In this episode, Dr. Jonathan Swanson discusses the evolution of neonatal nutrition and the major tenants of neonatal nutrition that have been learned over the years. He emphasizes the importance of breast milk and the role it plays in neurodevelopment and short-term outcomes. Dr. Swanson also explores the impact of necrotizing enterocolitis (NEC) on neonatal nutrition and the efforts to prevent NEC through good nutrition and optimizing homeostasis. The conversation then delves into the role of the maternal-fetal dyad in preparing the infant microbiome and the potential for probiotics to re-regulate the microbiome. The discussion concludes with a focus on the challenges and opportunities surrounding the use of probiotics in the NICU, including the role of families in decision-making and the impact of FDA regulations.
As always, feel free to send us questions, comments, or suggestions to our email: nicupodcast@gmail.com. You can also contact the show through Instagram or Twitter, @nicupodcast. Or contact Ben and Daphna directly via their Twitter profiles: @drnicu and @doctordaphnamd. The papers discussed in today's episode are listed and timestamped on the webpage linked below.
Enjoy!
In this episode, Dr. Jonathan Swanson discusses the evolution of neonatal nutrition and the major tenants of neonatal nutrition that have been learned over the years. He emphasizes the importance of breast milk and the role it plays in neurodevelopment and short-term outcomes. Dr. Swanson also explores the impact of necrotizing enterocolitis (NEC) on neonatal nutrition and the efforts to prevent NEC through good nutrition and optimizing homeostasis. The conversation then delves into the role of the maternal-fetal dyad in preparing the infant microbiome and the potential for probiotics to re-regulate the microbiome. The discussion concludes with a focus on the challenges and opportunities surrounding the use of probiotics in the NICU, including the role of families in decision-making and the impact of FDA regulations.
As always, feel free to send us questions, comments, or suggestions to our email: nicupodcast@gmail.com. You can also contact the show through Instagram or Twitter, @nicupodcast. Or contact Ben and Daphna directly via their Twitter profiles: @drnicu and @doctordaphnamd. The papers discussed in today's episode are listed and timestamped on the webpage linked below.
Enjoy!
Ben Courchia MD (00:00.986)
Hello everybody, welcome back to the incubator podcast. We are back with a new mini series about probiotics and we are recording our first episode today with none other than Jonathan Swanson. Jonathan, how are you this morning?
Jon Swanson (00:16.552)
I'm doing great. Thanks for having me here.
Ben Courchia MD (00:18.902)
No, it's a pleasure to have you on. Daphne, how's it going?
Daphna Yasova Barbeau, MD (she/her) (00:21.514)
I'm doing well. We've been looking forward to this series, especially given all the discussion around probiotics, and we're looking forward to reviewing the evidence.
Ben Courchia MD (00:33.37)
That's right.
Jon Swanson (00:33.6)
Yeah, I'm sure our questions have changed since you first reached out and now with everything going on with the FDA, so.
Daphna Yasova Barbeau, MD (she/her) (00:36.842)
Mmm. Mm-hmm. Heh heh.
Ben Courchia MD (00:41.29)
Absolutely, absolutely. I'm going to go through your bio quickly, John, just so that for people who are not familiar with your work, they can be brought up to speed. You are a professor of pediatrics at the University of Virginia. You completed your undergrad at Pepperdine University, received your MD from the University of Rochester in New York, and you completed both a pediatric and a neonatal perinatal medicine fellowship at the University of Virginia in Charlottesville. You worked in private practice for
Daphna Yasova Barbeau, MD (she/her) (00:42.358)
That's right.
Ben Courchia MD (01:10.022)
three years in New Jersey, and then you joined the faculty at UVA in 2011. You obtained a master's degree in health care quality and safety from Thomas Jefferson University in Philly in 2013. You have a master's of business administration with a concentration in health care administration from the University of Arizona in 2023. You're currently the chief quality officer for children's services and the medical director for the neonatal intensive care unit at UVA Health Children's. You have a passion.
for research that focuses on next, specifically looking at creating an improved definition for NEC and how it differs from SIP and other pathologies. Your other research interests include obviously neonatal nutrition quality improvements and cost effective care. Your bio keeps going and I'm now humbled by all the things that you've accomplished. But anyway, thank you again for being on the show and for making the time to be with us this morning.
Daphna Yasova Barbeau, MD (she/her) (01:59.105)
Yeah.
Jon Swanson (02:07.82)
Thanks for having me here. Happy to be here.
