mean by that is the baby needs to grow. He needs to grow a lot. The baby needs to have their immune system protected by the mom’s milk, and so on and so forth. So obviously we always talk about mother’s milk being the thing for a newborn baby. It’s not enough for these premature infants. So what they need is what we call a fortifier, something with a little extra kick to the baby. And there are fortifiers that have been on the market for a long time. They’re made by the formula companies. And naturally these fortifiers are made from cow’s milk. And cow’s milk is not the best thing for a premature infant. It may not be the best thing for babies in general, but besides the point, it’s certainly not the best thing for a premature infant. So when we’re talking about 100% or exclusive human milk diet, we’re talking about mom’s milk; we’re talking about a fortifier which is necessary for the baby to grow and to be protected from infection and so on and so forth. That comes from human milk. And what Prolacta did was develop the world’s first human-milk human milk fortifier. And in fact, it sounds like a mouthful because when we talk about human milk fortifier, general people realize or may not realize that that’s a cow’s milk-based fortifier. We make the one from human milk. So that’s what we mean by 100% diet. And then one other thing just to add to that, Stephanie, is sometimes mom’s milk doesn’t come in enough or the baby wants it or needs to eat more, get more milk, so then there’s donor milk involved too. And that’s another aspect of the 100% diet. And of course donor milk is coming from other moms, which again provides the additional nutrition that the baby needs. And there you have the entire spectrum of what we mean by 100% human milk diet. STEPHANIE: OK. Thank you. Yeah, I know that there’s probably a bit of confusion amongst parents new to the NICU that human milk fortifier is a fortifier put into human milk, and not necessarily made with human milk. So I know that that does tend to cause a little confusion. DR. LEE: Right. STEPHANIE: So thank you for clarifying that. DR. LEE: Sure. STEPHANIE: So I guess I’ll ask you to go into a little bit of the research because I find it fascinating. As you know, we were out to your facility in November and I thought that this is a fabulous company. I was not aware of it when our babies were in the NICU and I will just make a tiny note that I know you’ve got significant statistics showing the benefit of human milk and exclusive human milk. Unfortunately for Morgan, he fell in to that other small percentage that I did pump. But he developed NEC so rapidly at four days old being born at 28 weeks. At four days old he developed NEC and I don’t think he had two feedings. So there are babies that get it even when all attempts are made to have an exclusive human milk diet. DR. LEE: Sure. STEPHANIE: And I also know that my other son, Shaymus, his milk was fortified, and to be honest, I’m sure it probably wasn’t with an exclusive human milk fortifier. So just some things to sort of give everyone background. And again, that was, you know, four years ago, 2010-2011. DR. LEE: Sure. I hope…I assume they’re doing OK today, right? STEPHANIE: Yes, yes. Everybody’s doing very well today… DR. LEE: Excellent. Excellent. STEPHANIE: which I think is why I’m so personally‚…my personal opinion is that your products are wonderful and, you know, things being what they were then versus now, I would definitely advocate for 100% human milk diet and advocate for this if I was a parent in the NICU now. So I think it’s great to get this information out to people. DR. LEE: Sure. Absolutely. So your question concerned the type of studies we did. Well, as I said to begin our conversation, we recognized that the only way that people‚…the medical community, both neonatologists, nurses, lactation people‚…would appreciate and realize the importance of what 100% human milk diet does and helps as far as the baby is concerned is to do proper research. As I said earlier, my experience is in the pharmaceutical and biotech industries where doing formal randomized controlled all the kinds of bells and whistles that need to be done when you need to license a drug or a biologic for marketing in this country and other places in the world as well. That’s standard stuff. So when we set out to do these studies, we said what we’re doing here is just as important, just as the need for rigor has to be here as it would be in any other kind of situation where you’re testing a new medical intervention. And that’s what this is. So we decided right off the bat we would get together the best of the best as far as the neonatologists in this country are concerned, and we brought them together and we set up a protocol. And basically the protocol was based on a very simple premise. It is 100% human milk diet better than feeding a baby mom’s milk fortifying then with standard human milk fortifier and then if all else fails or at least maybe not be sufficient than using formula. That’s standard practice for premature infants in this country. It was in 2007 when we started this trial and to a large extent it still is today. So it’s 100% human milk diet standard of care which includes cow’s milk based fortifier and formula. Babies in this study were randomized which is‚…you know, it’s a fairly simple term, but just to make sure everybody understands what I mean by that, the decision when a parent agreed to have their baby be participating in the study which group they get into, the Prolacta or the 100% diet versus standard of care was essentially a coin flip, not literally of course, but that’s the basis. Now why do you do that? Because that’s the best way to design studies. It provides an unbiased approach to making the decision of treatment of nutritional treatment, taking it out of the hands of anybody and putting it in the hands of strictly chance. So you randomize babies. There was a sufficient number of babies in the first study we did. There was over 200 babies that were randomized and I think it was 12 centers around the country. And what we were looking for in this study was whether or not they develop NEC and that was the most significant endpoint of the study. There were other things that we looked at. We looked at how much parenteral nutrition they received. We looked at other things. We looked at sepsis. We looked at‚…which is essentially bacterial infection that circulates in the bloodstream. We looked at hospital days. We looked at days on a respirator/ventilator and so on and so forth. But the main endpoint in this study was Necrotizing Enterocolitis. Now, the babies, by the way, that we used in this study or the babies that constituted the population of the study were babies under 1250 grams (2 pounds 12 ounces) down to 500 grams (1 pound 1 ounce). Very simple reason for that. I think many of the people listening will know that there’s a classification of premature infancy called very low birth weight. And that’s babies under 1500 grams (3 pounds 4.91 ounces). But we said, you know, we want to get the babies that have the highest risk of NEC. So we didn’t use, if