#157 - Journal Club - 📑 Feeding protocol, treatment of pneumonia, transcatheter closure of the PDA and more

Journal Club is back! Daphna and I reviewed some of the latest papers published in the neonatal literature. This week, we talk about feeding protocols, treatment of pneumonia, transcatheter PDA closure, and much more.

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!

Transcript

Ben Courchia MD (00:00.598)
Hello everybody, welcome back to the Incubator Podcast. It is Sunday and Journal Club is finally back. Daphna, how are you?

Daphna Yasova Barbeau, MD (she/her) (00:09.743)
I'm yawning, but you're the one that's post-golf.

Ben Courchia MD (00:13.258)
I'm excited, I've been missing Journal Club, I have to say.

Daphna Yasova Barbeau, MD (she/her) (00:15.003)
I know you have, you've been talking about it. We didn't really miss that much Journal Club, but we had a special event with the CHNC coverage and so it's nice to be back to Journal Club. You're feeling that itch, you hadn't read a paper in a while, is that why? Yeah. We've been reading, yeah. Yeah, I mean, the folder is full. Full.

Ben Courchia MD (00:26.462)
Yeah, I'm enjoying journal club, so I miss it. Anyway.

No, the thing is that I read the papers and then they stack up and they're like, oh my God, we have to talk about this. Yeah. Full. So anything that we need to talk about before we begin Journal Club, you think?

Daphna Yasova Barbeau, MD (she/her) (00:49.695)
Um, we'll remind people that the next iteration of the Delphi conference is September 23rd to 25th, 2024.

Ben Courchia MD (00:58.426)
Yeah, mark your calendars and agenda is coming soon. If you are following the probiotic saga is continuing. I think it's important for people to know that the FDA issued another, I don't know what you call these memos, statements, warnings, reprimand, demerits, and this time for Abbott Nutrition Lab about their probiotic product. So it's interesting because

Daphna Yasova Barbeau, MD (she/her) (01:00.625)
Mark your calendars.

Daphna Yasova Barbeau, MD (she/her) (01:19.556)
Yeah.

Daphna Yasova Barbeau, MD (she/her) (01:25.312)
Mm-hmm.

Ben Courchia MD (01:28.21)
We have a lot of friends at Abbott and they're doing good work, but I think a lot of people were wondering like, well, if the FDA warning is for this one product, will we be able to then maybe revert to another? And a lot of people had mentioned the probiotic from Abbott. So now this has now entered the foray of this situation.

Daphna Yasova Barbeau, MD (she/her) (01:36.751)
Mm-hmm.

Ben Courchia MD (01:50.782)
So just if you want to check out the statement, you can go and take a look, but yeah, it's not over. It's continuing and I'm not exactly sure when this will come to a resolution. It's actually, you know what? I had a paper ready for today looking at outcomes after the introduction of probiotic supplementation in preterm infants, a study from Ireland, and I'm not in the mood to present it. I'm like, I'm so, I'm so down. I'm like, ugh.

Daphna Yasova Barbeau, MD (she/her) (02:03.869)
Yeah.

Daphna Yasova Barbeau, MD (she/her) (02:16.041)
Yeah, but the study showed some positive findings. That's right. More, more evidence, more evidence.

Ben Courchia MD (02:20.762)
100%. No, no, we know. I mean, that's what we discussed with on. There's, we, we actually, yeah, we recorded a special episode after the initial FDA warning that was issued with Dr. Ravi Patel and Dr. Rooney Toms on the show. So we've talked about this and we know that the data supporting probiotics is clearly there and there may be some regulatory issues in the U S that are compounding to a few cases, uh, with negative outcomes that are prompting these reviews and stuff, but.

Yeah, it's annoying when a tool that's been evidence-based and that shows benefits, you are not really allowed to use them. So yeah, whatever, we're gonna move on. It's okay.

Daphna Yasova Barbeau, MD (she/her) (03:00.799)
I think it's okay to be feeling frustrated.

Ben Courchia MD (03:03.226)
Yeah, yeah, yeah. Because NEC is such a terrible thing. It's like when we have something, exactly, once we have something that works. Who wants, do you want me to begin today?

Daphna Yasova Barbeau, MD (she/her) (03:06.507)
Yeah, and we have so few tools, right, Rick?

Daphna Yasova Barbeau, MD (she/her) (03:16.287)
Yeah, always.

Ben Courchia MD (03:18.102)
I have a few papers on PDA. I'm very excited about them. And yeah, but I'm going to start with a feeding paper because if I start talking about the PDA, it's going to be a long segment, and I don't want to hog the mic for too long in the beginning. I found this paper that, to be fair, may not be so new because the tool has been described before, but I really liked it, especially for us in the context.

Daphna Yasova Barbeau, MD (she/her) (03:21.165)
You are.

Ben Courchia MD (03:42.318)
of what we are trying to do in our unit. We're very much looking at our feeding protocol. This is something that we're discussing almost on a weekly basis. So we're in the weeds when it comes to, Daphna, to you and I, but it was interesting to see this paper. So it was published in the Journal of Perinatology, and it's called A Decade of...

evidence standardized feeding initiative targeting feeding milestones and predicting NICU stays in premature infants in all referral level for NICU First author is erica osborne. It's coming out of nation-wide children leaf neil and who spoke at the recent alphi conference is also on there um, so a very um A very serious group. Um, and so Uh what they're talking about they're giving some background information

in the background. And I think it's interesting that the diagnosis and management of the feeding process in preterm infants can be variable. But they mentioned that data from 2008 to 2016 shows that the average expenditure for an infant born at 24 weeks to gestational age was $603,778. And that this sort of represents the cost

Let me actually pull it up in the paper because the cost of the care for a 24-week infant with a standard deviation of basically half a million dollars. So it's huge. And the development of a successful oral feeding plan for each infant requires a lot of work, a lot of understanding, both of the pathophysiology, but also of the processes and the policies of your NICU.

and how that can change over time. So they at Nationwide developed in 2010, something that's called the Simple Feeding Program, Simple S-I-M-P-L-E, Simplified, Individualized, Milestone Targeted, Pragmatic, Longitudinal, and Educational Feeding Program.

Daphna Yasova Barbeau, MD (she/her) (05:49.105)
That might be on the list for one of the best mnemonics. Ha ha ha.

Ben Courchia MD (05:50.454)
That's on the list. Yeah, I know. That is on the list for sure. And it was developed to enhance the attainment of feeding milestones in their NICU. So the question that they're asking in this paper is the aims they are trying to achieve are to compare the difference in the cluster gestational age groups in attainment of feeding milestones, discharge feeding outcomes, and resource utilization. They're looking at.

see if they could develop models to predict the outcome based on feeding milestones and comorbidities. And number three, to assess maintenance and variation within the simple feeding program over a 10-year period based on acquisition of feeding milestones and outcomes. So the study design is basically that every baby that is born at 32 weeks of gestation or less that are less than 34 weeks, 34 weeks or less on admission and survive to discharge are screened.

They include babies with severe IVH, neonatal abstinence syndrome, chromosomal defect congenital birth defects, surgeries for PDA ligation, et cetera. Or if the baby had to be transferred before reaching full feeds, and if there was death prior to discharge. Then they looked at babies in terms of gestational age. They looked at perivariable kids, 24 weeks or less than 24 weeks. Extremely preterm, 24 to less than 28 weeks. And then very preterm, 28 weeks to 32 weeks.

Now the simple program, I'm not going to go into too much detail about that, but I think it's important to understand what they're talking about when they're saying that it is milestone driven. So basically it's a pragmatic feeding milestone criteria that they've described that goes as follows. And they have four milestones. Number one, start of trophic feeds by no later than day of life three. Milestone number two, progression of full enteral feeds defined as a hundred ml per kilo per day at no later than day of life 14.

milestone number three, first oral feeding prior to 34 weeks post-menstrual age, and milestone number four, full oral feeds defined as 120 ml per kilo per day by 38 weeks post-menstrual age. I really liked the program itself. I really liked the way they implemented this. Infants that are included in this simple program received focused multidisciplinary feeding rounds twice a week.

Ben Courchia MD (08:12.354)
that included the neonatologist, a nurse practitioner, the nurse of the patient, a nutritionist, a lactation consultant, occupational therapist, and parents. Now, interestingly enough, the targeted milestone that we just reviewed were displayed at the bedside as a reminder to the care team. And I think that's such a powerful message to have that sort of displayed for everyone to see that this is the goal that we set for ourselves.