Ben Courchia MD (02:10.654)
I guess as we are embarking on this journey on trying to assess and appraise the evidence for probiotics, I think that discussion always begins at the level of neonatal nutrition. And I think it's interesting because neonatal nutrition hasn't changed very much since the beginning of time. Breast milk is still probably what we should be giving babies. And yet our understanding of...
many aspects of neonatal nutrition has evolved dramatically over the years. And I'm wondering if maybe you could walk us through a little bit what these major tenants of neonatal nutrition are that we've over the years, painfully learned, sometimes the hard way.
Jon Swanson (02:57.692)
I think you hit the highlights there. I think if we go way back, breast milk probably, most of us, at least my age, you guys are much younger than I am, were not breastfed. Formula was such an easy thing. And I think it was probably the 80s and 90s when nutrition really started focusing on breast milk again. And I think we should be thankful for that. And I think especially in the NICU,
We've definitely learned that over the last 20, 30 years, the role that human milk, especially mom's own milk, plays such an essential part in neurodevelopment, hospital outcomes, short-term outcomes. And I think that's been the key learning over the last couple of decades. Beyond that,
I think we're still trying to figure out what are the key components. I think if you look at the changes that we've seen in formula, at least over my career, all the things that the formula companies have added to the just routine infant formulas have demonstrated some of the things that we're looking at, you know, whether it be, you know, when I was a, I think intern, maybe even a little bit before that, DHA and ARA were added to formula. And then probiotics were slowly added a few late.
years later. And I don't even know if those formulas are still on the market. But I think, you know, when we look at that, I think that generally tells you, all right, these are some of the components in mom's own milk that we're trying to give to all babies, not just those in the NICU. And they obviously play an important role. And I think, you know, I'm not a basic scientist. And I can say that I'm probably not up to the
on the literature when it comes to the basic science of many of the things. But I think some of the things that we're learning about human milk oligosaccharides are so important. I think we're going to learn a lot more over the next five, 10 years about their role in not only human milk and the way that babies, you know, scratch that part, not only about human milk,
Jon Swanson (05:18.076)
but about how babies digest it, but also how it impacts long-term outcomes. I'm really excited to see that part come to fruition in the next five years or so.
Ben Courchia MD (05:24.222)
Uh-huh.
Ben Courchia MD (05:31.522)
What's interesting about this discussion is that you would be tempted to think that we are learning more and more about nutrition because we want babies to grow. Cause we know that good growth means good neurodevelopmental outcomes. But I think a lot of the lessons learned have to do with NEC. I think that we've, we've been so terrified and traumatized by this awful pathology that we've been trying every way we can to stave off NEC as much as possible. And, and then
At the end of the day, the solution to preventing NEC is good nutrition and really optimizing homeostasis, I guess. And I'm wondering if as a NEC expert, what can you tell us a little bit about that and how NEC has driven a lot of the discussion on neonatal nutrition?
Jon Swanson (06:19.06)
Okay, I'm going to go back to the first thing you said though, and that's growth. And I think as neonatologists, we're so focused on numbers and the easy number for us to look at is weight gain. Um, you know, but I think, you know, I was trained by John Catwinkel and, and several others and they ingrained in me, you know, fat babies are not necessarily healthy babies. And I think sometimes, you know, we all know that, but I think sometimes we get so focused on, well, they're not.
growing as well on mom's milk. So let's continue to push calories or things like that. But when you look at the data, they tend to do catch up in growth. And when you look at neurodevelopment, I think that's the key part. So I think we need to do better as a field looking at lean growth and really focusing on length. And our unit has the same problem. How do you get that length? How do you ingrain that into your workflow? So I just wanted to,
broach that since you broached that first. And so I guess going back to the NEC question and how it has really impacted us, I think there's a ton of things, you know, I think pediatrics had done tremendous work with their, I think it was their million babies campaign way back in the early 2000s, really focusing on all the things that can impact improvements in neonatal outcomes. And one of their major focuses was on NEC.
And so they really focused on, you know, central line utilization, reducing antibiotics. I think that group was some of the first to do that. And they've generally done, been able to show significant improvements. And so when we talk about nutrition, I think it kind of goes hand in hand. So how can we get babies off of IVs sooner? Well, part of that is going to be ensuring that they're gaining weight and maybe we can fortify earlier.
when I was an intern many years ago, we would fortify when they reached full feeds at 150 mLs per kilo. And now we're down to like 60 mLs per kilo and some units are showing excellent work even before then, even maybe even starting at a fortified mother's milk. And so I think as we learn more, learning how to improve that protein intake early on, instead of having this window where they're deficient in protein, I think is key.