you will, the heaviest babies in that weight category because they have, it turns out, the lowest risk of NEC out of all very low birth weight babies. So we took away that 1250-gram group. We also didn’t go below 500 grams because unfortunately, babies born less than 500 grams which is really about a pound or less have unfortunately not a high chance of either succeeding in life really and survival or they have a lot of other problems that make it very difficult to evaluate then. So it was 500 to 1250. That’s basically, I think, the most important aspect. And like I said, they were randomized. We followed them for a period of 90 days, maximum 90 days. Babies could have gotten off the study earlier if they got on to mostly oral nutrition which of course hopefully babies all do because they start off with what’s called parenteral nutrition which means they get their feed essentially through intravenous feeding. They then transition off of that onto enteral feeding which is typically a tube that goes either through their nose or directly through their mouth into their stomach. And that’s called enteral feeding. And then they go to oral feeding. So babies who are on for 90 days or if they got to oral feeding sooner, then they were off the study. Very simply, just to summarize what constitutes a fairly complex study to manage, we found a magnificent reduction in Necrotizing Enterocolitis. The babies in the standard of care group had a NEC rate of about 16%. Or put simply, that one in every six babies develop NEC that got some sort of cow’s milk protein or cow’s milk diet. The babies who got 100% diet was less than 6%. That 16 to 6 is about 70% reduction, and that is phenomenal. We’ve had some of the really very famous neonatologists told us that they don’t see‚…you don’t see that kind of reduction with really any intervention that they’re used to seeing. You just don’t see that. You see incremental things. But now all of a sudden we cut NEC by 70% by doing this. And it even gets more impressive when you consider that the majority of babies or at least half the babies who develop NEC have to go on to have surgery. STEPHANIE: Right. DR. LEE: And that is a really serious consequence not only just from the fact that a premature infant has to go on to major surgery and they take out part of their digestive tract. But even worse, they have a reasonably high mortality rate. So in this study, the rate of NEC surgery of all those babies that were in the two groups, it was at 11% in the standard of care arm and only just over 1% in the Prolacta arm. We reduced the rate of NEC surgery by eight fold, I mean just an incredible difference. Virtually wiped out NEC surgery in this study. STEPHANIE: That’s amazing. DR. LEE: Yeah. I mean, we expected to see something really good. We didn’t expect‚…I guess you could say well we should have expected‚…but it was beyond our expectations, wildest dreams to show this kind of effect. Now a lot of people have looked at this data and said well that’s interesting, and maybe that’s real. But can you‚…you know, can you do it again? And the answer is yeah. We did it again because that first study that I just described, these were only babies who were getting‚… which are most babies‚… who were getting some breast milk from their mom. But there are a small cohort of‚… I don’t know quite what the percentage is in this country, but there’s a percentage of babies who don’t get any breast milk. There’s various reasons. Mom is sick. Mom’s not available. So on and so forth. So we also did a second study in which we only treated babies or fed babies who had to get their nutrition either one of two ways. Since breast milk wasn’t available, they got formula. Soon as they were able to get enteral feeding, in other words the tube feeding, they got formula. That’s one group. The 100% arm, same thing, except here, instead of getting mom’s milk, they got donor milk, and then they got the fortified. So it was a real stark comparison. Only human milk, only formula. And it was a very small study. It was only‚…that first study, I don’t know if I mentioned or made clear, that was a 200-baby study. Pretty big study. STEPHANIE: Yes. Um-hmm. DR LEE: This study was only 53 babies partly because it was very, very hard to find these babies. I mean, we would sign up a mom, they would agree to put their baby on, and then they realized gee, I really want to feed my baby. I really want to give them breast milk. And of course, that’s fine. That’s great. STEPHANIE: Right, right. DR LEE: But they can’t participate in the study. STEPHANIE: Right. DR LEE: So we had a hard time finding. But we eventually did it. Took us three years to find 53 babies, but we did, and you know what? We found the same significant difference, particularly in the surgical NEC. There were‚…in the control arm, there were 24 babies, and four of them had to go on to surgery for NEC. That’s one in six. So about 16%. In the Prolacta arm, in the 100% milk arm, nothing, no surgeries, nothing. One case in NEC overall, but no surgery. So that turned out to be wow. That’s the kicker. Two separate studies, two different classes of babies, breast milk, no breast milk, doesn’t matter. When you give a baby that’s born premature like this, this weight category, less than 1250 grams, and you feed them with only human milk, they’re going to do better. And it even turns out when you start putting all the data together an extra‚…I hate to call it a bonus‚…but an extra important key outcome was that mortality was reduced. Mortality fortunately in this baby population is pretty low. It’s about 8% overall because of the prematurity, of course. We reduced that to 2%. So a four-fold reduction in mortality. So now when you put it all together, what do you have? You have prevention of the major morbidity‚…that is NEC‚…of prematurity, and you prevent mortality. And how can you really ask for anything more from a nutritional approach to these really fragile infants. STEPHANIE: Right. Right. No, I totally agree. And as I said before, my personal opinion, you know, as the mother of a surgical NEC survivor, I would advocate for this if we had to do it again. It’s definitely phenomenal. DR. LEE: Yeah, it’s almost this kind of effect you would expect to see if this was a pharmaceutical breakthrough or some new wonder drug or some sort of biotechnologically-produced intervention. But all it is is feeding the babies properly. I mean it’s such a fundamentally sound, logical‚…this is what nature wanted these babies to get. STEPHANIE: Right, right. DR. LEE: Babies should get human milk, nothing else. STEPHANIE: Now you had mentioned previously the difference between donor milk and then your human milk nutritional products. Can you‚…when I hear conversations, I sort of always think it’s like comparing apples and oranges. You know, it’s almost two different things. So can you clarify what the difference is with donor milk and your products? DR. LEE: Well, again, I’m sorry to be maybe not entirely clear. We make a donor milk product. Essentially, all our products are made from donor milk, both the fortifier, of course, and we make a simple