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#136 - The Giants of Neonatology Ep 6 - Dr. Barbara Schmidt MD

Barbara Schmidt Incubator Podcast

Hello friends 👋

We are so happy to bring you a new episode in our series focusing on the giants of neonatology. This time, we are featuring the incredible Dr. Barbara Schmidt. This was a very special interview where Dr. Schmidt shared her perspective on the state of neonatology and clinical research. We are purposefuly releasing this episode on July 2nd as it is for most newly minted nicu fellows their first week in our beautiful specialty. We hope this chat can be a source of inspiration and motivation for you all starting your journey in this amazing field.

Happy Sunday!


During the interview, Dr. Schmidt mentioned Dr. Pape's book, The Boy Who Could Run but Not Walk, you can grab a copy of this book here:


One of the articles mentioned in today's episode can be found here:

Schmidt B.J Pediatr. 2023 Aug;259:113488. doi: 10.1016/j.jpeds.2023.113488. Epub 2023 May 17.PMID: 37201684 Free article. No abstract available.

Schmidt B, Roberts RS, Davis P, Doyle LW, Barrington KJ, Ohlsson A, Solimano A, Tin W; Caffeine for Apnea of Prematurity Trial Group.N Engl J Med. 2006 May 18;354(20):2112-21. doi: 10.1056/NEJMoa054065.PMID: 16707748 Free article. Clinical Trial.

Schmidt B, Roberts RS, Davis P, Doyle LW, Barrington KJ, Ohlsson A, Solimano A, Tin W; Caffeine for Apnea of Prematurity Trial Group.N Engl J Med. 2007 Nov 8;357(19):1893-902. doi: 10.1056/NEJMoa073679.PMID: 17989382 Free article. Clinical Trial.

Schmidt B, Davis P, Moddemann D, Ohlsson A, Roberts RS, Saigal S, Solimano A, Vincer M, Wright LL; Trial of Indomethacin Prophylaxis in Preterms Investigators.N Engl J Med. 2001 Jun 28;344(26):1966-72. doi: 10.1056/NEJM200106283442602.PMID: 11430325 Free article. Clinical Trial.


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

Speaker 1 0:01

Welcome Hello, everybody. Welcome back to the incubator podcast. That is Sunday. We have a special interview for you today. It is with none other than the famous Dr. Barbara Schmidt. I had the pleasure of sitting down with Dr. Schmidt. And I was actually on vacation that week. So I was assisted by the incubators, co founder, Dr. Rooney Tom's, and it was a tremendous honor to speak to Dr. Schmidt. And we're very proud to reopen the giants of neonatology series with one of the greats in Dr. Barbara Schmidt. So for those of you who are not familiar with Dr. Schmidt, she's a professor of pediatrics and senior scholar in the Center for Clinical Epidemiology and Biostatistics at the University of Pennsylvania School of Medicine. She's also a staff neonatology in the Division of neonatology at the Children's Hospital of Philadelphia, and the University of Pennsylvania health system. It's a great honor. And without further ado, please join us in welcoming to the show, Dr. Barbara Schmidt. Dr. Schmidt Good morning. Thank you. Thank you for joining us today.

Unknown Speaker 2:06

Good morning, Ben. And good morning, really.

Ben 2:10

So, I like to start off these interviews with with, with people like yourself that have had such an amazing career. By starting with the origin story of your career in neonatology you trained in the late 70s When the field of neonatology was really still in its infancy. And I am wondering at that time, what was it that attracted you to this field of medicine specifically, considering there, there wasn't much of neonatology, then?

Speaker 1 2:44

Well, I consider myself as part of at least the second generation of neonatal specialists, we were already standing on the shoulders of giants who'd come before us. So yes, it was still as you correctly say in its infancy this field, but I was clearly not one of the first line of pioneers so we had people to look to and to look up to. And I chose neonatology in hindsight, during my pediatric residency, which was still in in Germany. Because of all the rotations, it was clearly the one I enjoyed the most, even though I enjoyed many others as well, but it stood out for me, primarily, because it wasn't limited to a particular organ system. It gave us the opportunity to be the sort of last generalists inside the hospital in acute care, other than maybe pediatric ICU, which was even less developed. So I did not seriously consider that. But that was I think, for me, the main reason for choosing neonatology.

Ben 4:09

You are You're famous for being an amazing mentor. I've spoken to some of your mentees and they and they, they only have great things to say about about you as a mentor and I am wondering since we're talking about your, your the inception of your career in neonatology, are there any mentors or key influences in your career that that have inspired you to pursue both neonatology and certain areas of research that you've that you've pursued?

