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#190 - 🦠 Probiotics Mini-Series - Strains, practical implications and the FDA (ft Dr. Jonathan Blau)





Hello Friends 👋

In this episode, Dr. Jonathan Blau discusses the FDA warning on probiotics and its implications for the future of probiotic use in the NICU. He expresses mixed feelings about the FDA's involvement and highlights the need for regulation while also expressing concerns about the way the warning was issued. The debate between single-strain and multi-strain probiotics is also discussed, with Dr. Blau emphasizing the importance of using the triple strain recommended by ESPAGAN and AAP. He shares his experiences with rolling out probiotics in his NICU, including the decision-making process and the involvement of different disciplines. The administration and preparation of probiotics, as well as the consent and assent process, are also explored. Dr. Blau concludes by discussing the outcomes of probiotic use in his NICU and the ethical considerations surrounding the use of probiotics.


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Short Bio: Dr. Jonathan Blau is Director of Neonatology at Staten Island University Hospital in the Northwell Health System and Associate Professor of Pediatrics at the Donald and Barbara Zucker School of Medicine at Hofstra/Northwell. His academic interests include the neonatal microbiome, antimicrobial stewardship, NEC and preterm nutrition after NICU discharge. After receiving his MD from the Stony Brook School of Medicine, he completed a pediatrics residency at the NYU School of Medicine and neonatology fellowship at New York Medical College. He recently completed a five-year term as President of the New York Perinatal Society and has been voted "Northwell Teacher of the Year" for the Northwell Health System in New York. Dr. Blau is an active member of the Society for Pediatric Research.


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Effects of prophylactic probiotics supplementation on infants born very preterm or very low birth weight. Chiruvolu A, Hendrikson H, Hanson R, Reedy A, Reis J, Desai S, Suterwala M.J Perinatol. 2023 May;43(5):635-641. doi: 10.1038/s41372-023-01657-w. Epub 2023 Mar 30.PMID: 36997802


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The transcript of today's episode can be found below 👇


Ben Courchia MD (00:01.794)

Hello everybody, welcome, oh sorry. Hello everybody, welcome back to the Incubator Podcast. We are back for episode two of our series on probiotics and we are back with Dr. Jonathan Blau, who was here with us yesterday. Jonathan, thank you for coming back.

 

Jonathan Blau (00:18.559)

Thank you, Ben. Thank you, Daphna. Happy to be here.

 

Ben Courchia MD (00:21.49)

Yeah, Daphne, how are you?

 

Daphna Yasova Barbeau, MD (she/her) (00:23.135)

I'm doing well, I'm doing well, excited to learn more for sure. We learned so much in the first go. So, my first question really we've,

 

Ben Courchia MD (00:31.71)

Yeah.

 

Daphna Yasova Barbeau, MD (she/her) (00:35.355)

So we've been dancing around the quote unquote FDA warning, but they, just to be thorough, they issued this Dear Healthcare Provider letter on September 29th of this year after, like you mentioned, the death of Anil B.W. So I'm curious, it seems like for a very long time, we were hopeful that the FDA would get involved with the probiotics.

 

in an effort to get a more standardized product for units. I think we certainly didn't expect that they'd get involved in this way. So tell us what you think the FDA warning means for probiotics and what you think the future probiotics looks like in the near future.

 

Jonathan Blau (01:25.856)

Thank you, Daphna. So

 

Jonathan Blau (01:30.999)

mixed feelings about this. I am glad that the FDA has begun to become involved in the probiotics discussion. I have concerns about the way it was done and my concern is that we're going to see increases in the incidence of neck as a result. You know, as we are aware

 

counterparts of the FDA do regulate probiotics in Canada, in Europe, in Japan, in Israel, other countries with much higher uses of probiotics than the United States. So I think regulation is good. I think it's going to help us roll, long-term I'm talking about, it's going to help us roll out probiotics to more centers in the United States. And potentially...

 

prevent more cases of neck that we have seen prevented in the units that are part of these studies, for example, where we've seen the 30 to 40% risk reduction in neck. My concerns about the September letter to the neonatology community is that really it

 

probiotics were painted with the same brush. And that is something that I might have handled differently if I was part of that decision making. There wasn't really a discussion of really any of the evidence behind probiotics either. So some folks have called it a cease and desist letter. I don't know if it was that.

 

Ben Courchia MD (03:24.847)

It felt a bit like that though.