donor milk product that is formulated to have 20 calories per ounce which is what doctors and nurses and dieticians believe they’re giving the baby when they feed the baby either mom’s milk or milk from another person. So donor milk is essentially the equivalent of mom’s milk other than the fact, of course, it comes from another mom. But however‚…and in fact, the American Academy of Pediatrics has said the best thing for a baby is mom’s milk. But if mom’s milk is not available, then donor milk is good. STEPHANIE: Right. DR. LEE: But the problem, of course, and one of the I guess you could say‚…I’m trying to think of the right word. Bad things that people associate with donor milk is well it comes from somebody else, and how do I know that person is the right person to provide milk for my baby? And that’s one of the key things that we had at the center of what we did at Prolacta from the beginning, which was to have a safety profile that was beyond reproach. I mean, we do things as far as testing the moms, testing the milk, that nobody else who ever handles breast milk does pure and simple. I’ll give you some examples. One of the things that I thought of very early on is because, again, remember I told you I came from the blood industry and they test blood and they test donors obviously every which way you can think of. But there’s one additional problem that donors who provide milk have in a sense that blood donors don’t. When you take blood from a donor, you’re seeing the person and it’s blood coming out of their vein and it’s coming right into a bag and you know whose it is. But a milk donor, she donates at home, pumps at home, puts it into containers, and then sends it wherever the donor, the milk bank, might be. In our case, it’s here at Prolacta. They’ll send it to us, and here’s the problem. How do we know it’s that person’s milk? STEPHANIE: Right. DR. LEE: How do we know it’s the person who we screened and did all the blood testing on to start with, that it’s her milk. So we do something very, very unique. We actually have the mom provide a DNA sample, they do a little cheek swab, they put a little stick essentially in there, and scrape off a little tissue from inside their cheek, send it to us so we have a profile. Now she sends us her milk, and when she sends us her milk, we can actually match it up. And now we know it’s that safe mom’s milk, all right? Now you might ask what’s the point? I mean what self-respecting individual is going to send somebody else’s milk to you? And the answer is nobody, for the most part I can say almost universally, will do that intentionally. But there are mistakes. I mean one of the things we’ve seen is moms that are lactating, sometimes there’s a couple of women in a neighborhood, and they’re all doing the same thing. And somebody’s freezer will become full with milk, and they’ll say to their neighbor, “Can I put my milk in your freezer?” And they said, “Sure, no problem.” And she’s got her own milk in there. And then they go to ship milk and lo and behold, there’s somebody else’s in there. We love that‚…we love the moms, but we have to be sure that every mom that donates is a mom that’s free of all of the nasty things that could be in blood because those things could be in milk as well like AIDS and hepatitis and syphilis and all those kinds of things that we should be concerned about. Even as an adult you certainly want to get blood from someone like that. You certainly don’t want to give that to this fragile premature infant. STEPHANIE: Right, right. DR. LEE: So going back to your original question about what we do versus donor milk, that’s all one in the same, I think you could safely say. Everything is based on the concept of donors and the milk that they provide and the safety of that milk supply being tested from any way you can think of so that every product that’s made from human milk is as safe as possible based on all of the different protocols that are used. And that includes other things besides DNA testing. It includes drug testing; it includes testing for whether the mom smokes because they may tell you they don’t smoke, but we’ve seen that instance where there’s byproducts of nicotine in the milk, and that’s not good for a baby. So we do that kind of testing. It’s just a laundry list of things to make that as safe as possible. STEPHANIE: Right. And I guess‚…I’m sorry‚…I guess to clarify my original question, I was speaking specifically about your fortifiers versus human milk. If you could explain a little bit the difference of that‚…I mean this was a very good‚…I can’t think of the word‚…a very good deviation, but yeah. When I was saying apples and oranges, I meant donor milk versus fortifier. DR. LEE: OK. I’m sorry. STEPHANIE: No, that’s OK. DR. LEE: The fortifier essentially‚…if you want to keep it very simple, the fortifier is just very concentrated milk. STEPHANIE: OK. DR. LEE: So essentially, what you do to make the fortifier is you take milk, you filter it to get rid of a lot of the fluid so that you concentrate the protein, you concentrate some of the other important nutrients in there. And that way the baby can get extra, like we say, protein, extra other nutrients in a very, very small volume. So for example, in our typical fortifier which we call Prolact +4, if you add that to mother’s milk in a ratio 80% mother’s milk to 20% fortifier, assuming mother’s milk is about 20 calories per ounce, you’re going to add 4 additional calories for that baby in that small volume which is a lot. So then we can actually do even more than that. We can do a +6, six calories, we can do +8 and even +10. That kind of product is for the babies that are the most fluid restricted. They can get 30 calories per ounce in the same volume that milk that originally was 20 calories per ounce was. So that’s really important for those babies, for example, that have heart defects who can’t take in a lot of fluid or babies for whatever reason are fluid restricted. STEPHANIE: OK. Thank you. DR. LEE: Sure. STEPHANIE: Yeah, that was‚… I think it’s important for parents and family members that might be in the NICU to be able to have a conversation with their doctor and fully understand what’s being given to their baby and be able to ask the right questions. So would there be anything else that you would want to add if you were talking to a parent who’s got a baby in the NICU right now for them to be able to advocate best practices for their baby? DR. LEE: I think that the simple issue for a parent under these circumstances is to ask the doctor based on all of the evidence that’s out there, clinical evidence,…and that’s how doctors make decisions. We talk about evidence-based medicine. This is based on the best evidence that the doctor is aware of, what’s the best way to feed my baby? And having said that, you know, the evidence that we’ve discussed here today is for those smallest of the small. For a larger baby, this is not necessarily‚…it’s not that it’s wrong. It may not be necessary, but when you’re dealing with the smallest babies and the ones that are struggling to survive and grow and thrive and get to where you want