Speaker 1 4:41

So to be perfectly honest, and maybe that was again, a sign of the times, certainly. I did not really have a single mentor who stood out in the sense that you and Your generation would understand what what a mentor does. I had role models I had people I could turn to for specific advice. As I said, I had people who I admired. I started really my outside of my residency in Freiburg in Germany. I started my neonatology training at the Hospital for Sick Children in Toronto. And that was already then in the early 80s, by but for several years for many years since the 60s, a very famous neonatal ICU. And when I did my fellowship training, that was the last years of pulse via who was originally an English man who had really started the unit, and he was just an incredible gentleman and a superb clinician, and also scientist. And I looked up to Karen pape, who probably do you still know of Karen pape, because he is an interesting lady, I will just briefly explain why I looked up to her. She actually is somebody who essentially dropped out of mainstream academic medicine. And she was an iconoclast, she turned a lot of cherished beliefs on its head. But to put things into perspective, while she was still in neonatal consultant at the Hospital for Sick Children, when when I arrived and during my training, and to just put her on the map. So you understand, she has actually done enormous things for neonatology that most people probably are not even aware of, because you know, people get forgotten very quickly. So she had written a very famous book at the time that should be still famous on hemorrhage, ischemia, and Perinatal brain together with an eminent London based pathologist, and really, in this book, that it was really the output of her postgraduate studies in London. She put basically, the mechanisms that lead to these brain injuries on the map. And much of what's in this book that was published I think, in 79, or something is still valid today. So it's a classic Well, perhaps more impressive for you guys's she was actually the first, the absolute first based on publication sequence, who introduced the world to the feasibility of detecting brain damage with ultrasound through the anterior frontal now, it was simply a letter to the lancet at the time. But she was the first and then she dropped out of academia and worked on the sidelines. She also had neurocognitive sort of training. And she before her does, she wrote a book that I think you young guys should all read. It's called the boy who could run but not walk. And in it, she turns everything you've been taught about cerebral palsy on its head.

Ben 8:13

I'm gonna look that up right now. Yeah, so

Speaker 1 8:15

she was somebody who I had on still have enormous admiration and respect for, because at some level, not to the extent that she was, but I've also had a bit of a rebellious spirit and challenging prevailing opinion and dogma, that, that, that I always like to do myself. Mm hmm.

Ben 8:41

And so you're crossing the Atlantic from Germany to to North America, to do the fellowship in Toronto. And I am just curious as to what prompted you then to not go back to Europe and sort of pursue a career in North America? What were what were the factors that came into that decision?

Speaker 1 9:04

Well, you're absolutely right. And I have to say, I never really formally immigrated, right. I came to Toronto for postgraduate studies and then my fellowship. And I actually had a job at the University Children's Hospital in Freiburg to go back to and I wish I could say it was science or, you know, the hospital or all these things that made me stay but it is much simpler than that. It was that I met my husband. I think you know, him Harish Kripalani in my first you know, few weeks on the neonatal ICU and and, and then Canada and Ontario became, since we both neonatologists both looking for a good job, became a very good place for us to to do that.

Rune 10:01

Yeah, those things happen for sure, very quickly. But, but one thought I had to which I find interesting when we, you were telling us about caring puppets, kind of the people that influenced you along your career and, and have really a profound effect on maybe even how you perceive neonatology and how you how you practice, I think, correct me if I'm wrong, I feel as though there's a slight decrease in the collaboration across the Atlantic because I mean, at even at that time, the Central European neonatology was a growing field as well. Where do you think that kind of collaboration between the Europe and the US and other countries where are we as improved? Or has it, you know, stayed the same?

Speaker 1 10:51

You know, I'm not sure I can really give an authoritative answer on this. I can only say that in my own trials. Certainly the caffeine trial. And also, the oxygen saturation targeting trial, one of the five trials that I was leading. If that were the Neil prom collaboration, so called the Canadian oxygen trial, we, we always had European sites involved, they were all international trials. And they went across the Atlantic, and they went across the Pacific. And quite frankly, these were all trials, we didn't have a formal network, right? They were trials of friends and friends of friends. So I hope that there isn't a decrease, I hope that you're not. Right, that that there is a decrease, I've just noticed that some of the output seems to shift a little bit. I think the Europeans is a big generalization, but I think they were a little bit late to the, you know, organizing themselves into big Pan European tribes, which they are certainly now doing more of, but I think the same is true in Australia and New Zealand, where we also see a lot of output and a lot of trial activity. And some of that crosses the oceans and, and some doesn't. We're sure.

Ben 12:32

It's interesting that you mentioned some of your trials. I mean, as we as we were preparing for this interview, that you've you've been such a prolific researcher that it's hard to decide what what to ask you about, but I wanted maybe, to start with the with the cap trial and your work on caffeine. And I am wondering if you could actually walk us through the inception of the cap trial, specifically, how the field of really neonatology worked its way towards this new quote, unquote, drug that was much better tolerated than the alternatives at the time, like, the often. And what was, I think it what's interesting to me is that, at the time that the cap trial starts off, people are using caffeine, and what was the reaction of the community towards the trial of caffeine for long term outcomes.

Speaker 1 13:27

So you, you are right, people were using I was using caffeine, it was in our cookbooks, even. Even though it wasn't licensed in Canada, it wasn't really licensed anywhere. It just not even while we were starting to think about the trial, I think the actual US FDA license came in 1999. And I actually got the FDA hearing documents under the Freedom of Information Act to incorporate into our grant application. But it was an old drug. It had been around since the 1970s, and publications on its pharmacokinetics, and so forth. Very small trials made mostly counting up now as an outcome had been had been around. So why did we do the cap trial? That is basically your question, right? Or how did we come up with this notion that this trial should be done? So I tell you this, I

Ben 14:31

think I think that's more than that. That's more of my question. I think I understand why the cap trial was done and why it needed to be done. But I am just, I'm just curious about how what was the general feeling like about the need for the trial, as we are talking about a medication that was gaining in popularity at the time, and I think when something is being used and seems to be working, it feels like Well, should we just keep going well, it looks good, too. works, why why the need for the trial? And I'm just wondering what was the atmosphere like in the field of neonatology when it came to, to the inception of the cap trial?