Jon Swanson (08:41.844)
And at the same time, we're getting off of the, getting those central lines out even faster. So that was just one thing off the top of my head in looking at that question. I think other things, we'll get into probiotics, but really focusing on what is total, really focusing on what is the amount of...
nutrition that a baby should be receiving instead of just focusing on a number, whether it be 150 or 165 really looking at their growth. So a lot of places are now looking at more, all right, what is your Z-score? What is your grams per kilo per day? Growth instead of just focusing on one number on an individual day. I think all of those have been shown, all of those have provided an improved understanding of
infant growth within the NICU, as well as provided an opportunity for us to look at our own care practices to reduce NEC.
Daphna Yasova Barbeau, MD (she/her) (09:46.914)
You brought up an important, I think, historical point. And we have a lot of trainees who listen. And I think most of them are learning, okay, early feeding is helping us prevent NEC. But this is a pendulum swing. And you briefly alluded to that from early neonatology where we thought that feeding babies caused NEC. So maybe you could discuss that briefly. So especially our trainees and our early career neos kind of have that.
Jon Swanson (10:09.84)
Excellent point.
Daphna Yasova Barbeau, MD (she/her) (10:17.216)
mindset about why this is such an important hot topic.
Jon Swanson (10:22.444)
Yeah, I think 30 years ago, maybe even a little bit longer than that, you did not feed a baby until they were hemodynamically stable entirely. And obviously, hemodynamic instability, you're not going to feed a baby. But it took much longer to get to full feeds, even back 20 years ago when I was a resident. We would do trophic feeds for...
five, seven days, depending on the age and the size of the baby. And now we're pushing that envelope and do these babies even need trophic feeds? And I think the evidence would suggest that it isn't so much about trophic feeds, but about just making sure the gut adapts and is ready to tolerate those feeds. You know, I think some centers, you know, as an...
I'm the editor for Journal of Parental Aging. I remember one paper that came through was a center that liked to, you know, really lengthen out their feeds. And I think they went from 14 days to 28 days to get to full feeds. That's a long time in my book, but they showed a reduction in NEC. So I, I think the key here is really consistency and making sure everyone is on the same page within your unit.
Um, you know, I'm not advocating for taking 28 days to get to full feeds, but I think making sure that everyone is doing the same thing and so that we can all be on the same page within that unit is, is probably the most important. And so whether you do zero days of trophic or three days of trophic, making sure that all the nurses are doing the same thing. We're understanding each baby, but really focusing on consistency. And I think that goes into the quality improvement side of me as well.
is that consistency drives outcomes. And I think that's an important part.
Daphna Yasova Barbeau, MD (she/her) (12:23.658)
Yeah. I have a question about setting up kind of the early neonatal intestine. You wrote a paper in 2022, maternal fetal and neonatal nutrition has lifelong implications. So I'm hoping you can talk a little bit about the interplay of kind of this maternal fetal dyad and preparing the infant microbiome.
Jon Swanson (12:46.372)
Oh boy, that's a tough question. All right. All right, you're going to edit this part out, right?
Daphna Yasova Barbeau, MD (she/her) (12:53.821)
Yeah, sure.
Jon Swanson (12:55.796)
Um, all right. The maternal infant diet. I think, I think as neonatologist, we, we kind of forget about the maternal side sometimes and you know, mom's diet both prenatally and postnatally is going to affect, uh, affect the baby. I think we've all had babies that, you know, we've asked moms, Oh, maybe take a lactose out of your diet, take dairy out of your diet or, or what are you having, you know, even my wife, when we had one of our first kids who had.
Daphna Yasova Barbeau, MD (she/her) (13:03.399)
Mm-hmm.
Jon Swanson (13:24.716)
significant colic, you know, all right, we're going to change her diet and maybe improve things and things did change. And she got a little better. So I think it's important to remember that, you know, as mom is, you know, I think it's important to remember that mom's nutrition plays a key role in the not only the amount of breast milk, but what is in the breast milk. And that's going to play a role in the in the infant's
not only digestibility of that milk, but what nutrition they're pulling out. I think if you look prenatally, and a lot of times we're not part of that conversation, but the OBs are, the role of mom's nutrition in infant growth, or fetal growth, I should say, is so important. And I think that is a key interplay. Baby size, their...
how they've adapted to the intrauterine environment. I think that plays a key role in their susceptibility to NEC, the smaller the infant or SGA, IUGR status certainly has been shown to be an important factor.