In addition, didactic sessions were provided, addressing the progress of the program, accountability metrics, and education on varying topics such related to feeding and interesting case studies. Now, the goal of the simple feeding program was achievement of full oral feeds and decreased length of hospitalization stay. And the analysis of the data included demographics, feeding milestones, presence of comorbidity, such as IVH, BPD, discharge feeding outcome, and feeding outcome at six months and one year.

Any questions about that? No. OK. So between 2010 and 2020, all 605 infants with a gestational age of 32 weeks or less were screened. They excluded 171 infants. And so they remained 434 infants that met inclusion criteria. 24 subjects were periviable, less than 24 weeks. 197 were 24 to 28 weeks. And then

213 subjects were 28 weeks or more. Comorbidities, respiratory support at discharge, tube feeding at discharge, gastrostomy tube placement, and tube feeding at six months of age were all significantly higher with lower gestational age. So far, that's not really surprising. Feeding milestones, however, were attained significantly earlier at increased gestational age, and subjects were discharged at an earlier...

postmenstrual age with decreased length of stay. Again, something also that we were not so surprised to read about. Now the correlation with timing of reaching specific feeding milestones and postmenstrual age at discharge were significant for earlier initiation of enteral and oral feeding associated with earlier discharge. And so it's interesting to see that setting those milestones and reaching these milestones and the timing at which you reach these milestones

Ben Courchia MD (10:36.514)
tell you something about overall outcome. Regardless of gestational age at birth, oral feeding capabilities were maintained and improved beyond discharge when measured at six months and one year corrected age. And that's such a powerful aspect of these results that not only do you get to discharge your baby home early and in a good setup, but that there's momentum and that continues way past discharge.

I think that's super interesting. With this simple program, again, and I say simple, remember it's an acronym. I'm not talking about this as a simple program. With the simple program, a lower length of stay and post-menstrual age at discharge were maintained over the years. And they have a lot of different graphs showing that. The conclusions of the paper are that this simple feeding program minimized variability, which is a huge issue, promoted acquisition of feeding milestone consistently.

and that length of stay is predictable using feeding milestones, comorbidities, gestational age and post menstrual age at feeding milestones. Now, they developed, I forgot to mention this last part of the conclusion, but they did develop trying to do a linear regression. And so there's like a little model as to could you predict when the baby is going to go home depending on when they reach those milestones. But I must say that while they did do that, I don't think.

going to go on the limb here. I don't think it was available. It's not like it's released for use. So yeah, but that's the first paper, a very interesting study.

Daphna Yasova Barbeau, MD (she/her) (12:12.351)
Yeah, I mean, I think it's a problem like a lot of units are struggling with, you know, like we have the data on feeding. So how do we, you know, really use that to drive our feeding protocols in the unit? But I mean, I think this just underscores that multidisciplinary approach that everybody knows what the expectations are. And

You know, it includes the bedside nurses, it includes the families. So people are saying like, oh, when's the next step? Aren't we supposed to be on the next step? Um, and those, that education, you know, about why it's important.

Ben Courchia MD (12:48.887)
Yeah. OK.

Daphna Yasova Barbeau, MD (she/her) (12:50.975)
All right. I liked it. And I liked that acronym very much. Yeah. It didn't sound like the program was so simple. It's still quite time intensive, but yeah, it's this simple program. It's not simple, but it looks like it is. It is worth the effort. Okay. I had this paper, um, entitled a short course antibiotic therapy for pneumonia in the neonatal intensive care unit.

Ben Courchia MD (12:54.602)
Mm-hmm.

Ben Courchia MD (12:59.018)
That's right. I know, but I realized as I was saying it, I'm like, this simple, this simple program. It's like, but it's not simple.

Daphna Yasova Barbeau, MD (she/her) (13:20.863)
Lead author Zachary Leewald. This is coming from the Nationwide Children's Hospital Neonatal Antimicrobial Stewardship Program, or NEOASP. This is in the Journal of Perinatology. They wanted to determine the adherence and safety outcomes of a five-day antibiotic course with a timeout for treatment of blood culture negative pneumonia in the NICU. So you diagnose

There is no associated positive blood culture. Can you treat with five days of antibiotics instead of a longer course? So this was a prospective surveillance study. It looked at all infants who received antibiotic therapy for pneumonia at the seven nationwide children's hospitals, NICUs from August, 2020 to December, 2021.

So basically what they did is anytime you placed an antibiotic order for, quote unquote, pneumonia in the electronic health record, it was set with like an automatic stop at five days, where at the fifth day, it would time out and the team had to decide, were they happy with the five-day course or were they going to reassess and continue the therapy beyond five days?

And then the order had to be updated or a new order was created with a new stop date that was determined by the treatment team. In addition, they say the study pharmacists as well as a neonatologist and a pediatric infectious disease specialist conducted these neo-antibiotic stewardship rounds every Monday and Thursday and recorded the information on all infants who received antibiotic therapy for pneumonia.

and then they discuss their recommendation with the treatment team. I think it's important to note what they use to diagnose pneumonia. And it's a long one. So they diagnosed pneumonia based on clinical and radiographic abnormalities, not always positive cultures. I think that's important to note.

Daphna Yasova Barbeau, MD (she/her) (15:36.919)
So these clinical findings included escalation of respiratory support, lack of improvement after surfactant, increased tracheal secretions, apnea, bradycardia, frequent desaturation episodes, temperature instability, abnormal white blood cell count, elevated CRPs, or an abnormal chest x-ray. Bacterial culture of endotracheal aspirates among ventilated infants was not routinely recommended, performed or required for this diagnosis of pneumonia.

And as I said before, infants with positive bacterial cultures of the blood, the urine or the CSF were excluded. They were also excluded if they were tested positive for respiratory virus. And in general, so they both looked at early onset and late onset. So in general, empiric antibiotic therapy for possible early onset sepsis, less than 72 hours was AMP and GENT. And for empirical therapy for possible late onset sepsis, greater than 72 hours, infants

gent and either naphthalene or vancomycin depending on their history of MRSA. Okay, I think that gives us enough information for me to move on to the baseline characteristics. So during this 20-month study period, 128 infants were diagnosed with 136 episodes of

Daphna Yasova Barbeau, MD (she/her) (17:05.307)
and the range was one to 19 days. The infants had a median chronological age of two, sorry, I'm sorry. The infants had a median chronological age of two days and the majority, 88% of episodes were treated with five days total of definitive antibiotic therapy. So they had pretty good adherence to the policy of only using five days.

But the median length of treatment and definitive antibiotic therapy were six days. And so sorry, I'm sorry, the median interquartile length of treatment were six days and the definitive antibiotic therapy was five days. So bacterial culture of the endotracheal tube aspirate was performed in cases, all of which were late onset.

And the majority of those were gram-negative organisms. The most common organism was Pseudomonas, and the second most common organism was Staph aureus. There was no difference in the median birth weight and gestational age of infants who received less than or equal to five days versus greater than five days of antibiotics for this early onset pneumonia. But of note, this was a pretty mature group. So the group median

birth weights were 3250 grams versus 2785 grams. The safety outcomes were defined as antibiotic restart within 14 days of discontinuation of this definitive antibiotic treatment, as well as looking at mortality. Of the 136 episodes of pneumonia, 22 episodes, or 16 percent, were identified as positive

had antibiotics restarted within 14 days. In those who were treated for early onset pneumonia, antibiotic therapy was restarted in 4% or three out of 75 cases, and all three were among infants who received five days of therapy. And none were restarted among the seven episodes treated with seven or eight days of antibiotics.

Daphna Yasova Barbeau, MD (she/her) (19:23.243)
Among the late onset episodes, 19 or 31%, there was restarting of the antibiotics within 14 days, but the majority, with the majority, so 16 of the, hold on, 16 of the 19 were restarted in those after five days of definitive antibiotic therapy. However, pneumonia was the reason for antibiotic restart in only three of the 22 cases.

with NEC being the most common reason for restarting antibiotics after that treatment for pneumonia in the late period.

Ben Courchia MD (20:04.283)
And this is where you feel like, shoot, I missed it. It was NEC, maybe it wasn't.

Daphna Yasova Barbeau, MD (she/her) (20:10.223)
Maybe the initial presentation wasn't pneumonia is what you're saying. Is that what you're saying? Yes. Okay. And then they wanted to look at overall mortality. The overall mortality was 5%, 7 out of the 128, with 5 of the 7 deaths assessed as sepsis related. So 3 of these deaths occurred within 14 days of antibiotic discontinuation.