Speaker 1 15:10

Well, I think the the the easiest answer to tell you what the initial response was, was to cite my own husband to thought I'd gotten crazy. When I floated the idea with him of doing placebo controlled caffeine trial, in, you know, in 2000 babies. So what happened is, and, you know, before I had started to dig into the literature, and what we actually knew about this drug, I would have responded the same way. Oh, well, you know, it reduces apnea. And so what's the problem? But I learned very quickly that, you know, once you presented the evidence, or rather the lack of evidence on its efficacy, beyond counting apneas and on its safety, and why there should be concerns about the safety to people, they change their mind. And so I in a nutshell, equity poses not a synonym for ignorance, right? So once people understood what the evidence actually was, and what we knew about the potential balance of risks and benefits, many not everybody, of course, but many people came around to the point that, you know, quite a few, there was 35 centers internationally in the trial, voluntarily joined the trial, because as I said, it wasn't a network where you had to do the trials that were going forward. So the interesting piece here is that the parents, once we started with a trial, and I did a lot of the initial consent discussions myself, as well. Parents immediately understood that this trial needed to be done once you expand, and the more informed they weren't the more educated, the more easily they understood, because once you explain to a parent to offer off a very preterm infant, that you're giving just as a loading dose, a caffeine dose that is equivalent to six cups of good coffee, good strength coffee, they are horrified. Because, you know, during the pregnancy, they've been told that maybe you know, a cup is okay, but not too much. Don't drink too much coffee. And here we go and load them up, right with very high doses, even if you're referred to the standard doses. So the parents were actually the ones who many signed up because they were hoping to get placebo.

Ben 18:00

That's really chose to hear that. That's, that's crazy. And so I wanted to highlight a paper that you're publishing. That's, that's online, actually, right now ahead of print in the Journal of Pediatrics called medical progress. Caffeine for apnea of prematurity, too much or too little of a good thing. I really enjoyed this paper. And in there, you say, and I quote, very low birth weight, infants should only be considered for caffeine therapy soon after birth, if they one are extremely immature and receive positive airway pressure without an endotracheal. Tube. Number two, our winning from medical ventilation, mechanical ventilation towards a trial of extubation, or three have documented apnea. What do you think, Dr. Schmidt, about the therapeutic drift that has happened since the publication of the original caffeine studies where some of us as clinicians perceive that because the evidence that's available, we can reasonably then assume that more caffeine given sooner for longer? Must be good?

Speaker 1 19:10

Yeah, I mean, I think if you say if you thanks for referring to that paper, which as you say is is is pre proof right now. I wrote it because I'm very concerned about about this drift. And because it's human nature almost and it's not the only drug to which this has happened that if something works more must be better is is is the sort of often the way people operate. But if you speak to people who understand the pharmacology of this drug and They are very concerned. So for example, Jacaranda whom I quote to who's really Mr. Caffeine, I mean, he did all the original studies in out of Montreal in the 1970s and early 80s, the pharmacology and so pharmacodynamics they are very concerned about about higher doses than the ones we we tested in the cap trial, because the mechanism of action is, as a respiratory stimulant doesn't necessarily require these higher doses. And these higher doses have potential consequences that are very hard to predict. I'm not saying that higher doses are going to be unacceptable from here on, I don't know, but the right studies haven't been done to show that they are both more effective and safe. The research that is out there, if you, you know, there was actually a recent Cochrane review, I think it got a fair bit of traction also in in the social media and your Twitter accounts that that young people are using. And it concludes that it reduces PPD well. So it included actually trials in which I mean it, it said there were six trials that they included, but that included trials that in the control group use less caffeine and standard dose. So what kind of comparison is that? Right? already used? Even though they said they wouldn't include those, it did include one trial, we're only the loading dose was higher. And then that's the St. Louis single center trial, right. And then the maintenance doses were the same. And so I don't know what one is to make of just one single loading dose being higher. So I didn't include it in in the table in this paper, when I looked at this evidence, but so you're coming up with very few babies who have received these higher doses. And then these higher doses are not just one higher dose, they're all over the map, right? The loading dose goes from 20 to 40, to 80. And the maintenance in some cases, while it goes up to 20. So double what, what we have used, but they are not all the same. And the other problem is the children who have the most apnea because of the immaturity of the micro preemies, right, the extremely preterm babies, and these trials didn't really include those

Unknown Speaker 22:51

as important. So So I think,

Speaker 1 22:52

you know, it's it's something that that does concern me, I it concerns me, as long as people don't do the right trials, and get to the bottom of this question, it is a question that needs to be answered. For sure. It may well be that it's better, but we just don't know.

Rune 23:13

It's an important discussion for sure. And I guess, you know, it's such a commonly used medication and we as needed to just it's just something that we have in our in our pockets and use every single day. Maybe that's why we have fields or we have the freedom to go. What however, what do you think about the potential kind of anti inflammatory effects of caffeine itself limiting the potential neuroprotective aspects of it?