 

Daphna Yasova Barbeau, MD (she/her) (03:27.687)

Thanks for watching!

 

Jonathan Blau (03:27.907)

I think I see where that's coming from. I think it was slam the brakes. There has to be a lot of caution. Although cease and desist, it may have been similar to that as well. But our rollout in our own unit of probiotics, we spent a lot of time. You know, we spent a year researching which probiotic.

 

preparation we were going to use. And we really found the best advice from ESPAGAN, the European Society of Pediatric Hepatology and Nutrition that I had discussed yesterday. They studied multiple preparations and they recommended the triple strain of B. infantis, B. lactis, and strep thermophilus, very prevalent in breast milk, that triple strain.

 

they recommended against single strain use. And of course, the AAP statement, which came out the following year in 2021, recommended also against the single strain use. And they actually cited the ESPGAN recommendations from the year before as a reasonable recommendation, the triple strain. So none of that was mentioned in the FDA letter. None of that...

 

You know, what was talked about, the history of all of the evolution of this, you know, the some companies who are, who are, you know, marketing single strains that they've been calling me for the past few years because we used the triple strain for almost three years and stopped at the end of October of 2023 for because of medical, legal and regulatory concerns, unfortunately. And my answer is always the same.

 

We're not going to use single strain. It is not recommended. It's recommended against actually. And why does it matter? It matters because we're really looking at a very sensitive balance of commensal and unhealthy bacteria in the microbiome in the neonatal GI tract. And it's really important in terms of what product you use. And JAMA pediatrics, which we discussed in the last episode.

 

Jonathan Blau (05:45.231)

that they found in September with a meta-analysis over 25,000 patients in that paper that the triple strain had the best morbidity and mortality outcomes. So I kind of wish that there was some of that discussion in the FDA letter rather than the, you know, slam the brakes and really you all need to pause right now.

 

Ben Courchia MD (06:08.478)

I think it's, I mean, I want to challenge you a little bit on this because I think the idea that single strain versus multi-strain are different is absolutely true. But I would say, would you really say that the single strain is something that should be advised against? I mean, the recent meta-analysis from JAMAPEDES and that was recently published, does show that multi-strain probiotics has a relative risk of like 0.38 compared to a 0.61 for...

 

single strain, which clearly is a dramatic difference. But do you think there's still some benefit for single strain or would you in your experience and your review of the literature say that maybe there are other concerns with single strain probiotics?

 

Jonathan Blau (06:54.929)

I think there is some potential benefit, but...

 

In addition to the FDA, we had ESP again advising against it in 2020. And then we had the AP sort of doubling down on that in 2021. So, listen, I want us to begin to use probiotics again, safely, of course, as soon as we can. I think it's now going to be that much harder for that case to be made that there should be a trial of a single strain.

 

We have those two professional societies advising against and we have the very tragic mortality that we learned about in September of a baby receiving a single strain. So I agree with you, Ben. I don't think that this is, you know, that there's no good whatsoever in single strain. I just think the deck is really stacked against single strain right now and I wouldn't want us to waste, you know.

 

precious time where patients, where no one is getting probiotics, which is almost what's happening right now while we're pursuing a single strain kind of hypothesis as a community rather than the triple strain.

 

Ben Courchia MD (08:13.578)

So we wanted to maybe spend a little time this episode to talk a little bit about, not a little bit actually, a lot of talk significantly about your experiences rolling out probiotics in your NICU. Obviously, as you mentioned, this is something that came to a halt in October with this whole FDA warning. But I do think that

 

This moratorium in which we are in is probably temporary. And I think we will be soon enough in a position where we're going to reintroduce the use of probiotics in the NICU. And so can you tell us a little bit about your team's efforts to introduce probiotics and maybe begin from the beginning? How did you convince your team that this was something that needed to be done? Because I feel like when we've spoken to a lot of neonatologists, the first step is saying there's a lot of

 

dissonance in my team. Some people saying, yes, we should use them. Some people saying, no, we should not use them. So how did you guys come up to a fairly to a fair consensus to say, okay, we're going to do this together.

 

Jonathan Blau (09:18.401)

That's an excellent question, Ben. So how did we get there and kind of what were the stumbling blocks internally within our own unit towards making probiotic use from an idea to a reality for our patients? So how did we get there? For us, in retrospect, I think it seems relatively straightforward looking back.

 

You know, we had donor milk, of course, which we launched in 2016. And we used it initially for BLBWs. Now we're using it, you know, with more liberal inclusion criteria than that. And I hope to liberalize that even more going forward. So we were doing that. We were really doing what we thought was the best way to do it.