Ben Courchia MD (20:19.275)
Yes, sorry, yeah.

Daphna Yasova Barbeau, MD (she/her) (20:36.451)
all were due to blood culture proven sepsis due to gent susceptible pseudomonas. So these were patients who were treated for pneumonia that was blood culture negative and then they had restarted of antibiotics where they had sepsis with pseudomonas. Okay. I also wanted to tell you, they then further describe a...

these three deaths that occurred within 14 days. One of the infants had received seven days of antibiotic therapy for the previous pneumonia when then the endotracheal aspirate grew pseudomonas again. Another patient, the previous diagnosis of pneumonia was then followed by an endotracheal aspirate that grew staph epi.

And then the last patient they wanted to describe, again, had a previous pneumonia, but they did not have a culture performed of the endotracheal aspirin. And overall, there was no significant difference in the combined safety outcome of antibiotic restart or mortality between the less than or equal to five and the six to 20 days of definitive antibiotic therapy. So,

Their overall conclusions were that for most babies, five days is an inappropriate therapy. And I still think they had some concerning babies that may have warranted more antibiotics.

Ben Courchia MD (22:18.722)
I was gonna ask you.

Ben Courchia MD (22:22.818)
So transparency dictates that we don't have an overbearing ID team in our unit. So you want to order seven days, you get seven days. Uh-huh. There's no, I used to work in institutions where the bank had to be approved and where it would fall off and you would have to request, so that's, that's different. But

Daphna Yasova Barbeau, MD (she/her) (22:29.859)
That's right. You do whatever you want.

Daphna Yasova Barbeau, MD (she/her) (22:40.007)
Or we've also worked at institutions where the opposite, where the, actually the ID team very liberal with the antibiotics.

Ben Courchia MD (22:44.279)
very liberal.

Yeah. But I was reading this paper as well, and I'm looking at it, and it's hard. It's hard to just tweet for five days. I'm not exactly sure what that is, that you're like, it feels like it's not enough. I don't know how to say this. I know this is not scientifically based. And then the question becomes based on the concerning babies that you've mentioned. Well, what if I did the seven days, right? That's the question. All right, so.

Daphna Yasova Barbeau, MD (she/her) (23:03.791)
That's right.

Ben Courchia MD (23:18.682)
It's hard to gauge the benefits of both approaches when it's kind of nebulous in terms of the outcomes that we're looking at. So I don't know. But the other thing, in my opinion, that is very problematic with these types of paper is that we don't really have a good unified definition of pneumonia or ventilator-associated pneumonia. So if you could clearly know what we're talking about, but it's sort of like, I mean, it's always the same. It's like, I think this is ventilator-associated pneumonia, right? It's...

Daphna Yasova Barbeau, MD (she/her) (23:35.555)
That's right.

Daphna Yasova Barbeau, MD (she/her) (23:45.099)
Yeah, I mean, that's the point. The clinical findings in pneumonia are the same clinical findings often in sepsis, and they can be the initial presentation of NEC before even abdominal distension, unfortunately. And this concern about are endotracheal cultures helpful, accurate is an ongoing debate in the community.

Ben Courchia MD (23:53.278)
of sepsis exactly.

Ben Courchia MD (24:11.231)
Yeah.

Daphna Yasova Barbeau, MD (she/her) (24:14.783)
I think what it says is for this healthy-ish babies that five days is probably enough. I think one thing I will take away is if I think it's pseudomonas, then maybe I will not treat for the five days.

Ben Courchia MD (24:22.783)
Mm-hmm.

Ben Courchia MD (24:29.806)
Okay, that's fair. Yeah, because when you look at the definition, I mean, the definition, I forget where I got that definition from. The source is escaping me right now. But the idea of ventilator-associated pneumonia usually revolves around the fact of like, you must have some change on your CBC, like some leukocytosis or some bandemia. There must be a change on your respiratory support. There must be associated findings on the chest X-ray.

Daphna Yasova Barbeau, MD (she/her) (24:52.611)
Mm-hmm.

Ben Courchia MD (24:57.686)
But like you said, all these things could happen in so many other, they're not exclusive of pneumonia. They could happen in a variety of other syndromes. So it makes it tough.

Daphna Yasova Barbeau, MD (she/her) (25:06.559)
it was also interesting that they talked about this early onset, so really congenital pneumonia, right? And that's kind of a nebulous pathology, right, that we have, right? It's a brand new baby we don't know anything about, and they need a lot of respiratory support, right, which may be based on their age or their clinical picture or infection. So it's an interesting group.

Ben Courchia MD (25:15.475)
Mm-hmm.

Ben Courchia MD (25:19.873)
as well.

Ben Courchia MD (25:29.235)
Yeah.

Ben Courchia MD (25:34.176)
Yeah.

Daphna Yasova Barbeau, MD (she/her) (25:35.295)
Okay, what else you got? Are you gonna talk about the PDA now?

Ben Courchia MD (25:38.34)
Let's do the PDA. I have three papers on the PDA.

Daphna Yasova Barbeau, MD (she/her) (25:43.785)
is right.

Ben Courchia MD (25:44.002)
But you know, I started reading one. I'm gonna go, one is gonna go rather quickly because I wanna really get into the data more than the actual wording itself. The first one I'm gonna start talking about is the one published in Pediatrics. It's called Pericutaneous Closure of the Patent Doctor's Arteriosis in Infants Less Than Two Kilos, the Impact Registry Insights. First author is Adrian Reidy Bischoff. Last author is Pat McNamara. Yeah, so.

There's a discussion about when to treat. How do we treat is there's a big shift happening in our field that's been going on for some time now. But percutaneous techniques have, first of all, overtaken surgery as the primary mode of ductal closure. And there's emerging evidence that non-intervention or delayed intervention may be associated with worse neonatal outcome, like bronchopulmonary dysplasia.

And so how do these new percutaneous techniques help us in dealing with the PDA are being investigated very thoroughly? There's some data that suggests that conservative treatment may not be harmful either. So the question will have to be asked as to, we'll need to continue to be asked as to what should we be doing. Now,

Ben Courchia MD (27:12.098)
The safety of percutaneous PDA closure, there's been some data that has been published already on that topic. But the different papers that have been published may be at the risk, according to the authors of this study, to potential publication and selection bias. And they're mentioning an LFK index of minus 4.56.

I did not know what an LFK index was. So I looked it up and this is going to be our little biostat moment, the biostat minutes of the incubator podcast. But the LFK index is used to evaluate bias and meta-analyses. And the closer the value of the LFK index is to zero, the more, the more, the less there is bias and the more symmetrical the DOI plot is.

Now the values that fall outside of minus one and plus one are consistent with what's called asymmetry or publication bias. So minus 4.5 seems concerning. So the IMPACT registry, which stands for the Improving Pediatric and Adult Congenital Treatments from the American College of Cardiology Foundation.

So this is the registry that's being used. And the objective of the study was to assess the safety and feasibility of percutaneous PDA closure in a large registry of patients who were less than two kilos at the time of the procedure. Why do I think this is an important point is because we've worked in multiple institutions. And depending on the size of the institution, this is becoming the prevalent method of doing things and we'll talk more about that.

Ben Courchia MD (28:56.974)
treatment, you may be unaware of this shift as it is happening. So they collected this data from the impact registry, as it's been previously described. They included babies who were two kilograms or less at the time of percutaneous PDA closure in a cohort that spanned 2016 to 2021. They excluded babies who had a history of cardiac catheterization or cardiac surgery.

that had diagnosis of congenital heart defect, obviously with the exclusion of a PFO or an AST, and infants undergoing additional procedures besides PDA closure. Now, they characterized the PDA based on echo, and they were using the angiographic type was based on the Krechenko classification with minimum diameter, diameter at the aortic side and length.

and all that stuff was documented. The ductile length, if it was less than four millimeter, it was considered quote unquote a short PDA, and device specifications were recorded when available. They also recorded the type of access, whether it was done via a venous or an arterial or both. They looked at fluoroscopy time, dose. They looked at the duration of the procedure. They looked at hemodynamic data, including systolic pulmonary artery pressure, ratio of pulmonary to systemic blood flow, and indexed pulmonary vascular resistance. All that stuff was documented.