Speaker 1 23:45

It may be, but again, I think the evidence we have for it so far is it's not sufficient to use it for that indication. And, you know, the more we looked at the data in the cap trial, typically then with post hoc analysis, of course, but the benefit that we see even up to 11 years in motor impairment, right, the reduced motor impairment, much of that potentially all of it based on the confidence limits could be explained purely by the action of caffeine as a respiratory stimulant. Because the single variable that that predicts so much of this improvement on motor impairment is the reduced time on positive airway pressure, any type of device that delivers that, that is really such a powerful predictor, and it is more predictive than time on oxygen. It is more predictive than time on intubation. Now, you could argue that that could also It'll be an anti inflammatory effect and not, you know, but but, you know, I think if we think about why do kids fail extubation? It is first and foremost because of apnea and periodic breathing. Right? Why do they fail coming up? CPAP? Not because they have lung disease and some inflammatory process, but because they don't breathe enough, right? Yeah, yeah.

Ben 25:28

In that same paper, you you mentioned something that I had not really considered up until I read it, which was some of the inequities that are prevalent worldwide when it comes to the availability of caffeine in low and middle income countries. In that paper, you mentioned that you conducted an informal survey of your international colleagues. And so I am wondering if you could tell us a little bit more what those discussions were like. And what exactly is that disparity that is still happening today, despite caffeine being now quote, unquote, such an old drug in low and middle, middle and low and middle income countries.

Speaker 1 26:10

So this is again, something that has, has upset me and I've been thinking about and talking about, informally, for a number of years. And, inevitably, when you talk about the trial, I mean, you talk about caffeine, and you know, I've been traveling a fair bit of over the years, speaking and in on every continent, basically, about caffeine, and apnea, you will learn very quickly from your audience, what the problems are. And it the problems range from not having any caffeine in the country. That is getting a little less common, but there are still totally, you know, white spots on on on the Global Map. But where it is available, it is often unaffordable. And it's not just happening to me. I think I'm allowed to quote because I have recently my former boss at Children's Hospital of Philadelphia chop Eric Eichenwald, who's obviously also, you know, very knowledgeable and interested in apnea just told me recently that within the last few months, he gave a talk, I believe it was somewhere in Central America, I believe it was Panama. And he talked about apnea and caffeine for an hour. And only then people in his audience told him that they can't actually use it because they can't afford it. And to be perfectly honest, I've met people in the states who say, it's very expensive. So I don't know really, I haven't explored that in great detail, but it's certainly prohibitively expensive in in many parts of what I called in the paper, middle and low income countries. Or it's only available or people only in private hospitals, but not in publicly funded hospitals can pay it or the parents are required to pay it. And of course, often can't.

Unknown Speaker 28:33

Yeah, that happens often, doesn't it? And

Speaker 1 28:35

so I think this is something that needs to be addressed.

Ben 28:40

This episode is proudly sponsored by rocket meat Johnson. Recognized Johnson is dedicated to the research and development of nutrition products that help support baby development at every stage, including an extensive and female portfolio for premature and low birth weight infants learn more at HCP dot meet You've written like I said before on so many different pathologies and therapies, but after reviewing your body of work, Dr. Schmidt, I mean, I think one of the things that do come out is, I think, in my opinion, at least a deep commitment to neurodevelopmental outcomes of preterm neonates right. And you've written extensively about research methodology as well. I am curious about what is your assessment of the way in which nerado metal research is conducted today? What are we getting right and what are we getting wrong?

Speaker 1 29:36

Okay, so, um, we chose in the end for the indomethacin prophylaxis trial already and then certainly for the caffeine trial and later for the oxygen trials. This outcome 18 months at the time, of death or disability because So we were in each case, examining the safety of a therapy that was already in use right in prophylactic indomethacin, the same thing people were using it. Especially in the US, it was I think most commonly used there. And it has obvious short term benefits. And we didn't set out to refute that we knew it reduced PDAs symptomatic PDAs. And we knew it reduced severe IBH. But indomethacin, given to, you know, kid under a keylock in the first 24 hours of life is a very powerful drug. And we did the indomethacin trial, the tip try with this long term outcome, again, to examine the safety of this routine approach, because the moment you talk about prophylaxis, you even have a greater responsibility to examine safety. Because inevitably, for any prophylaxis, you're going to expose a lot of babies who don't stand to gain anything. So with respect to what really matters here, the ivh right. So I mean, in the tip study, 13% in the in the control group, and 9%, roughly, in the in the treatment group got severe IBH. So the vast majority of the kids who were exposed and now even those rates would have come down typically in today's neonatal ICUs if they do a good job. So. So the vast majority, even then, of kids who were given prophylactic indomethacin, didn't even benefit because they weren't destined to develop severe IBH are they were among the group, the two thirds who get treated and still develop severe IBH. So with something like that, you have to ensure that such a powerful drug that doesn't just work in the brain or on the PDA, but also works on the kidneys and all sorts of other organs, that it is safe. And that data, again, was just not there. So that's why we designed the trial that way. And caffeine, we already talked about the background, why we did it? I I do believe that Disability Matters. I also believe it matters to most parents. I know where I think you're going with this question because there is a lot of debate sometimes quite fierce debate right now whether, you know, parents would agree with certain components that we combined in this outcome of disability, things can we Things can always be improved upon. But we have to be very careful that in this debate, we don't end up throwing up the baby with the bathwater. The first thing to say is when you know, did we in the 1990s, when we designed tip, and when we designed cap, both of them were designed in the 1990s. No, we did not have a formal process where we consulted parents about these outcomes. We will actually I think arguably the first with the tip study, I'm remembering this correctly, who actually had such a long term outcome as a primary outcome. But you know, it's absolutely right to have discussions with parents. And it's critical nowadays in 2023. But parents don't agree with each other. And I know that I've been a clinician and a very consummate clinician on my life. And I know parents who, you know, who will cope with everything, every outcome and others. Not at all. And families have different values, and how are you going to get around that issue of variability among the parents who you're going to listen to? So at some point, I think this current debate is getting to me a little lopsided, as I'm following it. I don't know where you stand on on this. But I think just because some parent says cerebral palsy doesn't matter doesn't mean cerebral palsy is a desirable outcome, right?