 

thought was a good job about antibiotic stewardship. And of course, I think our field has been some of the guiltiest offenders, if I might use that word, all of us, with kind of overprescribing antibiotics. And our patients are immune suppressed. And if you miss a case of sepsis, it is a disaster. So I'm not trivializing the need to worry about sepsis, but I think we all know. And the evidence and the literature really shows we have been treating too many...

 

patients with antibiotics and we have, we're all doing much better. We all continue to need to, we need to continue to improve every, all of our units, but we're doing much better. So we really were doing well, we thought from a neck prevention, you know, point of view. And then we had a cluster of three. Two of them had mortality. And one.

 

one survived. Two of the three were surgical. And this was really very humbling. Medicine is very humbling. I think that's a good thing. I think it should be humbling. It keeps us on our toes. It makes me, I'm sure it makes everyone better neonatologists. But this really was...

 

Jonathan Blau (11:30.827)

really reckoning for us. You know, just because we're doing all the things we think we should be doing or that we're reading we should be doing does not mean that that's actually the case. And you know, this is back to how important evidence-based medicine is. We went back to literature. What else can we do? Because what we're doing, it's not enough. And we read about probiotics really in detail. We read certainly everything that we could get our hands on.

 

And we really took our time. It was about a year and a half from that neck cluster of three to our launch of probiotics. And we took about six months to go through everything and really talk to all of the different disciplines. This is kind of the second part of the question. Different disciplines within our unit about this. We spoke to nursing, of course. We spoke to our

 

advanced care providers or NPs and PAs. Of course, all of our neonatologists, we spoke to our pharmacy folks as well. We spoke to our nutrition dietitians and you know, I think leadership, medical leadership is always, you know, kind of optimized if we can take all of the smart folks that we work with in different disciplines and get everybody's

 

you know, opinions and hear their concerns because we all come to the table to help, but from a kind of a different vantage point. I think that's a strength. So we spoke to a lot of folks. We had a lot of different meetings. And you know, I would say one of the most important things was speaking with our nursing leadership, as well as really partners on this.

 

but we were able to answer a lot of folks' concerns and folks' questions and issues with pharmacy and our institution, our pharmacy folks, they were part of the decision to consider this in our center, a dietary additive through the nutrition diet, nutrition pathway as opposed to a drug that is ordered and comes from pharmacy. And I personally really stayed out of that.

 

Jonathan Blau (13:51.063)

We wanted to hear what the other folks wanted to do. And I think consensus and really listening to everybody and making feel everyone heard was very important. We ended up with our research in the area. We ended up choosing that triple stream that I talked about. That was actually one of the.

 

I think easier decisions of the whole process because ESPGHAN had really laid it out so nicely in my opinion for this. So that's kind of how we got there and really just multiple discussions with all the different stakeholders, so to speak, I think made this the launch of success.

 

Ben Courchia MD (14:39.359)

My question then following up is that everybody's asking this, if we have to use probiotics, who is responsible? Should we give this under the umbrella of pharmacy? Is this something that's going to go in the milk room? That's just a nutrition product. How did you guys navigate this dilemma?

 

Jonathan Blau (14:57.111)

So that's a very important question. And I think we've seen that there are units who feel very strongly that should go through the pharmacy pathway. And there are some units that feel very strongly that should be something that the milk techs are taking care of in the milk room. So again, I think talking to everyone involves having everyone in a room and discussing this is really kind of the first step.

 

Jonathan Blau (15:29.032)

in our unit, our new Women and Infants Center, we're very excited, is opening in four months. We will have a milk room there. We don't have a milk room now. So that made our discussion, I think, a little bit simpler than it was for other units. But I...

 

called the VP of Pharmacy and we discussed probiotics, you know, for the third time. And I said, what are your thoughts on this going through pharmacy or this going, being a dietary additive that nursing mixes, just like they mix HMF, which next year will be mixed by Milktex.

 

And we talked for a while and he told me that he didn't feel strongly about it. And, you know, he discussed with his colleagues and they said that they were fine having it as a dietary additive and for pharmacy to stay out of it. That was the, that was the phrase he used. So listen, that worked. Our, our nursing leadership was more than happy to take this on. And, um, you know, uh, that's, that's how this all worked out, but I think every institution is different. Culture is different.