all babies to get to, to childhood and so on, then you have to ask the doctor the question what is the best way that our baby can get out of that NICU, that Neonatal Intensive Care Unit, and get home and be with his or her parents. That’s really, I think, the fundamental question. And the doctors should be able to answer that question based on the evidence that exists for the diet that the baby should be fed. STEPHANIE: Right. Thank you. Yeah, I think this is a really great conversation for any parent in the NICU, especially those, like you said, the smallest that are at the highest risk for developing NEC and as you said, other issues as well. And it’s‚…it can only be a benefit in my opinion. DR. LEE: Absolutely. And just to add to that, they should also ask the question‚…because there are other sources of nutrition, and there are other places from which milk can be attained we know about, for instance, women sharing milk on the Internet, milk sharing sites. You’ve got to be extremely careful. You’ve got to ask the question not only what’s best for my baby from the point of view of effectiveness, but also what’s the safest for my baby. And you want to be sure that the source, where that milk is coming from, where those products are coming from, comes from a place where you can say everything possible based on modern technology has been done to protect that milk, protect the safety of that milk. And I think that’s really critical. I think there was a story the other day‚…I forget which show, where it came up in one newspaper or another‚…about‚…oh, I know what it was. It was an article that was published that basically looked at milk samples. They actually collected milk on one of these sharing sites, and they found a large percentage of them had nicotine in the milk, had other things, other bad things that you don’t want a baby to have in that milk. So you’ve really got to ask that question what’s the best? What’s the safest for my baby as well? STEPHANIE: Right. Right. And Prolacta has provided us some material, some reference materials for sharing. So I will say that we’re going to be posting those on our website and will have them in the show notes as well. And I really appreciate you taking the time to talk to me today. If there’s anything else at all that you would like to add, please feel free. DR. LEE: Well, I just want to thank you for the opportunity to let obviously the parents out there know that we’re here for one very, very simple reason. I mean I know it may sound kind of corny, but we said from the day we opened the doors at Prolacta that we’re here to save babies, and I think we’ve done our job in that regard. And we’ve proven that that’s the case. So I’m really‚…I’ve worked, as you heard me say, for 35 years doing clinical and medical research, and I’m very, very proud to say that this is, I think, my best story to tell out of all that long career. STEPHANIE: Right. And as I said, I was out in the facility, took the tour in November, and we were very impressed with your company. And like I said, if I had to do it all over again, I would certainly be asking these questions and in my opinion, I think this is a phenomenal company. And your rigor in testing and your facility are top notch. So thank you. LEE: Well, thank you. Thank you. I really appreciate that, and it means an awful lot to me and to obviously everybody that works at Prolacta. STEPHANIE: Right. So thank you for joining us. And hopefully we’ll talk again soon. LEE: Alright. Thanks so much, Steph. STEPHANIE: In closing, I’d like to share a few thoughts about today’s conversation with Dr. Lee. Recently, I’ve seen a lot written about the use of donor milk, human milk products, and the emerging breast milk industry. Often times, the opinions expressed about Prolacta are solely related to cost: the expensive of Prolacta’s products versus those coming from nonprofit donor milk banks. In my opinion, the cost of using Prolacta’s human milk-based human milk fortifier far outweighs the potential risks of not using it, and any discussion about cost needs to be framed within the context of total cost of care. As Dr. Lee mentioned, Prolacta’s human milk-based nutritional products are intended for extremely premature infants who weigh less than 1250 grams (2 pounds 12 ounces) at birth. My son Morgan weighed 2 pounds 5.5 ounces at birth; my son Shaymus weighed 2 pounds 7 ounces. Prolacta openly shares that the typical cost of using their human milk-based human milk fortifier for these babies is $10,000. That, however, is only a fraction of Morgan’s and Shaymus’ total cost of care. Each of whose exceeded $1 million. In actual numbers, the cost of an exclusive human milk diet using Prolacta’s human milk-based human milk fortifier would have been less than one percent of Morgan’s total cost of care, and less than one percent of Shaymus’ total cost of care. And while Morgan’s case shows that no current preventative strategy for NEC is 100% effective, research shows that access to, and the use of, an exclusive human milk diet significantly reduces the risk of NEC in the majority of extremely premature infants. Show your support for our smallest and most fragile babies, those who have the greatest risk for developing NEC. Show your support for continued research in NEC. And join our effort to raise awareness about, and funds for research in NEC by making a donation to Morgan’s Fund at morgansfund.org. If you’ve had a personal experience with NEC and would like to share your story, or have a question or topic that you’d like to hear addressed on our show, e-mail us at feedback@morgansfund.org. We’d love to hear from you! Additional resources: Prolacta Bioscience, Inc. What Is Necrotizing Enterocolitis? N.p.: Prolacta Bioscience, 2015. Print. Prolacta Bioscience, Inc. 100% Human Milk: The Best Nutrition. N.p.: Prolacta Bioscience, 2014. Print. Prolacta Bioscience, Inc. Nutrition for Premature Babies. N.p.: Prolacta Bioscience, 2014. Print. Prolacta Bioscience. Premature Babies: What to Expect. N.p.: Prolacta Bioscience, 2014. Print. Copyright © 2015 The Morgan Leary Vaughan Fund, Inc. The opinions expressed in Speaking of NEC: Necrotizing Enterocolitis (the Podcast series) and by The Morgan Leary Vaughan Fund are published for educational and informational purposes only, and are not intended as a diagnosis, treatment or as a substitute for professional medical advice, diagnosis and treatment. Please consult a local physician or other health care professional for your specific health care and/or medical needs or concerns. The Podcast series does not endorse or recommend any commercial products, medical treatments, pharmaceuticals, brand names, processes, or services, or the use of any trade, firm, or corporation name is for the information and education of the viewing public, and the mention of any of the above on the Site does not constitute an endorsement, recommendation, or favoring by The Morgan Leary Vaughan Fund.