Ben 34:34

No, I agree with you. And I think you're you're putting your finger on the on the post. They're aware. How do we get a consensus opinion of parents that is both both a consensus but also representative of a very diverse group of people? That's not really where I was trying to get to with that question, even though I have questions about like counseling and things like that, but I'm wondering what I'm going to I guess try to clarify a little bit when We are looking at neurodevelopmental outcomes, right we've we've sort of agreed as a field that the Bailey is sort of the standard, and that this is how we measure outcomes. And, and I think that it's now part of the framework of how we evaluate neuro development. But it's still, to me sometimes feels like a very imperfect science. And so I'm curious about and obviously, the ideal way to assess the neurodevelopment of a child is to follow them up to like four or five years and and that has its own set of problems with retention and making sure that you don't lose too many patients to follow up. And so I guess I was I was asking you more from a research methodology standpoint, the way in which the tools that we have at our disposal to measure long term outcomes? And and do you perceive that, that what we have right now is sufficient? And and if not, where do you what what are you hoping that we can reach as a field in terms of optimizing how we measure neurodevelopment?

Speaker 1 36:03

Right? Yeah, that's a very important question. And I do have, perhaps even a provocative, developed a provocative view on this. You're right, the Bailey is very imperfect test. And it doesn't help that it radically changes from one edition to the next in terms of what it actually measures and how it is calibrated. But I would go and guess you're right, the longer you follow, the more you the more reliably you can determine cognition, for example. But I would actually go beyond that and say, certainly, as a primary outcome, I would not, in future even include cognition, I would focus on motor function, and where we're appropriate vision and hearing, although these are thankfully nowadays, low frequency problems in most of the populations that we study, why not cognition, because as long as we live in an in unequal world, in most parts of the world, the cognitive development of a child is particularly as the child gets older, heavily, heavily influenced by the environment. And we have seen that in some of our data in the cap trial, and many other people, I mean, the socio economic factors and social advantage or disadvantage, have such an enormous influence on cognitive development. And unless you work in a system, where much of that gets taken care of by state funded high quality very early, kindergarten, and schools that sort of reduce the impact of these disadvantages. I think we are not really measuring biologic effects by the time we measure cognition. Later in childhood, we are measuring more of, you know, the environment in which the child grew up, you know, these huge differences in children who grow up in affluent, educated environments in terms of how many words they speak, by the time they are three or four years old. I mean, it's just enormous. So I personally think cognition is is an iffy outcome for that reason, if we really want to measure the impact of our Neonatal Therapists. Yeah.

Rune 38:38

Wow, that's excellent points. I mean, it just goes to show how complex the feel that were that you've been studying is and how complex outcomes are. Just to piggyback on that a tiny little bit. I mean, you've been part of you said, You're the second generation neonatologist, I would almost call it maybe somewhat of the golden age of neonatology in the sense that you participated in a tip trial, the cap trial, the kind of trial, these large randomized control trials. How do you actually see the future research in neonatology is and more of the same of these large trials? Is that should that be the goal? Or should we rethink some degree of research strategies, study design, invent new tools, such as maybe virtual patients and predictive models on on on on the studies that have already done what do you thoughts around that?

Speaker 1 39:33

Well, we certainly shouldn't keep doing what we've always done. There's always room for improvement and and there's always going to be ways to do the to do the studies and the trials more, you know, in a smarter fashion. The one thing I would like to say is, I hope that people don't stop doing it. experimental research and I obviously count randomized trials, those that experiment among those, because doing, you know, people, some people have this notion that with mega data, you know, you can you can answer every question. But I think we need, we need observational data, they absolutely, absolutely play a role, but they're not sufficient to answer all the questions that need answering. But as for the trials, I think, you know, ironically, the pandemic has shown us some ways of how things can be done when, when there's a will, and when there are the resources put against it, to do them, you know, platform trials come come to mind. Obviously, they have their limitations as well, and people will find out more than are already known, but it's a very attractive way to, to answer more than one question at the same time. I'm sure there are going to be and there are already all sorts of innovations. And quite frankly, yeah, were we in a golden age? I don't know, we didn't, we didn't see it like this at the time. And but perhaps the sizes of the treatment effects, or the difference we could make was perhaps a little bit bigger than now. It's more like, even more incremental than then it was already, then. I sometimes think, but at the same time, you know, you talked about mentees, Ben, that you've spoken to when I look at just you know, the the young people we had the privilege of working with in Philadelphia, and I could name right off the bat for people at least it's actually very heartening to me to see the kind of work they now to as and launched and succeed doing as now independent investigators. So that gives me a lot of faith in in in the future of neonatology actually, because they will also then again, train a next generation. Right? We're sure.