Daphna Yasova Barbeau, MD (she/her) (14:35.99)
Ben, you're muted.
Ben Courchia MD (14:38.106)
John, I'm just going to ask you a quick favor. Do you mind taking your phone off your table? Cause we hear. No worries. No, no, no worries.
Jon Swanson (14:41.792)
Oh, yes, I'm sorry. I did have it on mute and silent, so I'm sorry.
Daphna Yasova Barbeau, MD (she/her) (14:43.698)
That's okay. It's a common problem. We have, it is, yeah, we can tell. That's okay.
Ben Courchia MD (14:51.286)
It's something that we struggle with because we do that as well. So I was texting Daphne on the side. I was like, is that your phone? Is that? And she's like, it's not my phone. And I'm like, oh shoot. Okay. No, we'll fix that. Um, no worries, no worries, no worries. Um, so I think I'm going to definitely any follow up question. Okay. Now can I go?
Daphna Yasova Barbeau, MD (she/her) (14:55.694)
Because it's always me, it's always my phone.
Jon Swanson (15:01.752)
Do we need to repeat that thing or we're good? Okay, all right, it's gone now, all right.
Daphna Yasova Barbeau, MD (she/her) (15:01.812)
Okay. No.
Daphna Yasova Barbeau, MD (she/her) (15:12.97)
No, I think it's, we're moving to the next phase here. You're doing great.
Ben Courchia MD (15:15.606)
Yeah, absolutely. You're doing fantastic. Yeah. Brilliant. Um, so I think to me, what's interesting is that as we, as we understand nutrition better, as we understand the relationship between mother and baby, as we understand the pathologies that are hunting these, these critically ill infants, we then understand that there's a microbiome and that there's a lot of disruption that happens and I'm just curious about, first of all, um,
Jon Swanson (15:15.985)
Am I doing okay? Am I doing okay? All right.
Ben Courchia MD (15:44.486)
what was it like to figure this out number one, and then maybe even realize that not only is this a dysregulation, but we can actually re-regulate this potentially artificially with such things as probiotics. I'm just curious what that phase of history looked like, and if you have any thoughts on how that was approached.
Jon Swanson (16:09.084)
certainly am not the one necessarily that found that out. Let's just be clear on that. And I'm not going to say I'm not an expert on the microbiome as well, but I think it's been so interesting and exciting to see what we have learned over the last 10 years about the microbiome and its effect. You know, when I give talks about NEC, you know, fairly frequently, and I think there's a few papers out there that I'm just like, really,
Ben Courchia MD (16:13.37)
fine.
Jon Swanson (16:40.38)
I don't know what word I'm looking for, but really always excited to share about. And one of them is just about, and it was from Boris Dvorak's lab in Arizona. And I used to do basic science when I was a fellow. And so that's how I was getting into that. But he has a picture of a couple of rat pups on there. And one is fed by the mom, the mother rat.
Ben Courchia MD (16:44.962)
Mm-hmm.
Jon Swanson (17:09.008)
and the other was fed a formula. And the difference just after three days of those two different types of feeds, the difference in the microvilli is so amazing to see. And just to translate that, within what's going on in our infants who we're given antibiotics to, we're putting NGs down, which are sterile, but then they're not sterile. And all the things that we're doing,
uh... to that environment were taken out of the out of the years putting them in an incubator putting them in humidity so all these things obviously are going to play a role in the bacteria that colonizes their cut uh... and then we throw in feeds on their which may or may not have uh... you know probiotics for giving moms milk certainly they'll have some but then we're giving other babies you know formula or donor human milk which likely does not
And I think all the data that has come, and that was back in the early 2000s. So all the data that has come since then about just the role that microbiome plays in our ability to change that. So one, reducing the change in the microbiome. So decreasing the number of days that we're giving antibiotics. Some great evidence from multiple places, but I know Yale had a paper that just an additional day of antibiotics from
zero to one or one to two had a significant increase in the rate of NEC. And then I think going back to Ben, your question about how can we change that and influence that is just re-providing that, re-providing the better bacteria that are going to make that microbiome and the microvilli thrive is so exciting.