 

Pharmacy culture, milk tech culture, nursing, it's all different. So, you know, what worked for us certainly may not work in other units. So you really kind of have to do your homework and talk to your colleagues.

 

Ben Courchia MD (16:52.098)

Fair enough, but you guys were successful. So it's kind of interesting to get your roadmap. Since we're talking about this, so it went under dietary supplements, which means that nurses would basically prepare the probiotic themselves. How did you, that I think involves, can put a little wrinkle in how nurses prepare their usual nutritional products. I think now you're introducing a live bacteria. Did you guys have to?

 

Jonathan Blau (17:09.667)

correct.

 

Ben Courchia MD (17:21.722)

separate where the probiotics were mixed from where the milk was mixed? Or did you guys do all this in one room? And how easy was it to get your nurses to take this on? Because I think the idea of preparing nutritional supplements is not beyond the realm of the nurses. But I'm really curious about the fact that now you're saying, hey, you're preparing something that is formula that should be relatively clean, but now you're going to manipulate the live bacteria around there.

 

aerosolization of bacteria is something people have talked about. How do you guys deal with all these potential pitfalls?

 

Jonathan Blau (17:56.419)

So we reviewed with our nursing leadership, our nursing educational units, and bedside nurses that there have been no cases reported of contamination to babies resulting in bad outcomes. And I'm talking about that probiotic associated sepsis that we talked about in the last episode. There have been no cases whatsoever. We

 

have always followed the recommendations from the infection control folks. I'm blanking on the name of the society for mixing of dietary additives, but they recommend for the NICU to mix these products in a nonpatient care area. And we certainly have that and our nurses mix it there. We really didn't do anything different than that because there are not there aren't any

 

other recommendations for mixing probiotics and many, many centers do this, mix the probiotics in this pathway, you know, the non-pharmacy pathway. It's interesting because, you know, speaking to different centers, some milk techs, milk banks, they say it's dietary, we want it, we want to own it, and this and this, and some folks in the milk room say...

 

I don't want any bacteria in my milk room. I don't want to touch it. I don't care if I have gloves on. I want nothing to do with it. So there's really different opinions on this. Could it become aerosolized? I guess it could, but we're mixing this into a small cup. We just don't have any reports of this in the literature. And I guess...

 

There are so many things we might worry about, not just for this intervention, but others, but I was really trying to stick to what we need to be concerned about, what's happened in other places, and you know, versus things that we can theorize about, but we haven't seen any clinical concerns in the literature.

 

Ben Courchia MD (20:02.484)

I know Daphna had some questions about how you guys were able to navigate consent. So I'm going to let Daphna take this on.

 

Daphna Yasova Barbeau, MD (she/her) (20:09.551)

Yeah, well, I guess that's really the question. I think even when you were rolling out probiotics, there was already a lot of debate and discussion in the community. So what did that consent, but I think assent process look like in your unit?

 

Jonathan Blau (20:29.555)

So, Dr. that's an excellent question and something we've talked about quite a bit and I think as a community we are going to be discussing this, you know, hopefully with, in more detail, hopefully with the path back to probiotics after this, you know, so-called moratorium or whoever we want to call it, hopefully ends. But from the beginning, our position has that.

 

written sign consent is not necessary. We obtained written consent for actually very few things in the NICU and we did not see the need to add this intervention to that. So what we do is we were obtaining verbal assent. So around 48 to 72 hours of life, hopefully the RDS is improving at that point.

 

And this is the time where we really kind of move on to the next phase of discussion with the families, you know, the ventilator, that type of stuff is hopefully improving, the sepsis, all of that. But we're now going to talk about focus on nutrition and how nutrition is such an important part of what we do. And we're going to talk about optimizing, you know, moving past trophic feeds and optimizing enteral nutrition.

 

and the use of fortifiers, you know, with fortification, you know, we fortify at 60 mLs per kg per day. So, you know, for us that discussion happens relatively earlier, I think. But in that same discussion, we talk about probiotics, how probiotics is something that's used for neck prevention. We do discuss neck in that conversation. And of course, these patients, you know,

 

too young, so to speak, to have neck too early in their lives to have neck. We're going to see it a few weeks later. But we discussed what neck is and why the feeding advancement needs to be on the slower side. We can't just go to full volume and get you off TPN in 24 hours. And we have this intervention probiotics. We treated nearly 100 BLBWs with probiotics in the two years and...