The primary outcome of the study is the composite of technical failure and or MAE, which in the paper MAE stands for major adverse events. The major adverse events were defined according to previous publication. They included cardiac arrest, cardiac tamponade requiring drainage, airway event that required escalation of care, device malposition or thrombus requiring surgery, device embolization requiring retrieval, unplanned surgery.

or catheterization and so on. There's a long list of them. Unplanned surgery and the need for subsequent cardiac cath was considered until the time of hospital discharge. Because of the inability to attribute all adverse events to the cardiac catheterization, major adverse events were chosen if they could be definitively linked to the procedure, like device symbolization, for example, or highly likely to be attributed to the procedure, like Temponon.

Ben Courchia MD (31:22.475)
Interestingly, death was not included as a major adverse event because, in this version of the impact registry, it cannot be directly linked to cardiac catheterization given the multiple competing, confounding illnesses in extremely preterm infants. Meaning, they're so sick at baseline that it's hard to pinpoint exactly and say that it is because of that they died. However…

Daphna Yasova Barbeau, MD (she/her) (31:44.427)
I guess.

Ben Courchia MD (31:48.618)
They did record deaths in the first 24 hours, likely attributable to the procedures in the first seven days and the 30 days after. So I'm like, I don't know. Maybe you can pinpoint to the procedure. So I think that's interesting. Let's go over some of the results. The Impact Registry recorded an attempted 1,594 percutaneous PDA closures in patients that are less than two kilos between April 2016 and...

June 2021. The final cohort for analysis included data from 87 hospitals and with a few exclusion 1,587 infants that were under two kilos undergoing percutaneous PDA closure. Now, figure one shows the volume of cases performed for each quarter. Daphna, I'm gonna share my screen for one second because that is interesting. Maybe you do have the...

the paper in front of you already, but look at the volume per quarter going through the study. You see an upward trajectory of the number of cases over time. Going back to what... Yeah, exactly. So there's a huge momentum being carried with this procedure. Among the 1,587 attempted PDA closure, 97.6% had a device successfully implanted.

Daphna Yasova Barbeau, MD (she/her) (32:53.539)
Yeah.

Yeah, I mean, it's like totally linear.

Daphna Yasova Barbeau, MD (she/her) (33:02.127)
increase. Yeah.

Ben Courchia MD (33:12.99)
major adverse event occurred in 3.8% and the composite outcome occurred in 5.3% of the patients. So the primary outcome was technical failure and or major adverse event. So I think it's interesting, number one, as we're being asked to counsel these families, this data is something we're gonna have to learn, right? So how successful is PDA closure percutaneously? Above 97%.

The number of major adverse events, about 4%. Death and major adverse event, about 5%. I mean, these are numbers that you probably would jot down. The median gestational age at birth was 25 weeks, and approximately 37% of the infants were born before 25 weeks. The median age and the weight at the intervention were 37 days and 1.2 kilos respectively. There were 16 patients who were less than 700 grams.

when they went for percutaneous PDA closure, which is a huge game changer for the fact that you can actually send these kids for catheterization when they are this small. Weight used to be an exclusion factor for when we could intervene on these PDA surgically. And now you're looking at these kids that are 700 grams, 600 grams and are interventional cardiologists are able to do it. So that's quite amazing. The incidence of major non-respiratory comorbidities at the time of catheterization was 8% with necrotizing enterocolitis.

and 19, sorry, was 8%, 5.8% was NEC and 2.1% was sepsis. Okay, so table one compares the demographic and procedural characteristic of the infants experiencing the composite outcome of technical failure or major adverse event. And they're looking at various things depending on whether they had the technical failure or major adverse event. I wanted you to look at this. Number one, if access is obtained via a venous route, there's...

versus arterial, it's quite interesting to see the difference. So in the cases where there was technical failure and or major event, 88% of these cases were accessed through venous access and 12% arterial. But when there wasn't, it was when 97% in the cohort where there was no major adverse event or device failure,

Ben Courchia MD (35:36.362)
It was 97% venus and only 2.5% arterial. So it seems like going the venus route may be the way to go. Not that I'm doing this any day soon, but it's interesting to see that.

Daphna Yasova Barbeau, MD (she/her) (35:46.64)
You can let your proceduralist know what you'd like them to do.

Ben Courchia MD (35:50.454)
That's right. Interestingly enough, the duration of the procedure mattered. There was less primary outcome if the procedure was shorter. Again, I'm not sure if this is like chicken or the egg. Was the procedure? Yeah. Now, there's a figure two which depicts the distribution of the composite outcome according to weight and age. So there's a graph for weight and a graph for age at the time of the procedure. And they're looking at this biphasic aspect of the curve.

Daphna Yasova Barbeau, MD (she/her) (36:01.039)
Chicken or the egg? Yeah. Right.

Ben Courchia MD (36:19.138)
when assessing age at the time of the procedure with an initial decrease in the incidence of the composite outcome between the first postnatal week and approximately 30 days. And then there's a secondary mild increase around 40 to 50 days. I have to say it's diff, I mean, it is, it looks biphasic to be honest with you, but yeah. So it seems like this is gonna be some.

Daphna Yasova Barbeau, MD (she/her) (36:41.903)
I mean, I think this table is cool. I mean, this graph is cool. You know, we say like, is there a right time? Is there a right weight? Maybe, yeah, it kind of looks like there could be.

Ben Courchia MD (36:48.866)
That's right.

Ben Courchia MD (36:53.302)
Right, I know, yeah, the right weight, maybe like around like a kilo seems to be good. And the age seems to be like between two weeks to a month of age seems to be maybe an opportune time. So that's interesting. Some of the procedural characteristics and then I guess I have more things, sorry, I'm not done. The median minimal PDA diameter, the diameter on the aortic side, and the length were 2.6, 3.9, and 9.8 millimeter respectively.

Daphna Yasova Barbeau, MD (she/her) (36:55.467)
Right, this one kilo, yeah.

Daphna Yasova Barbeau, MD (she/her) (37:02.985)
Mm-hmm.

Ben Courchia MD (37:24.35)
What devices were used? And that's an important point because we're going to talk more about that. Among the 1,549 infants with successful device closure, 44% used the M-Platser Piccolo occluder. I'm pronouncing the M-Platser probably wrong. 24% had the microvascular plug. 16% used the M-Platser Ductal Occluder II. And 4.3% used the M-Platser Vascular Plug.

2, and 10% used other devices. In terms of procedural success and failure, procedural failures represented 2.3%. So that was 38 cases. 16 of them, the device was implanted but not released, or implanted, released, retrieved, and not subsequently placed. The rates of procedural failure were similar across weight, which is very interesting. You would think, oh, the smaller the baby, the worse it's going to be.

Not true. Less than 1,000 grams, 1.6%. One to 1.5 kilos, 2.7%. And 500 grams to 2,002.4%. Now when you're looking at this based on age, if there were less than 30 days, the rates of procedural failure was 1.6%. Beyond 30 days, 2.7%. Not statistically significant, but interesting to see nonetheless.

Daphna Yasova Barbeau, MD (she/her) (38:46.295)
Mm-hmm.

Ben Courchia MD (38:49.186)
Technical failure was more common in patients with some arterial access, as we mentioned earlier, versus those with only venous access, 8.3 versus 2.1%. This was statistically significant. Procedural duration was longer in patients with technical failure. We just, we spoke about that as well. Talking about the composite outcome, this is where it gets interesting. Composite outcome of major adverse events or technical failure occurred in 5.3% of the total cohort and 12% of the cohort.

Daphna Yasova Barbeau, MD (she/her) (39:03.453)
Mm-hmm.

Ben Courchia MD (39:18.818)
that's less than 700 grams, which again, it's a bit higher, but 12%, 700 grams or less, I mean, this is nuts. But listen to this, hospitals with an annual volume of cases above the median had a lower incidence of the composite outcome. So we're seeing something that's not surprising, but that hospitals who do this more frequently will have better outcomes. Finally, let's talk a little bit about major adverse event and then we'll get into the conclusions.

Daphna Yasova Barbeau, MD (she/her) (39:19.849)
Mm-hmm.

Daphna Yasova Barbeau, MD (she/her) (39:26.485)
Mm-hmm.

Daphna Yasova Barbeau, MD (she/her) (39:35.273)
Right.

Mm-hmm.