I will say that as a unit, we do not use pro, we had not been using probiotics as a routine, especially for our premature babies. I'll give you a little history there. So we probably about 10 years ago had a kind of a journal called that was a debate, pro and con. And I worked with a couple of fellows and somebody else worked with a different couple of fellows
Jon Swanson (19:35.556)
kind of came together with all the evidence and we decided not to, much to my dismay. So even though I'm a medical director, I don't make those, you know, those vast changes across the unit, which I think is important. And so I think the biggest concerns were one, not having a kind of, I'm not going to say regulated, but a
pharmaceutical grade type of probiotic, where you knew the safety. And this was just a couple of years after an infant died of a fungus infection. I think, I don't know how long ago that was, but I'm sure you guys are aware of that. So pharmaceutical grade, and then a lot of the evidence, every paper is a little bit different, which probiotics are we using? And I think we all agreed, it looked like, and I would still say this,
Daphna Yasova Barbeau, MD (she/her) (20:02.918)
standardized. Yeah.
Jon Swanson (20:29.94)
use would probably have at least two strains of probiotics, one of which being Bifidobacteria, some type of that. And so then as Vivo came out and Abbott brought Tri-blend out, I was getting really excited. All right, here we are. They're not FDA regulated. They're not FDA approved, but these are companies that I feel like I could trust with providing a
a safe product. And I think that was one of the big components that people were afraid of. I think if we're Abbott specifically, and I'm not a speaker, I don't have any conflict of interest with either of those two, we're providing their formula to our patients. We're recommending that for healthy term babies. I'm going to trust that they're...
And maybe I shouldn't, but I'm going to trust that they're providing a product that is safe and generally acceptable for people. And so when these products came out, I was really excited. I was like, all right, finally something that I can get my team around and really latch onto, because I think it was important. I think everyone has now realized that the change in microbiome is probably what precipitates NEC. And if we can decrease that even more.
I think that's going to be a godsend. Medical NEC and surgical NEC are not without long-term consequences, even if a baby survives. There's tons of evidence out there that, especially surgical NEC, that is probably as bad as having a grade 4 intracranial hemorrhage when it comes to neurodevelopment.
And so I think any ability, any way of decreasing these long-term complications, I think, and we have a discussion with families, I think is really important to move forward for the, what am I trying to say, is really important to move our, I have no idea what I'm trying to say.
Ben Courchia MD (22:41.654)
Our team? No, no worries, no worries, no worries. But you're, you're talking about trying to move the needle forward with a set of partners, I guess, which include both, both your families, your colleagues, and the industry, which has to provide these, uh, these quality controlled products that you say, okay, I can, I can actually use this and not some, some guy dropping off with a, with the truck saying, I got some probiotics, if you...
Jon Swanson (22:52.589)
Yes. Okay.
Jon Swanson (22:59.661)
Absolutely.
Jon Swanson (23:03.471)
Yes.
Daphna Yasova Barbeau, MD (she/her) (23:10.196)
Mm-hmm.
Ben Courchia MD (23:10.326)
if you're interested.
Jon Swanson (23:10.424)
Absolutely, absolutely. The way I looked at it, you know, I can get probiotics at, you know, your local drug store, GNC. I have no idea what's in that. I have a little more faith in, you know, Evivo, this is our, Infinite Health. This is what they did, right? This is what they were going to make or break with that. Abbott, I have a little more trust in them. Maybe I shouldn't, you know, maybe I'm a little too cavalier with that. But I think having that ability to have that discussion with families,
Daphna Yasova Barbeau, MD (she/her) (23:17.402)
Mm-hmm.
Jon Swanson (23:39.128)
You know, all right, this is the evidence. This is what we have. These are not FDA regulated. What do you think? I think we need to provide some of that information to families.
Ben Courchia MD (23:41.122)
And this is why we're...
Ben Courchia MD (23:50.306)
I think as we were trying to roll out probiotics, we're no longer using probiotics in our unit, unfortunately, due to this FDA sort of fiasco. But I think one of the administrators was like, why is the antibiotic, the probiotic you're recommending more expensive? Can't you just use some cultural from like CVS? And we're like, well, it's not really the same thing.
Daphna Yasova Barbeau, MD (she/her) (24:05.93)
Hmm.
Daphna Yasova Barbeau, MD (she/her) (24:09.476)
Yeah.
Jon Swanson (24:09.98)
Yeah, we actually had, we had culturel in our, in our formula and I was like, I feel like that was useless. That's not going to change anything. So we actually got tri blend in our unit prior to this as well. And thankfully I've never had a baby in the NICU. But if I did, I think probiotics is one of those things that I would be asking for, knowing the impact and all the evidence that's out there. If I had a baby that was, you know.