 

Jonathan Blau (22:49.335)

nine months that we were using the triple strain and not one parent declined probiotics. Actually just anecdotally off the top of my head and speaking to our other faculty, a lot of families were very happy to hear about probiotics. We often got a big smile. I take probiotics or my two-year-old with stomach.

 

you know, constipation, the pediatrician put him on probiotics and my mother takes probiotics and I buy, I eat kefir every day and we have a, we're in New York City, we have a very economically and racially diverse patient population so it's, you know, it's not, you know, we're seeing a lot of different folks from different backgrounds in our unit. But really the response to probiotics was overwhelmingly a positive one.

 

And that's where we left it, verbal assets. And I always think, because this question comes up a lot, and it's a very good question. It's going to come up a lot probably in the next year as we negotiate our path backwards, hopefully, which I believe will happen. But when your kid is crashing, when we're on call at 2 o'clock in the morning, and I have to put in a chest tube,

 

and I have to intubate and I take blood and urine culture and I start vanco and amicase and I'm not, I'm calling you when I'm done at 2 a.m. to explain to you what we've had to do and what happened but I'm not getting your written consent, you know, and I don't see why probiotics need to be added to that. And some folks have said, well the FDA, it's not approved, but to me,

 

Daphna Yasova Barbeau, MD (she/her) (24:18.352)

Hmm?

 

Jonathan Blau (24:32.567)

there are most of the products, I think we're all aware of this, most of the interventions we use are a large percentage of them are not FDA approved for that indication. Furosemide, I don't think we should be using too much furosemide, but we do use it. And that's not FDA approved for our patients. A lot of the antibiotics we use are not FDA approved for our patients. Dexamethasone, DART therapy, all these types of things. So,

 

Daphna Yasova Barbeau, MD (she/her) (24:37.404)

Mm-hmm.

 

Ben Courchia MD (24:41.59)

Mm-hmm.

 

Jonathan Blau (25:01.239)

For us, that was not a kind of an argument why we should be obtaining written consent and kind of singling out this therapy to have this kind of regulation.

 

Daphna Yasova Barbeau, MD (she/her) (25:13.955)

Yeah, I love that you brought that up.

 

Ben Courchia MD (25:15.761)

Jonathan, I wanted... Oh, sorry.

 

Daphna Yasova Barbeau, MD (she/her) (25:18.871)

I love that you brought that up. Actually, when we spoke to Ravi Patel about this issue, that's was his perspective as well. And I wonder, my follow-up question to that is, do you think the discussion around probiotics will change how we talk about some of the other medications we use in the NICU? Like you said, we use them because the benefits outweigh the risk, but so many of our medications still carry risk.

 

Jonathan Blau (25:55.185)

I would not be a proponent of adding written consent forms to an ever increasing list of therapies that we provide. I think we need to do things properly.

 

When we talk to, well, there's emergent and non-emergent therapies. You know, emergent we talked about like that 2 a.m. and, you know, your kid crashes and all of that. But, you know, non-emergent things, you know, everything has side effects. Iron drops have side effects, you know, GI distress, all of these type of things. I think we need to discuss things with our families ethically, like we all aim to do. And we need to mention side effects.

 

You know, how far are we going to take this? Are we going to, when you and I go to the internist or our PCP for annual checkup, is every, you know, medication that adults, do we need to sign a written consent form for all of this? I think it's unreasonable. I think it adds to confusion among patients. And I think it adds really an unnecessary burden to everyone in the NICU providing care.

 

And if there was an ethical reason to do it, I'd be more open to it. But I don't believe that there is. I just don't think, you know, ethically, we're obligated to obtain written consent for an increasing list of therapies. We discuss side effects. We should discuss side effects. You know, when we do a three-day course of furosemide in my unit, we talk to them about the side effects because why are we only giving it for three days? You know, that's just an example. I don't need.

 

I don't see what we're gaining ethically, medically, or trust with the parents by getting written consent that you're aware of what it does with the calcium and the bones and the nutritional status and all of that. So I would hope that that's not the direction we're moving towards.

 

Ben Courchia MD (27:50.222)

Jonathan, as we're getting close to the end of this episode, I'm just curious if you could share with us, I know you're working on the manuscript of your experiences at Staten Island Hospital. What have you been your experiences with the rollout of probiotics in your NICU and what kind of outcomes have you observed?

 

Jonathan Blau (28:08.215)

So our experience has been very positive. We have seen a non-statistically significant trend towards reduction in neck and late onset sepsis. From neck we've gone about 5% to about 1.5%. I wish we had that magic p-value, less than 0.5. We have about 80 patients in each group and it's just certainly not powered enough.