  Episode 2 features Dr. Adam Matson, attending neonatologist at Connecticut Children’s Medical Center-Newborn Intensive Care Unit (Hartford, CT) and Assistant Professor of Pediatrics and Immunology at the University of Connecticut School of Medicine (Farmington, CT). During this episode, Dr. Matson provides a comprehensive overview of NEC as it relates primarily to very low birth weight babies, those weighing less than 1500 grams (3 pounds 4.91 ounces) and who have the greatest risk for developing the disease. He discusses: * The early warning signs of NEC, what steps are taken when NEC is suspected, and how X-rays are used to diagnose NEC * How a premature baby’s immune response to the microbiome (bacterial communities) of the intestine appears to play a role in the development of NEC * Known risk factors of NEC, and how they may affect the intestinal microbiome * His current research focused on innate immune signaling in the developing intestine as it pertains to the development of NEC * Current prevention strategies for NEC * Additional research trends in NEC, and the importance of efforts to prevent prematurity Copyright © 2015 The Morgan Leary Vaughan Fund, Inc. This episode was produced in part by the TeacherCast Educational Broadcasting Network. [powerpress] STEPHANIE VAUGHAN, HOST: Welcome to Episode 2 of Speaking of NEC—a free, audio podcast series about Necrotizing Enterocolitis. Produced by The Morgan Leary Vaughan Fund, and funded by The Petit Family Foundation, Speaking of NEC is a series of one-on-one conversations with relevant NEC experts—neonatologists, clinicians and researchers—that highlights current prevention, diagnosis, and treatment strategies for NEC, and the search for a cure. For more information about this podcast series or The Morgan Leary Vaughan Fund, visit our website at morgansfund.org. Hello, my name is Stephanie Vaughan. Welcome to the show. I’m the Co-founder and President of The Morgan Leary Vaughan Fund. Today, my guest will be Dr. Adam Matson, attending neonatologist at Connecticut Children’s Medical Center-Newborn Intensive Care Unit in Hartford, CT, and the Assistant Professor of Pediatrics and Immunology at the University of Connecticut School of Medicine in Farmington, CT. Dr. Matson will share with me today a comprehensive overview of NEC as it relates primarily to very low birth weight babies, those weighing less than 1500 grams or 3 pounds 4.91 ounces, who have the greatest risk for developing the disease. During our conversation, he will discuss in varying degrees: Early warning signs, Steps that are taken when NEC is suspected, Diagnosis, Risk factors, Prevention, Current areas of research, and The importance of efforts to prevent prematurity He will also discuss how a premature baby’s immune response to the microbiome or bacterial communities of the intestine appears to play a role in the development of NEC, and his current research focused on innate immune signaling in the developing intestine as it pertains to the development of NEC. With that in mind, let me introduce my guest today. Welcome, Dr. Matson, thank you for joining us today. I’m very excited to talk to you. DR. ADAM MATSON, GUEST: Thanks for having me here. STEPHANIE: As you know, we’re talking about Necrotizing Enterocolitis, but I’d love for you to tell me about your experience in the NICU and then in the NICU in relation to your experience with NEC. DR. MATSON: Okay, well, I am an attending neonatologist at Connecticut Children’s Medical Center, which is located in Hartford, Connecticut, and there I’m involved with taking care of premature babies and infants with other types of medical problems. And unfortunately, Necrotizing Enterocolitis is one of the disease processes that does affect premature babies in our unit as like many other NICUs around the world. In our NICU, we average probably about 14 cases of Necrotizing Enterocolitis, or I’ll refer to it as NEC, per year, so it’s a major medical problem for these infants. As I mentioned before, it’s unfortunate that I do have experience in managing these infants. STEPHANIE: So what can you tell me as a parent about I guess signs and symptoms and what you guys as the doctors and clinicians and nurses are looking for that’s, I guess raises a red flag for you that this baby might have NEC? DR. MATSON: Sure, so NEC is most common in the very small premature babies, particularly those that are with birth weights less than 1500 grams (3 pounds 4.91 ounces). So these are infants that are typically being fed by a feeding tube that’s introduced into the nose and goes down to the stomach, or into the mouth and goes down to the stomach. Usually these babies are too small or weak to eat on their own. And it’s a gradual process. We start with small volumes of feeds and increase them gradually. And the types of symptoms that babies can start to develop when this process begins can sometimes be nonspecific. They can have decreased activity, they may have increased apnea spells (moments when the baby stops breathing) is something that we’ll see. Their abdomens can become more distended. One of the things that we’ll frequently check for are something that is referred to as aspirates. This is when a nurse is going to give a feed with feeds being given every three hours. They will check the stomach to see how much of the prior feed has actually gone out of the stomach and into the intestines. So often times if the intestine is starting to not feel too happy, that feed can sort of back up and that’s called an aspirate. If the volume becomes excessive, one of the measurements that we’ll use in our unit is more than 50% of the prior feed, that’s a red flag for us. STEPHANIE: Okay, actually that was the first symptom that Morgan had was his aspirate they said was tinge green which was an immediate red flag and x-rays were taken bedside and that’s—rapidly they discovered that he had NEC and that’s when he had his surgery. So that was definitely a red flag with him. DR. MATSON: Sure, those signs occur particularly when the aspirate turns green, as you had mentioned for your son that indicates that bile that’s being emptied into the intestine is not emptying down into the more distal portions of the intestines. So for his bile to start backing up, that’s absolutely a warning sign. STEPHANIE: Okay, thank you. So is there anything else that would be a good warning for parents or questions that they should ask if something’s maybe not looking right? DR. MATSON: Well, as I had mentioned, many of the signs can be nonspecific and they can actually often occur very fast as well. You know, we do monitor as I had mentioned for those things, bloody stools as well. And if those sort of warning signs come up, typically we’ll end up holding some feeds for a while to not overwhelm the stomach or the intestine with additional food, and as you had mentioned, we’ll end up doing x-rays and that’s the primary way that Necrotizing Enterocolitis is diagnosed. Really what we’re looking for with those x-rays is a finding referred to as pneumatosis intestinalis. And what that is is part of the pathophysiology of NEC is as bacteria are starting to invade through the intestinal wall, they can start to produce gas and make gas bubbles, and when we do x-rays looking for NEC, if we visualize those gas bubbles in the walls of