Daphna Yasova Barbeau, MD (she/her) (24:12.738)
Mm-hmm.
Ben Courchia MD (24:12.823)
in our pediatrics, right?
Ben Courchia MD (24:18.371)
No, no, no.
Yeah.
Ben Courchia MD (24:30.608)
Mm-hmm.
Jon Swanson (24:37.8)
small for gestational age, very low birth weight, infant in the NICU, I would be advocating for that.
Ben Courchia MD (24:43.77)
Yeah.
Daphna Yasova Barbeau, MD (she/her) (24:44.014)
Well, I think you guys bring up an interesting point also when we talk about how readily available it is. And obviously the extremely low birth weight infant is a different population, but the lay public has really bought into probiotics as a health supplement in their families. And that includes to their term infants who go home from the nursery. And I mean, the amount of infant probiotic that is purchased off the shelf.
I think it's interesting because we have not had the opportunity to study those babies, but it's a big number of babies. So, you know, I just wonder if we did have the opportunity to study those babies, what we would find and if that would help us in any way.
Jon Swanson (25:28.868)
And your listeners can't see me shaking my head, but absolutely. I totally agree with you. And I think that's what we should be advocating for as a field. The FDA said, we need more clinical trials. And who's going to pay for that? And I would think with all the evidence out there, and Ravi Patel has said this multiple times. I think it's like 80,000 infants or something like that out there.
Ben Courchia MD (25:30.734)
Hahaha
Jon Swanson (25:58.416)
He was just on with you guys when this broke. The amount of money needed to spend to change what we already know, I think there are better uses of that money. So I think if we could, as a field, knowing that these are not randomized controlled trials, but really look at what people have demonstrated. There's not a lot out there with Evivo.
Ben Courchia MD (26:05.17)
Thank you.
Jon Swanson (26:24.424)
But Brian Scodellini at Oregon provided, you know, he had a before and after trial, which showed benefit there. I'm not aware of anything with TriBlend yet, but I'm sure there's tons of centers that have a before and after. It's been out for a while. And is the FDA going to take that data and show that one, it's generally safe? Certainly.
cases of probiotic sepsis have occurred. We've known that since, you know, before we started using probiotics really, that it was a possibility. And it occasionally happens. But the number of kids that you have saved from NEC and NEC mortality from utilizing probiotics, I think we can't just discount that because it's not a randomized controlled trial.
Ben Courchia MD (27:13.89)
I think you're bringing up so many good points right now, and we'll have maybe one or two more episodes with Dr. Jonathan Blau from New York, where we'll talk about these precisely, both a bit of review of the evidence as well, but some of these stories of pre and post implementation and some of the effects that were reported both in the literature and also from his firsthand experience as well. I am wondering now that as we're discussing the clear demonstrated benefits
of probiotics and we're talking about some of the challenges that we are facing. You mentioned earlier the importance of communicating with families and I am wondering if you perceive that maybe families will have a role to play in whether or not or how probiotics are being reintroduced in the NICU in the future because these are families that are for the most part very well read. They inform themselves.
quite well about their babies and the pathologies that they're exposed to. And they're, they're in a predicament where, as you said earlier, like the need for antibiotics in the NICU is not frivolous, many infants, it's a, it's a life or death situation. We don't just dispense antibiotics, uh, willy nilly. And then when you put that in, in the balance, you say, well, I do need this other option and I am wondering if, if you think this, that families will, will have a role to play and, and if, if they do, then
how big of a role do you think they'll have to play in swinging the pendulum back in the other direction?
Jon Swanson (28:48.492)
I think they do have a role to play and I think they should. I think it all goes back to, I think, I'm not sure we really know what constitute or what made the FDA make this sudden change. You know, we do know that a child died after having developed sepsis. We don't know if the child died because of sepsis, but the child died after having sepsis with the same organism that is in Evivo. Was that the only one? Was that the?
the instigating case for the FDA to review all probiotics in the NICU? I don't know, or was there something else going on? Not trying to be a conspiracy theorist at all, but I think, you know, knowing the reasons why the FDA came down pretty harshly on Infineon and Abbott is probably going to help us better understand how to make that change.