Ben 42:30

This is my question for the Dr. Schmidt consult. I have you've had a career that has been stellar. And I am wondering, when we are all there's some there's some commonality to your career in our career, in light of the questions were being asked by parents and, and inevitably, parents will ask us, Well, my baby be okay. Right. Well, how will my baby do? And, and we and how we counsel families? In light of this specific question, when it comes to long term outcomes is very difficult and is an is something that that skill comes with experience. I am wondering, what are your tips? And what is your approach to counseling families, knowing what you know today about the long term outcomes of extremely low birth weight? Babies? What do you tell these families when you're in the NICU? And how how do you how do you modulate the your counseling based on the data that we have without being too optimistic, not too pessimistic and so on.

Speaker 1 43:41

So the all of this, of course, requires always having established a relationship or working on establishing a relationship with the family. And that includes working out who they are, what their values are, what they want to know not what I want to tell them, but what they want to know. And listening is is as opposed to talking is a big piece of any consult. The next point I would make is that what you say and answer even to specific questions, changes over time. Right. So before delivery, it's a completely different set of numbers. Then, after delivery, because you now know that the baby and outfits an extremely preterm baby has already come safely out of the delivery room, which you didn't know necessarily before delivery. And then as the child gets older in the NICU, the the the The mortality risk obviously declines because most of the mortality is early on right, and then sort of declines. It doesn't go to zero, but it declines. But as far as long term outcome, and that's another piece that we've been working on. It then depends on how many what happens to the baby in the NICU and how many complications and how many morbidities, the child suffers, right. So the child that goes through without developing BPD, without developing serious ROP, without significant brain injury has a much better even all other things being equal, gestational age, even gender. And birth weight has a very different prognosis than one who manages to pick up all three. So. So that's with respect to that eternal it's not one type of outcome for a particular baby it even for that single baby changes over time. As I said, with the families, I never have just apart from a single antenatal consult where I may not necessarily have been the attending later on. It's it's always more than one conversation, right. And also, it's a mix of all should be a mix of talking to parents directly at the bedside as you pass by or during rounds, as opposed to having formal sheduled quiet and as you know, separate room or something. sessions with them. And as for yes, do I talk about long term problems? If it absolutely or did I should use the past tense of course. And I think parents appreciate the combination of empathy and honesty. And they recognize it very quickly. And one of my formative experiences, even though I was definitely already relatively senior, was actually an experience in Philadelphia, where I came on, relatively late in the course of an individual child who had had a very rough and problematic cause and was already at least two months old, and clearly had a very concerning prognosis. And I was now inheriting this child as attending from my colleagues. But I felt I needed to make sure while I was looking after this family, for the next two weeks that there was actually a single mother that the mother had a sense of what was ahead of her and her baby, which I wasn't sure was the case. So I tried to. I booked a meeting and she was at with our social worker and the bedside nurse the way it usually sort of was arranged. And she was very reluctant to even agree to the meeting and said, she didn't really need a meeting. She didn't she knew everything. She had updates every day. Yeah, she knew how much oxygen, you know, what the ventilator said, because the kid was still ventilated, what the ventilator settings was, but I said, Yeah, I know, all I know, you know, but it's just I want to talk about the big picture. Anyway, fast forward when she finally did come. And the dynamics were that she was sitting at the extreme other end of the room and was really, almost hostile for the first 1015, even 20 minutes of what turned out to be at least a one hour conversation. And fast forward. And by the end of the conversation, she came up and gave me a big hug, and said, thank you, for for, for helping me see. See it this way. And so that's why I'm saying, you know, this is just one single experience, but there were many similar ones, maybe not quite as dramatic, but people appreciate and they sense you know, whether you are caring about them, but also whether you are telling them the truth as much as you know it themselves that you also need to be able to admit what you don't know. And the uncertainty of everything you say, you know, you never ever, ever say your baby won't walk or talk, because you don't know. Nobody ever knows that, huh? Right, none of us. Yeah, that's true.

Ben 50:05

And to follow up on that question, and I'm sorry for for the tough questions, but I feel like we are well into our interview. So I feel like I have the right to ask. But our, our field of neonatology has really shifted I feel like from its its early years, especially in the in the 60s and 70s, where really death was something that was prevalent to a situation where our survival rates are really quite remarkable. But instead of really struggling with mortality, we have to talk about these things of long term outcomes. I am wondering, Dr. Smith, how has your perspective on life and death in the NICU evolved over the course of your career? From from when you were a junior attending to when you were closer to retirement?