the intestine, that’s diagnostic that the process is indeed happening. STEPHANIE: Okay, so can you tell me a little bit on the flip side of your experience with NEC on the research side? DR. MATSON: Sure, you know, perhaps I should talk a little bit about in that regard on what we think actually causes NEC. And I think that the answer to that right now is that we don’t know exactly. But it appears to be a rather complex interaction between bacteria that are inside the intestine, and exaggerated or overactive immune response that’s happening inside the intestine. The whole hypoxia or decrease in oxygen within the intestine also probably plays a role in some cases. But studies have indicated at least in many cases of NEC it’s not—it doesn’t appear to be attributable to a single bacterial species like E. coli or Salmonella. But it appears to be more related to bacterial communities or what we would say is the microbiome of the intestine which can be influenced by certain things that we know to be risk factors for Necrotizing Enterocolitis as well such as formula feeding, where breast milk—human milk is protective, excessive use of antibiotics, antacids, those sorts of things are thought to disrupt the microbiome and result in overgrowth of different species, particularly gram negative bacteria. And when there’s an overgrowth of those types of bacteria in the intestine, those appear to activate certain receptors that are inside the intestine— this is getting into a little bit of the research that I’m involved with, because these receptors primarily in premature infancy appear to be very sensitive to a large number of these gram negative bacteria, and as they start to become activated, they start to break down the intestinal epithelial lining and this results in trans-location of bacteria through the intestinal mucosa—the protective barrier, and then activation of immune cells in the deeper layers. Another feature of the premature infant is that they’re really not able to control that immune response in their intestine very well, so they end up with a very profound inflammatory response in their intestine. That’s really what Necrotizing Enterocolitis is. It’s the most common gastrointestinal emergency in premature babies. It occurs primarily in premature infants. It’s characterized by diffuse inflammation and necrosis, or tissue death inside the intestine. And it’s also associated with very significant morbidity and mortality. About 15 to 30 percent of infants who develop NEC may ultimately die. So it’s a major problem for this population. STEPHANIE: And can you tell me, I guess a little bit more about what the hospital’s doing in their research? And more specifically, what other areas you’re researching? DR. MATSON: Sure, so our hospital, we have a number of different projects that we’re involved in. We have a very active lactation program where we’re looking at different aspects of human milk. I had mentioned before that one of the main risk factors for Necrotizing Enterocolitis is diet and formula feeding, and we do know that providing human milk reduces the risk of NEC by about 50 to 90 percent providing a diet of exclusive human milk. So we are currently looking at factors inside of breast milk, macronutrients and how they affect the bacterial populations inside of the intestine and how that may ultimately contribute to infants developing this process. More specifically in terms of laboratory work, we’re now working with some collaborators at UConn Storrs as well and we’re doing a preemie poop project where we’re collecting a lot of fecal samples from babies inside our NICU. And we’re doing a real detailed analysis, molecular analysis where we sequence out basically all the different microbial species or bacterial species inside the intestine. And one of our hopes with this study is that we’re able to identify how diet and exposure to medications affect the bacterial populations inside the intestine, which we know has a very strong role in Necrotizing Enterocolitis. I also have a laboratory at UConn Health Center in the department of pediatrics and we’re looking a little bit deeper at some of the receptors inside the intestine. There’s a group of receptors that I refer to as toll-like receptors, and these recognize molecules that we refer to as pathogen associated molecular patterns or PAMPs. So these are the receptors that are on the surface layer of the cells that line the intestine and respond to these different bacteria. And I think this is the type of research that tying in aspects of clinical care with breast milk to knowing what’s actually growing inside the intestines in terms of bacterial populations, and then looking at more detailed molecular aspects of immune signaling inside the intestine and what’s ultimately controlling the inflammatory process. STEPHANIE: That’s very interesting. Is there anything else that you would like to add about research specifically? I know one of our major goals is to help the doctors and researchers advance research through funding. So can you talk to me a little bit about funding for research within the NEC community? DR. MATSON: Sure, well I think that one of the areas that would likely help the most is more funding to look at causes of premature birth. This continues to be a major problem in the United States and elsewhere. Up to ten to eleven percent of infants are born premature. And a significant number of those babies are the very premature infants that are at the highest risk for developing NEC. So I think that I need to mention that as really one of the primary areas because there’s a lot of different challenges that these babies face, and the more that we can prevent preterm birth, I think that would be advantageous for them. The other aspect I think would be important to look at is in terms of diagnosis or earlier diagnosis. Being able to identify which babies are starting to develop some changes in their intestine earlier. I have a colleague that I work with who often says that it’s when we’re diagnosing by x-ray, it’s almost like arriving at the crime scene after the crime has already been committed. STEPHANIE: Mm-hmm. DR. MATSON: The care that we implement at that stage is really is very supportive in terms of holding feeds, antibiotics, bringing the suction tube into the stomach, getting frequent x-rays, getting the surgeons involved to help follow the infants, and in many ways, the time that we’re diagnosing these infants at this point is the process is already much too far ahead. STEPHANIE: It’s definitely a complex disease, and I know that with Morgan, I think within a span of five hours or so he was diagnosed and in and out of surgery and in recovery, so I know that it’s a rapid time frame. But I appreciate all of the information that you shared with us today—I think you’ve given a really good perspective on causes and signs and symptoms, and if there is anything else that you’d like to add in any area for parents that might be listening to this from your perspective as a doctor talking to parents, please feel free. DR. MATSON: Sure, so I could mention just a little bit more about prevention of