I think the parents can certainly play a role because I think if you provide the evidence unbiasedly to a family, I think 99 out of 100 probably would choose probiotics, you know, at least for a subset of patients in the NICU. Maybe it's not the ELBWs, maybe it's those very low, you know, between 1000 and 1500 at the very least, but those kids develop NEC as well.
and they get a lot of antibiotics. And so, or maybe it's the kids that are on antibiotics long-term or they got five or seven days. But I think reclaiming that microbiome with probiotics can be helpful. And I think providing families that information, I think majority would choose, all right, let's try this. It's generally safe. There is a risk. Everything that we use in the NICU has some risk.
I would say formula has some risks. And that absolutely, we've all seen cases of that as well, right? But we're not going to not insert an NG tube, right? And antibiotics have a risk. I've seen, even TPN, I've seen bad IV infiltrates from TPN or pick line issues. And so I think we all do what we think is best for the family or for the patient.
Ben Courchia MD (30:42.47)
And inserting the ng-tube is a risky procedure. Ha ha ha. Yeah.
Daphna Yasova Barbeau, MD (she/her) (30:47.357)
Mm-hmm.
Ben Courchia MD (30:50.555)
Thank you.
Ben Courchia MD (30:54.724)
Yeah.
Jon Swanson (31:09.612)
and that includes the family. And I think having a family voice talk or speaking to the FDA, I think is going to play a role as well. I don't know anybody in the FDA, I don't know who made the decisions, but we have families here who have experienced the NICU, have experienced NIC, and I think they can speak to the value of this therapy moving forward, probably even better than you and I could.
Ben Courchia MD (31:19.247)
for sure.
Ben Courchia MD (31:37.794)
Yeah. And I think it's going to be a compounded effect, especially since usually in the U S we have the benefit of being on the cutting edge of therapeutics, right? We have access to a lot of things that the countries don't have access to. But for the first time, we're going to find ourselves in the backseat where we're going to be like, this is a therapy. We know it's proven and our colleagues in Europe, in Australia, in Japan, all these guys are using it. We're not. And I think that's going to probably create a divide that's going to get wider and wider.
Daphna Yasova Barbeau, MD (she/her) (32:02.082)
Mm-hmm.
Jon Swanson (32:07.418)
Mm-hmm.
Ben Courchia MD (32:07.646)
as time goes on and maybe we'll blush a little bit more at these conventions where we're going to find out that our NEC rates are maybe a little bit higher than our international colleagues.
Daphna Yasova Barbeau, MD (she/her) (32:13.442)
Mm-hmm.
Jon Swanson (32:16.672)
Yep. And I think, you know, we have a couple of very large organizations that have multiple NICUs. Hopefully many of them were using probiotics. And, you know, we may see within a year, maybe a year and a half, that there are now changes in the NEC rates in these centers. And I think even though that's not a randomized control trial, we're going back to that question.
I think the FDA needs to take notice of that. And hopefully we'll be able to utilize some of that data to move forward and kind of open up that market again.
Daphna Yasova Barbeau, MD (she/her) (32:47.726)
Mm-hmm.
Daphna Yasova Barbeau, MD (she/her) (32:54.782)
Yeah, I wonder how you feel this will impact, obviously, research and probiotics and how much of a setback that will be for this trajectory, at least here in the States. And then, you know, what responsibility do units have to kind of get their individual data pre, post, and back to, you know, pre probiotics again for us all to look at together.
Jon Swanson (33:23.456)
Yeah, well, I think certainly clinical trials are going to be, that might be the only way to use probiotics, you know, but I think IRBs are going to require an IND and all of that. And so I think anybody trying to do a clinical trial with probiotics is going to need money and time and it's just going to delay things. You know, I think it kind of goes back to, you know,
even if you go back to the AAP statement on the use of probiotics, which I think was our kind of first step back, might be personally, not an author, and I haven't spoken to them about that. But, you know, I think it would have, I think it's important for when we don't have something that is regulated or we don't have universal consensus on that we as a group really learn from each other. All right.
We, you know, there's a lot of different probiotics out there, but maybe over time, if everyone shared their data and, you know, whether it's through papers or conferences or what have you, I think we would have a better understanding. You know, you can, it doesn't have to be randomized control draw, but, you know, using quality improvement methodology, you know, you can demonstrate that there was a shift change in your NEC rates, um, through process control charts. And, and even that.
is should be generally accepted as evidence that these were beneficial or not beneficial. And each unit might be different because of different care practices. One unit may use more antibiotics than another and probiotics may be more beneficial or less beneficial because of that as well.