Ben Courchia MD (39:46.73)
Covariates associated with the likelihood of developing a major adverse event are showed in table three in the paper. They obviously talked about the annual volume of cases as being an important component. The most common major adverse event was device embolization requiring retrieval. That sounds terrifying. Other major adverse event included cardiac arrest, 0.7%, cardiac tamponade, 0.3%, device mild position, 0.6%.

unplanned cardiovascular surgery, that's 1.3%, need for subsequent catheterization within 72 hours, that's 0.6%, arrhythmia requiring treatment, that's 0.6%, major bleeding, that's 0.6%, airway escalation of care, 0.5%. So, aside from the device embolization that requires retrieval, which is 1.3%, each individual one is always like less than a percent almost, so that's interesting. And the rate of major adverse events in patients that are less than 700 grams,

was 12.5% versus 3.7% looking at kids who were beyond 700 grams. One of the institutions we worked at only did it on 700 grams or more. Maybe there's a reason for that. There's a nice graph as well looking at the composite outcome based on the weight and the time and you can see that also over time as centers start to do this, the rates of composite outcome in percentage failure and adverse events.

sort of decreases over time. That's interesting.

Daphna Yasova Barbeau, MD (she/her) (41:14.239)
But like, by 50%, it's a lot.

Ben Courchia MD (41:17.522)
Mm-hmm. The conclusion of the paper is that the percutaneous PDA closure appears to be safe, feasible procedure in infants that are under two kilos. And although the evidence for infants that are less than 700 grams remains limited and requires careful monitoring, the incidence of major adverse event has continued to decline and is strongly influenced by individual center case volumes and expertise.

the establishment of regional high volume centers of excellence for procedural intervention may help mitigate risk for technical failure and major adverse events. This is where the business side of medicine is gonna get kind of tricky. There might be an arms race when it comes to that. So if you are a resident, and interventional cardiology is something you're interested in, there might be a, it might be in high demand in the coming years.

Additionally, collaboration between neonatologists, hemodynamic specialists, interventional cardiologists is imperative to ensure ongoing quality of study, assessing clinical relevant outcome. This is definitely a statement courtesy of the University of Iowa, but they're not wrong. So that's paper number one.

Daphna Yasova Barbeau, MD (she/her) (42:21.583)
That's the short paper.

Ben Courchia MD (42:23.742)
No. That was a long paper, thankfully.

Daphna Yasova Barbeau, MD (she/her) (42:24.975)
Good. Oh, good. Okay. No, but I think it's interesting, especially with the little, little babies, right? Especially as, I mean, in general, the community is moving against treating PDAs, right? That's the sense in the community. And if there's maybe a sweet spot where you have, hold on, you're going to, I'm getting too ahead of myself.

Ben Courchia MD (42:32.726)
Mm-hmm.

Ben Courchia MD (42:48.566)
Hold on, I'm gonna stop you right there. So let's talk. No, you're not gonna get enough of yourself, but it's interesting because I had the same thoughts, but then there's some papers that are gonna reinforce what you're saying. And so let's, so in the Journal of Perinatology, there's a paper that is called A Three-Year Follow-Up of a Prospective Multi-Center Study of the M. Platzer Piccolo Occluder for Transcatheter Patent Ductus Arteriosus Closer in Children Who Are Above 700 Grams. First author is Brian Moray.

Daphna Yasova Barbeau, MD (she/her) (42:57.695)
Okay, all right, you go.

Ben Courchia MD (43:16.518)
And this is a paper that actually Gabriel Alted reviewed on the French podcast. So I, um, I did get a first pass thanks to him, but it's interesting that we have now a paper also that's coming out with three year outcomes with the use of this particular device and the, um, and Platzer Piccolo occluder, which again, I'm not familiar with the whole, I'm very, I like gadgets, but I'm not familiar with all the different occluders. I'm sure, I'm sure cardiologists are geeking out over this, but I don't.

So it was previously called the M. platypiductal occlusure two additional sizes, the ADO2S, A.S. And it received CE mark for PDA closure in infants that were above six kilos in 2011. A pre-marker trial of the M. platypiductal occluder was conducted in the United States and enrolled 200 children for transcatheter device closure of the PDA. And then the six months results demonstrated a high procedural success rate above 95%.

and their low rate of major complications, kind of what we were discussing just now. Based on these data, the Implacer Piccolo occluder received approval for commercial use in the US by the FDA in 2019 for inpatients that are above 700 grams. Now this study that we're looking at right now, which is published in the Journal of Perinatology, reports the three-year clinical outcomes from this cohort of infants. So...

This was a single arm prospective multi-center pre-market clinical investigation designed to characterize the safety and effectiveness of this Implatser Piccolo occluder manufactured by Abbott in children above 700 grams and more than three days of age at the time of implant. The study included two cohorts. So there was an investigational device exemption cohort, the IDE cohort, which was 50 patients enrolled between 2017 and 2018.

a continuous access protocol, a CAP cohort, with 150 patients enrolled between 2018 and 2019 at nine sites. To be included, you had to have a PDA that was less than four millimeters in diameter and more than three millimeter in length based on intra-procedural echocardiogram or angiogram. They had some exclusion criteria, which I will skip. The patient follow-up occurred prior to hospital discharge and at 30 days and six months post-procedure.

Ben Courchia MD (45:37.494)
There was additional follow-up visit that took place at one, two, and three years post-implant. All patients from both cohort, from the IDE and the CAP cohort, were assessed at each follow-up for adverse events. Now the IDE cohort was required to undergo transthoracic echo at each follow-up. The study protocol did not require the CAP cohort to undergo TTE beyond six months post-procedure

a residual shunt that was observed at six months. So PDA closure was defined as the presence of either no grades, so grade zero, or a trivial residual shunt, grade one, as assessed by an independent echocardiography core lab. Major complication was defined as device or procedure related adverse event resulting in death, life threatening adverse event, persistent significant disability, incapacity, and or major open surgical intervention. So.

Let's get into some of the results. 200 patients are enrolled between the IDE and the CAHPS study periods. The entire study cohort was evenly split between procedural weights. There were either less than 2 kilos. That was 100 patients. And more than 2 kilos, that's another 100 patients. A total of 132 infants were referred for PDA closure from the NICU. The average birth weight was 850 grams plus minus 390. And an average gestational age of 26.

plus minus three weeks. Of the NICU infants, 91% were on mechanical respiratory support, 7% were on inotropic support at the time of PDA closure, which I think is reassuring to see that they look like hemodynamically significant issues. Comorbidities of prematurity in the infants from the NICU included 78% of respiratory distress syndrome, 41% with IVH, 21% history of sepsis, 14% history of NEC. Very interesting.

point, prior treatment with Cox inhibitor was performed in 37% of the infants from the NICU. Medical management prior to the piccolo implant was at the discretion of the institution and of the nine study sites, seven had low usage of Cox inhibitor prior to the procedure. So that's very interesting. Does that mean that like you were hinting at, if we have a procedure that works super well, that's very minimal, are we going to start just shifting

Daphna Yasova Barbeau, MD (she/her) (47:51.839)
Mm-hmm.

Daphna Yasova Barbeau, MD (she/her) (47:55.119)
Mm-hmm.

Ben Courchia MD (48:02.282)
Send that kid to the cath lab and get it closed. The acute, ah, hold on. The acute procedural implant success rate was 95.5%. 92% in patients that were above two kilo and 99% in patients that were less than two kilo. So the smaller babies had better procedural implant success rate. What happened at six months and three years? Because that's what we're interested in.

Daphna Yasova Barbeau, MD (she/her) (48:05.507)
I guess... Okay...

Ben Courchia MD (48:31.102)
At six months of the 191 infants who underwent successful implant, 186 were still enrolled in the study at six months. A total of 180 patients completed the six months follow-up visit with an echo. Seven could not be read, so only 173 were left. And the effective closure of the PDA by echo criteria was achieved in 99.4% of patients available echo at six months, what about three years? 186 patients were eligible.

There were some exclusions, so 182 were eligible for the follow-up at three years. Survival at three years was 95.3% for babies above two kilos, 92.9% in babies that are less than two kilos. Beyond six months, there were no additional device or procedural-related complications. Impressive.

Of the nine patients who died following device implants, seven were less than two kilos at the time of the implant and the causes of death included respiratory failure in six of them, bleeding following an unrelated abdominal surgery in one of them, necrotizing enterocolitis in one of them, and cerebral infarction in one more patient. The median time from device implant to death was about 141 days. After an independent review by the CEC, no deaths were adjudicated as device or procedure related.