Necrotizing Enterocolitis. In some diseases, an ounce of prevention’s worth a pound of cure. When we’re looking at certain populations in the NICU, we often classify premature infants according to their weight. Those at highest risk of developing Necrotizing Enterocolitis are what we would refer to as very low birth weight infants, and those are less than 1500 grams at birth. STEPHANIE: And that’s about three pounds? DR. MATSON: Yes, pretty close to that. And I had mentioned efforts to prevent prematurity is a major goal, also diet. The American Academy of Pediatrics came out with a statement in 2012 really encouraging the provision of human milk to all of these babies. We do know that human milk does help protect against Necrotizing Enterocolitis. And if mom’s milk is not available for these infants, many units including ours are now using pasteurized donor human milk. It’s a very safe product, and that has been shown to help as well. Other potential preventative measures is—one would be using a standardized feeding protocol. There is very good data on that. That means really sort of having a very strict protocol for each size baby and how much milk you start with with the feeds, how rapidly you advance them, and what sort of warning signs that the healthcare team should be observing for. So that has been shown to be very important. Limited use of antibiotics appears to be very important. It’s a difficult task for us while we’re inside the Newborn Intensive Care Unit because these babies are at such high risk for infection. But one of the things that data has shown is that the more antibiotics, the more unnecessary antibiotics, that these babies receive increases their chances of getting Necrotizing Enterocolitis, so that probably relates to overgrowth of gram negative and other bacteria inside the intestine that activate the inflammatory cascade. There’s a few interesting other preventative measures that are topics of conversation within our field and one is using probiotics. There is good data out of other countries. So, I should say that probiotics are live bacteria. They’ve been using older children and adults for some time for various reasons. Bifidobacterium and Lactobacillus are the most common probiotics. Those are bacteria that are typically found in the stool of breastfed infants. And many units outside of the United States are now giving these probiotics, which they’re giving them to extremely premature infants in an effort to prevent NEC from happening. And the thought is that these help to prevent some of the pathogenic bacteria from growing, they also help to mature the intestinal barrier inside the intestine. At this point in time in the United States, however, there has not been a—at least to my knowledge—there has not been a properly randomized, controlled trial to study these here. And also another major issue using probiotics in the United States is how are they regulated by the FDA as they’re considered a food. So really you can go to GNC or CVS to buy probiotics over the counter. So with that type of designation by the FDA, they don’t have the same oversight as a drug would, and one of the concerns with many of the NICUs in using a product like that is it doesn’t have the same consistent quality oversight, meaning that we don’t know how pure it is or how consistent the actual dose would be that we’re giving to premature infants, so hopefully some research down the line will help answer those questions. STEPHANIE: Well, I think you’ve given us a lot of information, a lot of really good information I think, and a lot of really relevant information for parents that will be listening. So I really appreciate you sharing your time with us, and joining us today. And so with that, I will let you go. And… DR. MATSON: Okay, well thank you very much. STEPHANIE: we will talk again. DR. MATSON: Sounds great. STEPHANIE: Thank you. DR. MATSON: Okay, take care Steph. STEPHANIE: Thank you. STEPHANIE: For more information about Dr. Matson and his research in NEC, visit: connecticutchildrens.org. A direct link can also be found in this episode’s show notes: http://www.connecticutchildrensfoundation.org/document.doc?id=402 In closing, I’d like to share a few thoughts about today’s conversation with Dr. Matson. One of Morgan’s former doctors described NEC to me as “an inflammatory response gone haywire.” That simple, but vividly descriptive, phrase gave me pretty quick understanding of the disease that nearly took my son’s life. The inability of a very premature baby to regulate their immune response, and in turn their inflammatory response, appears to be a crucial factor in the development of NEC. And as Dr. Matson mentioned, understanding not only how diet and exposure to medications affect the bacterial populations inside the intestine, but also understanding the immune signaling inside the intestine and what’s ultimately controlling the inflammatory process are critical to fully understanding, and preventing, NEC. Show your support for our smallest and most fragile babies, those who have the greatest risk for developing NEC. Show your support for continued research in NEC. And join our effort to raise awareness about, and funds for research in NEC by making a donation to Morgan’s Fund at morgansfund.org/donate. If you’ve had a personal experience with NEC and would like to share your story, or have a question or topic that you’d like to hear addressed on our show, e-mail us at feedback@morgansfund.org. We’d love to hear from you! Additional Information You can make a donation directly to Dr. Matson’s research in NEC at Connectiut Children’s Medical Center by visiting https://www.connecticutchildrensfoundation.org/giving/nec Copyright © 2015 The Morgan Leary Vaughan Fund, Inc. The opinions expressed in Speaking of NEC: Necrotizing Enterocolitis (the Podcast series) and by The Morgan Leary Vaughan Fund are published for educational and informational purposes only, and are not intended as a diagnosis, treatment or as a substitute for professional medical advice, diagnosis and treatment. Please consult a local physician or other health care professional for your specific health care and/or medical needs or concerns. The Podcast series does not endorse or recommend any commercial products, medical treatments, pharmaceuticals, brand names, processes, or services, or the use of any trade, firm, or corporation name is for the information and education of the viewing public, and the mention of any of the above on the Site does not constitute an endorsement, recommendation, or favoring by The Morgan Leary Vaughan Fund.