Daphna Yasova Barbeau, MD (she/her) (35:08.234)
Yeah, as we're nearing the end of our time together, and we're trying to make the case about kind of the burden of NEC, obviously we've spoken to the tragic mortality that we see in NEC, but you've written a lot about some of the additional morbidity, and maybe you can tell us a little bit about what we find in this kind of systemic inflammation and the associated kind of other end organ damage that we see.
Jon Swanson (35:35.052)
Yeah, well, I think the key to that is the brain, obviously. Anytime you have inflammation, the inflammatory mediators, where are they going to go? They're going to go all over the body, but I think the brain is probably the most susceptible. And what really latched me onto this was a paper, and I think I wrote an editorial about it 10 years or so ago, that looked at infants with intracranial hemorrhage, grade four intracranial hemorrhage.
And they looked at a number of factors to figure out, what has the most impact on neurodevelopment? So these were all babies that already had grade four. What had the most impact on worst neurodevelopmental impact? And the author is escaping me, but they found that kids with surgical NEC had as much of a risk of severe neurodevelopmental impairment as those that had...
a shunt placed. And so I think we all know, all right, you have grade four and you have a shunt. Oh, wow. The likelihood of normal neurodevelopmental trajectory is probably has a, there's a high rate that aren't going to achieve that. But in just reviewing this and understanding that NEC, even so kids with grade four, but didn't need a shunt, NEC has as an important part to play in neurodevelopment.
as those that had hydrocephalus or needing to have their CSF shunted. I think that just played a significant role in my understanding of the importance of not allowing these kids to achieve NEC. And if so, at least trying to decrease the severity of NEC. Medical NEC, I think there's a lot of evidence out there that.
I don't think anybody has really shown a significant difference compared to those without NEC. There is a slightly higher incidence of some neurodevelopmental impairment, but when you look at the statistics, it probably doesn't pan out. And so I think if we can at least decrease the severity of NEC, I think that's going to be a key driver of improving outcomes long term.
Daphna Yasova Barbeau, MD (she/her) (37:54.214)
My last question for you, and we've spoken a little bit about families, but you have won the Bedside Manor Award, best Bedside Manor Award, many times. What's your key to connecting with families?
Jon Swanson (38:07.648)
Um, you know, I think really, I think one, you know, I think we all have a different personality and I think you have to utilize the strengths of whatever personality, um, that you have, how you, how you talk and things like that. I think the thing that I have found to best for me, um, is just to make myself slow down when I am with families. And so when I come.
to meet a family on a bedside, I try and sit down. Because if I'm standing, I try to, all right, oh wait, I got something else to do or things like that. And so sitting down and facing them, you know, face to face, I guess that is facing them, but getting face to face with them and allowing them to kind of just, you know, verbalize their thoughts and their feelings is really key. And so I think for me, it's just really slowing down and allowing the family to open up. And that's...
but I try and do. And I can't say I do it 100% of the time. I think we're all busy clinicians, but certainly when... Well, I don't know about that, but I think that's the key. And I think we all talk differently. I think just finding a commonality between families. So I'm a big baseball fan. And so when I see a dad with a Yankees hat,
Ben Courchia MD (39:07.994)
It sounds like your success rate is pretty high to be honest when you're winning the award.
Daphna Yasova Barbeau, MD (she/her) (39:10.251)
Hehehehe
Jon Swanson (39:29.156)
viewers can't see it, but I got a Mets thing on my back wall. I give them a little ribbing. We have a lot of, we're obviously at UVA, we have a lot of Virginia Tech Hokies fans. And so I can play that role as well. And I think some of my colleagues could care less about sports. And so they're not going to dive into that. But I think just finding a commonality that you have with families.
no matter their background is a key component as well.
Ben Courchia MD (40:00.046)
I like that. I think this is a great place for us to end. John, thank you so much for making the time. This was a super enlightening conversation. We thank you for your time. This was great.
Jon Swanson (40:07.056)
Thank you so much for having me. So you guys are doing a great job. I think everyone in the field of neonatotology Thanks you for all that you've done Especially especially going to all these conferences and providing some real-time feedback that we only had on X or Twitter Whatever you want to call it. And now we have a little bit more Understanding. So thank you Yep
Daphna Yasova Barbeau, MD (she/her) (40:15.874)
Mmm.
Ben Courchia MD (40:28.214)
Appreciate your time. Thank you.
Daphna Yasova Barbeau, MD (she/her) (40:29.218)
Well, thank you. Bye.