Of the 50 patients enrolled in the IDE cohort who were required to have imaging at each visit, 33 had an echocardiogram available for review at the final three-year follow-up. The findings demonstrated effective PDA closure in all patients. ECHO follow-up demonstrated that effective PDA closure was achieved in 97.4% of patients 30 days post-implant, which then increased to 99.4% at six months and was subsequently sustained at 100%.

three years of follow-up for the IDE cohort. There were no cases in which the PDA reopened following documented closure. So very impressive stuff. The figure is quite impressive. In terms of major adverse event, major device or procedural related complications through six months occurred in four patients, two transfusion, one hemolysis, one aortic obstruction. Post procedure aortic obstruction required intervention with a stand placement, and apparently that was

Ben Courchia MD (50:52.386)
that solved it, and there was another one with an increase in tricuspid regurgitation in five patients. So the conclusion of this particular paper are that transcatheter closure of the PDA in pediatric patients with this M. platzor piccolo occluder safe and effective with more than 99% procedural success in patients that are less than two kilos, 100% closure documented out to three years in the IDE cohort of the study.

and overall cohort survival of more than 95% at three years. Major procedure or device related complications are uncommon. These data are important stepping stones to improving procedural technique and safety establishing benefit of trans- blah, blah. You get what I'm, you get the end of the story. So very interesting data. And then the final thing I wanna mention about PDA and give a shout out to our friend on Twitter as well, it's a paper that was published in the Journal of Pediatrics and it is called

Daphna Yasova Barbeau, MD (she/her) (51:34.54)
Hehehe

Ben Courchia MD (51:48.578)
Trends in procedural closure of the paid inductors arteriosus among infants born at 20 to 30 weeks gestation. First author is our friend Zubin Shah. Zubin, how's it going, my friend? This was data that was using the Pediatrics Clinical Data Warehouse to try to look at recent trends in procedural closure of the PDA among premature infants and compare the clinical characteristics of infants receiving surgical versus transcatheter closure. They looked at infants that were born between 22 and 29 weeks from 2014 to 2021.

Primary outcome was the report of a diagnosis of PDA and other morbidities. And they were looking at ligation or transcatheter occlusion. Yeah. Exposure to medications and so on. They had 64,000 infants in the cohort of whom 24,000 were diagnosed with a PDA. So 37%. The number of infants receiving any procedural closure of the PDA decreased from 4.4% in 2014 to 1.9%.

in 2021. However, what's interesting about that is that during the same period, the number of surgical location decreased as well, 4.4% to 0.8%. But the number of transcatheter occlusion increased from 0.02% to 1.05%. That was significant. They have a beautiful graph that I think Zubin posted on Twitter, where you can see how overall we're surgically not really closing these PDAs anymore, but

when we are, the proportion of them being closed through transcatheter occlusion is getting larger and larger and larger. The median age at surgical ligation increased from 25 days to 31 days, and the median age of transcatheter occlusion decreased from 103 days to 43 days. So we feel much more comfortable closing these with the transcatheter earlier. Looking at the pharmacological treatment of PDA,

Daphna Yasova Barbeau, MD (she/her) (53:19.372)
Mm-hmm.

Daphna Yasova Barbeau, MD (she/her) (53:35.253)
Mm-hmm.

Ben Courchia MD (53:44.19)
It's also very interesting because we said in that other study that only like maybe a third received pharmacologic treatment. But in that case, looking at any pharmacologic treatment, which includes acetaminophen, ibuprofen, endomethacin, we saw that the rates of pharmacologic treatment went down from 21 percent in 2014 to 16 percent. And it's quite it's almost linear. It's not really linear because it would not be the PDA dilemma.

Daphna Yasova Barbeau, MD (she/her) (53:49.042)
Mm-hmm.

Daphna Yasova Barbeau, MD (she/her) (54:06.059)
Mm-hmm.

Ben Courchia MD (54:09.61)
It went from 21 to 18 to 14 to 12, and then back, and no, sorry, it was linear, I'm so sorry. I'm gonna take that back. So the use of pharmacologic treatment went down across the years from 2014, it went from 21 to 18 to 14, and then to 12%. So the summary of that paper is that there's a decrease in surgical closure, an increase in transcatheter occlusion of the PDA, and that prospective trials such as

Daphna Yasova Barbeau, MD (she/her) (54:09.752)
Hehehe

Ben Courchia MD (54:34.882)
what's ongoing right now with the pivotal trial are needed to determine how these practices changes affect the clinical outcomes of premature neonates. And these are the PDA papers I read.

Daphna Yasova Barbeau, MD (she/her) (54:45.711)
You know, I liked this bunch, I will say, because I think it certainly adds to the discussion, because really the discussion has been about medical closure, I feel like, is in bulk. And so I think it's an interesting component. You know, in the studies of PDA closure or not, was it the PDA? Was it the medication? I mean, maybe this is hinting towards it's maybe some of the medications that we're using.

Ben Courchia MD (54:57.427)
Yeah.

Daphna Yasova Barbeau, MD (she/her) (55:14.435)
versus having the opportunity to do it with this trans catheter closure. Though, I mean, we should mention that they're not without risk, right? Some babies have to be transported for this procedure to a different facility. So, you know, those are major processes.

Ben Courchia MD (55:34.57)
Yeah, but what's interesting is that it's changing the paradigm where we were wasting a lot of time with medical treatment because we're like, man, am I going to send this kid for open chest ligation of the PDA? But now the alternative is like, hey, now I can actually, and then there was always this thing of the surgeon telling you a kid's too small, I can't, we're like, we need to grow this baby a little bit more. But now it's like, hey, I really don't.

Daphna Yasova Barbeau, MD (she/her) (55:45.28)
Mm-hmm.

Daphna Yasova Barbeau, MD (she/her) (55:56.354)
Right.

So you said in the interim, should I? Yeah, I feel like I need to close it. Should I close it? Yeah.

Ben Courchia MD (56:02.806)
Yeah, but now it's like I could potentially send this kid to a cath lab at a very small weight. The success rates are quite high. How long then do you say that we're going to tolerate some hemodynamic instability? Right? I mean, that's where it gets super interesting. And that's why I was saying how the business of medicine hopefully doesn't make this too dirty because like, yeah, I mean, it's nice for hospitals to bill for a...

CathLab for neonates is probably making, I mean, I don't know. I'm not in the administration. I'm assuming it makes money. It makes definitely more money than giving ibuprofen, I'm sure. Uh, so, um, is that going to influence things as well? I don't know. We have to be careful about that because yeah, we can't let this sway the, hopefully not.

Daphna Yasova Barbeau, MD (she/her) (56:36.655)
for sure.

Daphna Yasova Barbeau, MD (she/her) (56:40.623)
Hmm, interesting.

Daphna Yasova Barbeau, MD (she/her) (56:49.847)
I mean, I think, I hope some of these groups will be doing the long-term analysis, right, of the things that we have been looking for with the PDA, neurodevelopment, chronic lung disease, especially in these little babies who are getting, you know, really early closure. Is it changing any outcomes? We'll see. Okay. I had a paper in a totally different, totally different sphere. Okay.

Ben Courchia MD (57:08.95)
That's right. That's right.

Ben Courchia MD (57:17.578)
We need to change the sphere anyway, so that's good.

Daphna Yasova Barbeau, MD (she/her) (57:21.063)
I think this is a paper that people have been waiting for and they're interested to hear, but it's got quite a blunt title. It's in the Journal of Perinatology, released this month, Academic Neonatologist Species at the Brink of Extinction? Bam, bam, bam. So this is the lead author, Dr. Bishop, who we know, who we interviewed.

Ben Courchia MD (57:39.15)
Bum bum.

Daphna Yasova Barbeau, MD (she/her) (57:49.583)
kind of part of the working group at the CHNC. So that interview is also available. And I'm not going to read you this paper. However, I think it covers a lot of the concerns that people are having, particularly in academia. So this increase in workload, increase in acuity, high administrative burdens.

All of these things are increasing and are, one, reimbursement and, two, clinical time are not being compensated adequately. So that's the first thing. The second thing is discussing what counts as scholarly contributions, what does a work

Daphna Yasova Barbeau, MD (she/her) (58:48.327)
does that look like? It's different depending on where you practice, how you practice in areas of the country. So they were actually quite transparent. They provided here this UC Davis neonatology work hour calculations, which again, we did discuss how to use the work hour calculations in that interview at the CHNC. And so I think people in the community are asking what...

what should my FTE look like? What does that look like in terms of research time versus administrative time, teaching time, clinical hours? So I think that they gave a nice description here. It shows also types of calls, and other nature of service type details that I think will allow other people to compare what their clinical time.

looks like. The other thing they discuss is really about neonatology as a whole, this concept about this financial inequity and the neonatology paradox, that are we being compensated less than our big pediatric or adult colleagues for the same or more work?