Stephanie shares how her son Morgan’s experience with Necrotizing Enterocolitis was the catalyst for not only founding The Morgan Leary Vaughan Fund but also developing and producing the Speaking of NEC: Necrotizing Enterocolitis series. Copyright © 2015 The Morgan Leary Vaughan Fund, Inc. Welcome to Speaking of NEC: Necrotizing Enterocolitis—a free, audio podcast series about Necrotizing Enterocolitis or NEC. Produced by The Morgan Leary Vaughan Fund, and funded by The Petit Family Foundation, Speaking of NEC is a series of one-on-one conversations with relevant NEC experts—neonatologists, clinicians and researchers—that highlights current prevention, diagnosis, and treatment strategies for NEC, and the search for a cure. For more information about this podcast series or The Morgan Leary Vaughan Fund, visit our website at www.morgansfund.org Hello, my name is Stephanie Vaughan. I’m the Co-founder and President of The Morgan Leary Vaughan Fund. Welcome to our show. As a prologue to this series, I would like share with you a little bit about Necrotizing Enterocolitis, and how my son Morgan’s experience with NEC led our family to found a public charity dedicated to NEC, and in turn, develop and produce Speaking of NEC as our charity’s cornerstone educational initiative. My twin sons Shaymus and Morgan were born on October 29, 2010 at 28 weeks, one day gestation—nearly three months early— each weighing less than 2.5 pounds. At 4 days old, Morgan had to be transferred to Yale-New Haven Children’s Hospital when the doctors at Bridgeport Hospital suspected that he had developed Necrotizing Enterocolitis or NEC, an inflammatory disease that leads to necrosis or death of the intestine. Shaymus remained at Bridgeport Hospital. NEC is predominately due to prematurity and its statistics are startling: NEC is the second leading cause of death in premature infants. NEC is the 10th leading cause of infant death overall. In the United States alone, NEC occurs in approximately 25,000 babies per year. All newborn infants born preterm (before 37 weeks of pregnancy) or born with a low birth weight (less than about 5.5 pounds) are at increased risk for NEC. The smaller the infant or the more premature the delivery, the greater the risk. For very low birth weight babies like Morgan, who weigh less than about 3 pounds, the chance of developing NEC is approximately 1 in 18, and Infants with the most serious form of NEC have a 1 in 4 chance of dying. (Sources: UC Davis Health System, CDC/NCHS, APSA and NICHD.) Recently, one of the doctors at Bridgeport Hospital described NEC to me as “an inflammatory response gone haywire.” Once at Yale, Morgan underwent emergency surgery. He had one perforation in his small intestine, and five smaller areas that were about to perforate. Approximately eight inches of his small intestine were resected or removed. For his age and size, that was equal to approximately 20% of his small intestine. Immediately after Morgan’s surgery, the surgeon came into the waiting room, sat down across from my husband and me, and began to explain how the surgery went and what we could expect for Morgan’s recovery. Morgan was “very sick,” sicker than the doctors had thought, but had tolerated the surgery well and the surgeon was optimistic about his recovery. In another 6–8 weeks, Morgan would need to have a second surgery to reconnect his intestine. One of the prerequisites for the anastomosis or reconnection surgery was for Morgan to weigh at least two kilograms (4 lbs., 6.5 oz). Morgan would need to double his birth weight before the surgeon would consider operating on him again. In the interim, he would have an ostomy pouch to collect eliminated stool and gas. We felt an overwhelming sense of relief when his surgeon performed a successful reconnection surgery. And we were thrilled to bring Morgan home to his brother on Valentine’s Day 2011—three weeks past his original due date. Before coming home, Shaymus spent 85 days in the Newborn Intensive Care Unit at Bridgeport Hospital; Morgan spent a combined 109 days in the Newborn Intensive Care Unit at Bridgeport Hospital and the Newborn Special Care Unit at Yale-New Haven Children’s Hospital. They are now happy, healthy four-year-olds. Because of Morgan’s and our experience, our family founded The Morgan Leary Vaughan Fund (Morgan’s Fund)—an all-volunteer, public charity dedicated to Necrotizing Enterocolitis. Our mission is to promote public awareness about NEC and the potentially devastating effects it can have on preemies and their families, and to advance research to prevent, diagnose, treat, and ultimately, cure NEC. Named after Morgan, it celebrates his survival, courage and strength. We know how lucky we are that Morgan not only survived but has also thrived since his bout with NEC, and this is our family’s way of paying it forward. The Morgan Leary Vaughan Fund was incorporated on Valentine’s Day 2012. It was a wonderful way to celebrate the first anniversary of Morgan's homecoming. On June 26, 2014, we reached our first major milestone when the IRS awarded us our 501(c)(3) tax-exempt status, officially making Morgan’s Fund the first public charity dedicated to Necrotizing Enterocolitis. In December 2014, we applied for a grant from The Petit Family Foundation in Plainville, Connecticut. The project for which we applied was our cornerstone educational initiative—a free, audio podcast series about NEC. In late January 2015, we were awarded the grant funding. And today, February 28, 2015— in honor of Rare Disease Day, we are launching Speaking of NEC. Immediately after Morgan’s diagnosis four years ago, we began to research NEC and its causes and outcomes. We had questions not only about his recovery, but also about what his future would hold after he came home. We quickly learned that, for as common as this dangerous and often fatal disease is in premature babies, there was very little information about NEC available online. Our search led to more questions than answers. And the questions that kept coming up were: Why don’t more people know about NEC? What is being done to prevent NEC? Who is doing research in NEC? And, where is that research being done? It is our hope that Speaking of NEC: Necrotizing Enterocolitis provides you with some answers to those critical questions. Morgan’s Fund through its support of research, and with your help, hopes to change the lives of thousands of very low birth weight babies like Morgan, who have the greatest risk for developing NEC. To learn more about Morgan’s Fund, or make a donation, visit our website at www.morgansfund.org/donate On behalf of all of the babies like Morgan, and families like ours, who have been directly affected by NEC, thank you for listening. To more information, contact us at www.morgansfund.org/itunes Copyright © 2015 The Morgan Leary Vaughan Fund, Inc. The opinions expressed in Speaking of NEC: Necrotizing Enterocolitis (the Podcast series) and by The Morgan Leary Vaughan Fund are published for educational and informational purposes only, and are not intended as a diagnosis, treatment or as a substitute for professional medical advice, diagnosis and treatment. Please consult a local physician or other health care professional for your specific health care and/or medical needs or concerns. The Podcast series does not endorse or recommend any commercial products, medical treatments, pharmaceuticals, brand names, processes, or services, or the use of any trade, firm, or corporation name is for the information and education of the viewing public, and the mention of any of the above on the Site does not constitute an endorsement, recommendation, or favoring by The Morgan Leary Vaughan Fund.