 

But in terms of clinical benefit, we were very pleased. We really were very pleased with this. And this is what we're looking for. And we talked about in the last episode, the proper design of a study, we would love to have tens of thousands of patients where we can possibly achieve that P value. But until we get there, this for us was just mirroring what has been seen.

 

in the prior literature on this topic.

 

Ben Courchia MD (29:11.97)

Do you think that this has to do, I mean, do you think that the lack of statistical significance purely has to do with the fact that you are not having at this time enough babies to have to reach statistical significance or do you think it's due to anything else?

 

Jonathan Blau (29:30.447)

I think it's primarily for that reason and that's why the meta-analyses largely have shown statistically significant reductions in NEC. And there are the inherent problems with meta-analyses and Cochran reviews. You're not comparing the same kind of apple in the 50 different studies that you're looking at and I respect and appreciate that. But overall, these meta-analyses are showing...

 

quite statistically significant trends in neck reduction. So I really just think it's a numbers game. And we may one day be able to accomplish that as a field, but to my knowledge, there's nothing kind of on the planning board right now going on.

 

Ben Courchia MD (30:18.446)

Okay. In terms of the ethics, I wanted to maybe close out the show in talking about ethics of this whole situation. Because I think I remember, I think it was in college where they gave us this ethical dilemma of like, hey, you could save one person, but at the expense of a large number of others. That's sort of your prototypical ethical dilemma. I feel like this is where we are right now, where we have the unfortunate passing of a baby that seems to be again, I know there's an investigation in progress, but.

 

that seems to be due to the administration of a probiotic supplement. But on the other hand, we have all these other groups of babies that are standing to lose the benefit. How do you feel from that more philosophical standpoint on this whole situation? Because it is not, because there are regulatory bodies that do have to make recommendations. So I'm just curious as to what is your gestalt of the whole situation?

 

Jonathan Blau (31:17.11)

This is a really important question, Ben, and I'm not...

 

Thank you for bringing this up. I think these are things that are in the minds of probiotics folks. Hopefully not too often at 2 a.m., but they do come up. It's really extremely important. Look, the case that we learned about in September, we don't know when it happened, was really such a tragedy. And as I mentioned in the last episode, there should be zero tolerance in our field for this.

 

But, you know, there are different types of probiotics that may have different outcomes, may have different, excuse me, risk for this type of, you know, tragic outcome. What happened though, we need to be clear, extremely rare. And again, I'm going to mention the JamaPeds article from September, the meta-analyses, over 25,000 patients.

 

and zero of probiotic associated sepsis. So I think we need to start there that this is extremely rare. And the next society, you know, as I had mentioned, they put their paper in response to the FDA discussions in September, they recounted that about 500 patients have died in the United States from neck each year. That's a tremendous amount.

 

Ben Courchia MD (32:16.974)

Mm-hmm.

 

Jonathan Blau (32:44.299)

But what I, you know, I don't think that your or my ethics on this really is kind of the best way moving forward. And again, the next society, we need to talk to our families. They are wise, they are smart, they are their patients' best advocates. We need to, what I would like to be doing in a year, I hope maybe sooner, maybe I'm being too optimistic, but what I would like to be doing.

 

is in whatever kind of consent process comes out of this, whether it all has to be written, whatever, when the dust all settles from this. I would like to be discussing with families that the risk reduction of neck appears to be about 30 to 40%. This is a terrible disease. The mortality rate is 30 to 40% overall. And then when it's surgical neck, it's higher than that. Survivors have a lot of challenges, but there is this extremely rare.

 

side effects, side effects is the wrong word, excuse me, there is this very rare but extremely tragic outcome that we can see and we need to talk about the numbers to best inform our families and we need to have the families decide. If I was a parent of a 23-weeker, I would want to be treated that way with that respect and given that choice not to have regulatory bodies or the neonatologist who's on call

 

make that ethical decision for me and my child.

 

Ben Courchia MD (34:13.058)

I'm going to let this sit and close the episode on this very important note. This was phenomenal, Jonathan. Thank you so much for making the time to be on with us today. Daphna, thank you again, as always, and we'll see you guys tomorrow for more episodes talking about Probiotics.

 

Jonathan Blau (34:29.931)

Thank you, Daphna. Thank you, Ben. It was a pleasure to be with you here today.

 

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