And so I think that this is an interesting paper for people to review, especially because you may have questions about your own clinical time and how does that factor in. I think it describes an ongoing challenge for everybody in medicine, especially neonatologists. We're pushing down the limits of viability, the complexity of patients that we provide interventions to.

And yet all of those other things, administrative duties, hospital committees, all of those things are going up. A lot of support personnel are being decreased in hospitals and those jobs are falling also on physicians. So I think it describes actually some problems in the entire community, not just the academic neonatologist we face.

Daphna Yasova Barbeau, MD (she/her) (01:01:06.071)
many of these same challenges in private practice as well, I think. So I think it's an interesting article for everybody to look at. What are your thoughts?

Ben Courchia MD (01:01:17.406)
Oh, I have thoughts. I mean, it's interesting to see that the model is becoming outdated because of outside factors, right? I mean, I think this is very interesting to see how, well, our hospitals are getting busier, we are working more, and we're being asked to do many more things. I think we're looking at the amount of burden that is placed on clinicians for documentation, for...

Daphna Yasova Barbeau, MD (she/her) (01:01:17.841)
I know you do.

Daphna Yasova Barbeau, MD (she/her) (01:01:28.652)
Right, that's right.

Ben Courchia MD (01:01:46.274)
presence at the bedside and these are competing with one another. And there's only so many hours in a day. And when you say, Hey, we need you to document more, be more present at the bedside, take on these six extra ICU patients. It's like when during the daytime can I do this with still having time to go to the restroom? Right. It's like, people don't realize like, yeah, doctors, sometimes you're like, I haven't had a chance to go to the restroom. Like I haven't stopped and I need to, right. I mean, this is basic human needs, right. And, and it's funny to me that

There was, it was interesting when that discussion came about regarding Amazon workers that they were saying, Hey, they're being asked to work so much. They don't have time to make it to the restroom. And this is appalling. And then, but somehow I was like, we often deal with this where it's like, I want, like, you want to go to the restroom, but it's like, Hey, I got to go at this bedside and I got to like, it's just nonstop. So, um, I think there's, there's tremendous concerns. And then on top of that, you have the demands of research where, and education. And I think to me that.

Daphna Yasova Barbeau, MD (she/her) (01:02:29.443)
Mm-hmm.

Daphna Yasova Barbeau, MD (she/her) (01:02:34.723)
Mm-hmm.

Ben Courchia MD (01:02:46.486)
resonated strongly because we do a lot of work ourselves, right? We're, we're, we're clinical neonatologist and they are certain endeavors that are requiring more than muscle memory, right? Uh, research is a creative endeavor. You need, you need to be awake. You need to be fresh. Um, and I think some of the times like we're post-call and I'm like, I just can't do that thing because it requires some kind of brain power that I don't have. Same thing with teaching.

Daphna Yasova Barbeau, MD (she/her) (01:02:58.479)
Mm-hmm.

Daphna Yasova Barbeau, MD (she/her) (01:03:02.701)
Yeah.

Daphna Yasova Barbeau, MD (she/her) (01:03:08.66)
Yeah. Attention. Yeah.

Ben Courchia MD (01:03:12.618)
When you teach, you should be present. You shouldn't be half asleep because you've been on like a 36 hour stint. And it's like, it's very, very tough. And then when you combine that with the fact that neonatologists are not getting paid nearly enough for all of this, um, it's hard. You're looking at being an academic neonatologist in Miami, Florida. It is ridiculously expensive to live in Miami, Florida. So it's, it's hard. It's making it not a very enticing.

path to follow and unless something changes, it's going to be a problem. So.

Daphna Yasova Barbeau, MD (she/her) (01:03:44.335)
Well, and that's, we're already there, right? We're seeing less people enter the field. Is it these reasons or something else? I don't know, but this isn't helping for sure. Yeah.

Ben Courchia MD (01:03:48.118)
Yeah.

Ben Courchia MD (01:03:56.622)
100%. And Satya has talked about this from a greater perspective in pediatrics in general. So I feel like as neonatologists, sometimes we're even a bit more fortunate than some of our colleagues. But still, it's very stressful. It's a lot of work and I'm not exactly sure how this is going to be sustainable. Yeah.

Daphna Yasova Barbeau, MD (she/her) (01:04:16.975)
But I do think there's this concept about, you know, our community's pretty small in terms of, let's say our colleagues in the US, let's say, who have a kind of similar stressors. You know, can we standardize what that looks like across the country and then say to hospitals, like, this is what the standard is across the country. And will that help?

Ben Courchia MD (01:04:25.995)
Yeah.

Ben Courchia MD (01:04:38.99)
I think unless until we have a, we have a discussion and a complete deconstruction and reassessment of how we measure productivity in our field, it's not going to happen because you cannot measure my productivity the same way you measure my wife's productivity in an office of cardiologists. Like it's just not the same, the same scale. It's just not like, right. You cannot talk to me about.

Daphna Yasova Barbeau, MD (she/her) (01:04:48.961)
Mm-hmm.

Ben Courchia MD (01:05:06.002)
Like it's always the same. It's like, oh, census is low. It's like, but isn't that good? Isn't that what we're trying to achieve? Like, oh, census, like it's, it's always about the census, but at the end of the day, it's like, well, what are we, what are we trying to do? So it's interesting. Yeah.

Daphna Yasova Barbeau, MD (she/her) (01:05:21.327)
very interesting, but it's a hot topic. People are always asking about it on all the social media platforms. They're talking about it in the workrooms. So I think this is a nice place where you can go and get some information, get some, a real example of at least one division's clinical work hours and how they divide that. And I think...

I mean, that's what really resonated with me when we spoke with the group at the CHNC is that this concept of transparency and not just transparency from one unit to another, one division to another, just transparency within a division. I think that was really eye-opening about how different, even within a division, for whatever reason, whatever those factors are, that one person's work.

counts more or less than another person's work. So.

Ben Courchia MD (01:06:23.618)
There's some shady things happening in some units. I'm just going to say it. I'm going to end on the lighter note because it's kind of, to me, like talking about this, it's a bit depressing.

Daphna Yasova Barbeau, MD (she/her) (01:06:24.395)
some shady things happening. Yeah, that's right. That's right. So transparency is key.

Daphna Yasova Barbeau, MD (she/her) (01:06:37.455)
But I think it represents that there is a recognition of the problem, yeah, and a shift. And hopefully as a community we can all work together to have better work-life balance, which is not just good for doctors, but it's also good for patients. So I think that's very, very important.

Ben Courchia MD (01:06:41.298)
an awakening.

Ben Courchia MD (01:06:48.598)
Mm-hmm.

Ben Courchia MD (01:06:58.414)
Being Dr. Daniel Rouch, who was my mentor in pediatrics, said having a liberal approach where you are monitoring things and you're not intervening is the most energy and resource consuming thing you could do. And it's true. Yeah, it's intensivist. But when you're tired and you get called and say, that kid's breathing and this is happening like.

Daphna Yasova Barbeau, MD (she/her) (01:07:14.435)
the, the Zen, the Zen, Zen-tensivist concepts.

Yeah.

Ben Courchia MD (01:07:26.166)
You're much more inclined to say, let's work this kid up. Like I'm tired. And like, yeah, when you're saying that, it's so true. We have all experienced it. You ask me something about a baby at the beginning of a 24 hour shift. You present me a problem at the end of a 24 hour shift. It's not 100% clear that I might respond in the same manner because you're tired. You're like, I can't, I don't have the mental bandwidth to keep up. Anyway.

Daphna Yasova Barbeau, MD (she/her) (01:07:27.235)
Just work them up, yeah.

Ben Courchia MD (01:07:51.426)
So this paper that I saw was in Acta Pediatrica. It's called Systematic Analysis of Adverse Incident Reports Revealed the Need for Improvement in the NICU. First author is Maria Karja-Lainen. It's out of Finland. This paper wanted to look at a few things. They wanted to characterize adverse and near-miss incidents in the tertiary level NICU. They wanted to analyze whether the reported incidents occurred more frequently outside of regular hours or during vacation.

than during regular business hours. They wanted to see what were the contributing factors to the incidents and they wanted to see recommendations given to prevent these incidents from occurring. The methods, it's a retrospective review of basically incident reports. I'm gonna skip that because we're way over time already. They looked at this from 2013 to 2020 and they found basically 11, 1,100 adverse incidents that were reported.