Speaker 1 50:52

Well, yes, mortality rates have changed and disability rates, not really. The so I don't think you put me on the spot a little bit, Ben, but I don't think my view on on those two outcomes, this and disability in itself itself has changed so much. I've always so I you know, I don't talk about this very often. But my own sister died soon after birth. At at 38 weeks, when I was seven years old. So I know firsthand what a death of a baby means in a family. And how a family in some ways never recovers from that trauma. So death has always been important to me. But so has disability. And I haven't personally in the family experienced it, but I've seen many, many, many families struggle with it. Some, you know, coping better than others. So I think both outcomes still matter. And, again, you know, you you hear now that, you know, death is all important. And and there are you know, people who say parents are basically don't care about disability that that concerns me, it also concerns me see that people want to push the envelope ever further. And, you know, first it was, well, when I was training, it was 26 weeks or maybe 27 weeks. And, you know, we reasonably brought it down. I think the push now to basically offer care to, to virtually all 22 weekers does concern me because I have not seen outcomes that would justify that. And I think before one goes into that gamble with a family. They need to be, you know, we don't even have enough data to inform them properly. That's the problem. So I'm watching that now from the sidelines. I'm not, I'm not in there to have to, to make to be to be part of those decisions. But

Unknown Speaker 53:32

I, I do believe that there is a bit of a crusade going on right now.

Ben 53:39

What do you say, then? I'm going to be devil's advocate, just because I'm curious about your your answer. What do you say to people who are advocates of of pushing the envelope, as you say, and who are arguing that what we are seeing now, especially with high mortality rate, high rates of of disability, that these are the growing pains, and that over time, our outcomes will get better? Because that's what the field has shown that outcomes have gotten better for every gestational age group over the years. And so those 22 weekers, in a few years will have much better outcomes.

Speaker 1 54:13

Well, as long as they have that same conversation with the family, you know, you may be you're right now in that, because I think it's a difference if you push the envelope at 2726 or 25 weeks then pushing the envelope at 22 and maybe next 21 weeks because I mean the developmental stage is just getting you know, so extremely different and also the technical difficulties of you know, intubation may not maybe be the easiest of them to find reliable access, you know, venous access Uh, for for these children. And I think if you have if you if you have those honest conversations I mean years ago I was part I was still at McMaster and in Canada when we knew we were looking after 20 267 weeks infant because the parents insisted. And we knew it was exactly that because it was an IVF pregnancy and has the child done? Well, not so much but survived. But, you know, that family was very adamant after all the information we could put to them, including that we'd never looked after a baby quite this immature. So that's okay, as long as the healthcare system can come up with the funding, because that becomes super expensive. It also ties up bids and resources and MC cues that are often already operating at the limit, right. But I have a feeling right now maybe I'm interpreting it incorrectly, that there is sort of a bandwagon going around that more and more people like some colleagues tell me that they feel pressured to, to, to jump onto this bandwagon.

Ben 56:28

I appreciate you you're giving giving the the sense of Winnie I'm going to

Rune 56:32

say what you just absolutely fascinating discussion. I agree. And I think this is a conversation that needs to be going ongoing. But also I was going to say then how do you indefinite ever end these podcasts, interviews with with the greats.

Ben 56:48

So we try, we try to jump on lighter topics, which I have already. But because I thought if I asked some of those questions early on, this was going to be a doom and gloom podcast. So I left them for for the second half of it. I wanted to ask you one thing is that when I look at your career and the number of publications, and not just the number of publications, but the quality of the work you've done, I think it would the question that we have, I think for me, and I'm sure for other young attendings, how do you balance everything, whether it is life, whether it is work, and still yet achieve this consistence is consistent excellence throughout your work? What are your What are your, your tips that you can share with us?

Speaker 1 57:33

So, the first thing I need to say is I've been very fortunate in, in in many ways in in that I have been able to have positions in superb institutions, and been able to have protected time. Through, you know, in the US, of course, you have to buy your protective time. But for that you have to first buy it right. So you have to succeed with the grants, which we also but I also had an endowed chair in Philadelphia, so that helps as well. So again, I've been very fortunate in that regard that I had, what I consider just the right balance between all three, I truly did all three clinical service teaching, which was for me inevitably connected with clinical service also. Because I was always teaching trainees and of all types and you know, in academic hospitals and research. So So that's the first thing to say. The second is that in a way, it has obviously some downsides too. But being married to another academic neonatologist has also been helpful in in many ways because you understand each other you understand when people are tired, you understand when people you know, need need the quiet time, but you also can bounce things off and even the politics sometimes. And so you can travel now we've mostly traveled together because people tend to invite us together. So we've been in many ways, very fortunate. Work life balance. It's very simple. We don't have children. And we chose that was not an easy decision. But we chose many years ago that We were we had no family in Canada and North America anywhere. We were both in neonatal intensive care. I mean, if one partner has a job that is more flexible and adaptable, that may make it a lot easier, right off the bat. But we both wanted to do academic neonatology. And the models I had seen of having your kids raised by au pairs, or nannies who sort of rotate through the household wasn't attractive to me at the time, either. So that was, if you will, our sort of sacrifice. Although we made a very conscious joint decision in that way, I don't think that that one can have everything, sometimes, you know, you have to make difficult choices. And I know people, young women in Philadelphia, some of our trainees who are fantastic academics and have lovely children and manage to combine it, but the circumstances may be different, the spouse may have a different job, the family support, maybe in at least within the same continent, and so forth. But that is sort of where I would see ourselves Harish, and me having that sort of our concession to, to our academic careers.

Rune 1:01:31

I yeah, I was just gonna say, I'm looking over your CV, like Ben said, obviously, they're very impressive everything you've done. And throughout the I noticed, about five years after finishing your fellowship, you got your master's in Clinical Epidemiology and Biostatistics and a lot of our listeners are trainees or early career, how important you feel as though it is to pursue additional training, in order to do the type of work that you're doing, whether it's a master's in, in, in ethics, masters in epidemiology, public health and such.

Speaker 1 1:02:11

So it depends, I think, whether or not you need an additional degree depends totally on what you want to do. So if you want to go into administration, and that sort of thing, maybe an MBA is one way to go. If you as you know, want to do primarily education, there are masters in in that area as well, for me, you know, and McMaster was, at the time basically, where evidence based medicine was born, right. So it was an absolutely fantastic time. And there weren't that many people and because it wasn't available. Now, many people do master's and clean epi and statistics, but and basically all our trainees who want to do clinical research in Philadelphia have done it. But in our generation, you know, McMaster was one of the first places where that was even possible. And we did our degrees, we started them in the mid 1980s. So for me, that training and the environment, at McMaster in that department was a revelation was an absolute revelation. And without it, I could not have done the trials, I was actually starting in a completely different research track, doing actual whole animal studies and things that I was doing because it was connected to the work I've done in Germany for my MD thesis, but I wasn't happy with where that was going, even though I had grand support for it and everything, even a career award. But I had always been both in Germany in my pediatric training and also at sick children's in Toronto, I had always been uneasy about, you know, dogmatic opinions and you know, seniors who would say on rounds, in my experience, this is what we need to do kind of thing without providing any sound evidence. So I was always uneasy with that sort of approach. But I didn't have the tools to challenge it intelligently. And the first thing that happened with the training at McMaster which then ended in the in the Masters of clean epi was that it gave me a toolbox to ask questions more intelligently. And then, of course, I got into the environment in which it was possible. And with that training Due to design and run the trials as we did, I couldn't, I couldn't have done it without that training and without that environment. So it you know, whether people should pursue extra training to get back to what was really the core of your question depends totally on where they want to go. And for many people who want to be good clinicians, and look after babies and do a good job may not be necessary at all to to do an extra degree. It depends right on on on the

Rune 1:05:38

analogy of toolbox. Are you building your toolbox for the path that you're pursuing? Excellent, thank you.

Ben 1:05:47

Dr. Smith, our last question for for this interview will will will be related to that in terms of the trainees and the young faculty listening? You're such a great mentor for for people embarking on this journey. What are some of your advice in order to fulfill the passion and be successful?

Speaker 1 1:06:11

Are you asking specifically the path of a clinical investigator of a clinical researcher or? Edna,

Ben 1:06:19

I think I think, more general, more of a, of a general sense of embarking in the field of neonatology which is a field that is stressful that is demanding. And I think that applies to both academia and clinic. I mean, it's demanding in every aspect of it, I think if you are a researcher, conducting research in neonatology is extremely difficult. If you are a clinician, it's a field that takes a significant emotional toll on you that has high expectation, there's very little margin for error. So I think, for people who are embarking on this journey, and who are early in their careers, I'm just wondering if you have any pieces of advice as we as we close out this interview?

Speaker 1 1:07:01

Well, the obvious first answer would be that you know, even if you're served to something by the time you you and your fellowship or something you have at least 30 plus years, if not more in the US people don't seem to retire, I've noticed. So you have, you have many years ahead of you. So you better enjoy what you're doing. Right? You cannot embark on such a path for reasons of oh, it's paying well, or, you know, I mean, that helps if it's paying well, but the main reason has to be that you enjoy what you're doing. So regardless of what exactly that is, in terms of is it purely clinical? Is it a mix with education, administration, research, what have you. And the second piece of advice would be don't be afraid to change. And to reverse course, if you run into an obstacle that seems insurmountable. I mentioned that I was actually on a completely different trajectory with my research in in sort of Hematology applied to the newborn and lab based. And it was getting to the point that I had learned these techniques for my doctoral thesis 10 or so years earlier in Germany, but I couldn't come up with meaningful questions to answer in the baby. And that's a problem, right? So I changed track against the advice of quite a few people when I was already over 40. So I wrote my first big trial ground for what was then the Medical Research Council of Canada and is now Canadian Institutes of Health Research. When I was almost in my mid 40s. So it's not ever too late to change when you find that you're stuck. Because just imagine you do this, what you don't enjoy and what you feel is a dead end for another 20 or 30 years. And the last piece of advice that probably every program director in in the country will, will come down on me for is I was once in a big meeting with a lot of fellows in the room. And I got a lot of laughter when I said I never had a five year plan. And I never did have a five year plan. I I had a sense of you know, but this minutiae or Oh, that people expect people to fill in the blanks when they can't write and how can you decide what research you want to do when you just start in neonatology and so, yeah, I honestly never had a true form of five year plan. And that doesn't mean I didn't have a sense of direction, but nothing too. too detailed at all. Yeah, I changed country and, and institution at age 55 When I moved to Philadelphia as a full professor, so don't be afraid to change. Yeah,

Ben 1:10:41

I love it. Thank you. Thank you so much, Dr. Barbara Schmidt, thank you for making the time to be with us on the podcast today. It was a very enlightening interview. We wish you the best and thank you so much, Rooney. Thank you for CO hosting with me today. I had a great time.

Speaker 1 1:10:56

Thank you. Thank you. Thank you. Bye bye. I

Ben 1:11:04

thank you for listening to the incubator podcast.

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