They excluded a few because they were not really processing. So they had about a thousand reports to look at. All right, let's look at some things. And we're gonna, I'm gonna ask you, you don't have the paper in front of you, right? No, good. Okay, unmute, because I'm gonna ask you questions. I'm just curious to hear, like, because it's, there's no right or wrong answer, but it's gonna be fun. So one third of the incidents were related to medication, fluid management, and blood products. And a third of these were classified as near miss.

Daphna Yasova Barbeau, MD (she/her) (01:09:03.105)
Okay.

Ben Courchia MD (01:09:16.118)
The most common subcategory of medication, fluids, and blood product incidents were either administering errors, followed by preparation errors, followed by dispensing errors, while 9.8% were prescription error. That's us. Paracetamol, morphine, iron, sulfate, vancomycin, and insulin were the most frequently reported medicines. And, but they're kind of some of them that we use quite frequently.

Daphna Yasova Barbeau, MD (she/her) (01:09:30.642)
and pharmacy a little bit.

Daphna Yasova Barbeau, MD (she/her) (01:09:43.971)
Great.

Ben Courchia MD (01:09:45.442)
But yeah, nursing practice and monitoring was the second most common type of incident followed by communication and device related incidents, respectively. Approximately two thirds of the reported incidents happened to the patient and 189 of these caused harm to the patient. Harm to a patient was minor in 165 cases, which I guess is better. And as a result, 23 adverse incidents, a patient suffered moderate.

Daphna Yasova Barbeau, MD (she/her) (01:10:14.987)
You thought this was the lighter direction? Yeah.

Ben Courchia MD (01:10:15.072)
Um

Yeah, because we're going to get, I mean, yeah. So who reports incident reports? Right. 89.5% is done by nurses. Other staff members report 6.5% of incidents and 4% reported by physicians. I think we don't do a good job at filing incident reports to try to help the culture of our units. I'm very much including myself in that bunch. Within

Daphna Yasova Barbeau, MD (she/her) (01:10:21.992)
Mmm.

Daphna Yasova Barbeau, MD (she/her) (01:10:39.997)
Mm-hmm. Yeah, I mean, sometimes we assign that task to somebody else, right? That's right.

Ben Courchia MD (01:10:43.574)
That's right. Within physician reports, 21% were near misses, while 35% of nurses reports and 50% of other professional reports were near misses. So it looks like our colleagues are much more likely to report near misses. So let's look at timing of incidents, which is why I wanted to sort of poll you a little bit. So which day of the week do you think has the lowest number of reported incidents in that finish?

Daphna Yasova Barbeau, MD (she/her) (01:11:13.34)
The lowest number.

Ben Courchia MD (01:11:13.714)
in NICU. Yeah.

Daphna Yasova Barbeau, MD (she/her) (01:11:17.783)
days.

Ben Courchia MD (01:11:19.894)
Mondays. So the lowest number of report incidents happen on the Wednesdays.

Daphna Yasova Barbeau, MD (she/her) (01:11:24.771)
Hmm. I mean, that makes sense. I'm thinking about it now. That makes sense. You've kind of settled into the week. You know, you know your patients. Yeah. Okay.

Ben Courchia MD (01:11:30.506)
That's right. That's exactly right. But then the incident reports were most numerous on Thursdays, followed by Saturdays, which Saturday I can get, but Thursdays, I mean, that's a bit peculiar. I'd be curious to see what their staffing model looks like. In terms of months of the year,

Daphna Yasova Barbeau, MD (she/her) (01:11:53.143)
I find that. I find it. Who's doing incidents? I guess. I feel like lots of incidents happen on the weekends, but I feel like most of those reports don't get filed until the weekday.

Ben Courchia MD (01:12:04.822)
That's right. The lowest number of incidents reports were filed in February. And I'm like, could it just be that there's less days in the month? That's possible. I think that the month after that, that's sort of the lowest is October. But what's interesting is that compared with February, there were significantly more reports in June here without what you wish.

November and December. So by the end of the year, we're all mailing it in, I guess, until Christmas season comes around. In terms of shift and the time of day, 43% are reports are filed from 7 a.m. to 3 p.m. And then only 30% are filed in the evening shifts. That's from 3 p.m. to 9 p.m. So most of the most so that's 70% almost like most of them are filed

And then from 9 p.m. to 7 a.m., only 25% of incidents reports are filed then.

Daphna Yasova Barbeau, MD (she/her) (01:13:05.727)
Yeah, I guess my question for that is, is that when the problem occurred or is that just when people are filing? I mean, that's assuming that you did the incident report exactly when it happened. Okay. Huh.

Ben Courchia MD (01:13:14.231)
That's a good question.

Ben Courchia MD (01:13:18.758)
No, the incidence occurred. I think it's the incidence occurred. I think that's what they say. Now the proportion of near-miss incidence and incidence that happened to a patient remained the same during different weekdays, months, and working shifts. And there are several contributing factor for some of the incidence which were recognized in about half of the reports. The most common factor were the following. Working practices in 18%.

work environment, tools and resources, and the communication or transfer of information in 14% of cases. And God knows that this is something that we could all always improve on. The educational orientation or competence of personnel was insufficient in only 8% of cases and patient or family contributed to the incidents in seven reports. That's frightening. I don't know what that means. Hopefully nothing too bad.

Daphna Yasova Barbeau, MD (she/her) (01:14:09.483)
Yeah, what were those?

Ben Courchia MD (01:14:12.726)
What is the most common thing that happened after incident reports? In 60%, the most common intervention after an incident report was to discuss or inform the unit staff. And after 8.6% of reports, it was informing a party or actor outside the NICU that was recommended. 6% of reports resulted in recommended improvements, which that's interesting, right? I would expect that number to be much higher.

Daphna Yasova Barbeau, MD (she/her) (01:14:38.523)
Yeah.

Ben Courchia MD (01:14:40.93)
These included training of the staff, creating new checklists, standardized operating procedures, and malfunctioning device were updated or replaced after an incident where they had an incident with a neurogastric tube. So the conclusion of the paper is that medication error are the most common type of reported adverse incidence, and that most administering error cause adverse events to the patient. I mean, I would not have expected that, obviously.

Daphna Yasova Barbeau, MD (she/her) (01:15:05.678)
Mm-hmm.

Ben Courchia MD (01:15:06.678)
The frequency of adverse events report varies depending on the time, possibly the month of the year, and recognizing the contributing factors of adverse incidents may help you planning for improvements. And I think that's very true. Like you were saying, we're not super transparent. I don't know what that data looks like in our unit. And it's nice, number one, that they were doing this work of looking at this and also the fact they're publishing it is super interesting. So, yeah, I mean, it's kind of interesting to see.

I mean, let's be honest, every unit, no matter where being looked at, here's my conclusion for this paper. Medicine looks at the NICU as one of the most high functioning places in the hospital. But neonatologists look at NICU as some of the most dysfunctional places. Like we all feel like our NICUs are dysfunctional. We're like, oh, we don't have this and we never get this on time. Right. And. Right.

Daphna Yasova Barbeau, MD (she/her) (01:15:41.688)
Mm-hmm.

Daphna Yasova Barbeau, MD (she/her) (01:15:55.935)
I think we have high expectations for our high-risk babies. I don't think there's anything wrong with pushing the envelope a little bit.

Ben Courchia MD (01:16:05.61)
It's funny because when my wife catches me discussing stuff and she's like, and I'm like, oh, wasn't the dose supposed to be 6.5? Why did they send six? Right. And I was like, does that make a difference? I'm like, yeah, it makes a huge difference. And so we, yeah, we set, uh, we set high expectations for ourselves and we always feel like, I mean, if I give you a whiteboard and I told you what could you fix about our unit, you would fill that board within 30 seconds. And I feel like everywhere I've been, it's the same. We always have like a long.

Daphna Yasova Barbeau, MD (she/her) (01:16:17.113)
in these little tiny people, yeah.

Daphna Yasova Barbeau, MD (she/her) (01:16:32.531)
Yeah, that doesn't mean that the unit's dysfunctional, and it doesn't mean that anybody's doing anything wrong. There's just always room for improvement.

Ben Courchia MD (01:16:38.742)
No, no, no. Right. But it's interesting to then look at it from...

Daphna Yasova Barbeau, MD (she/her) (01:16:42.703)
And especially, I think, I mean, I think around medication errors, right? I mean, that's something where we have enough technology and in information about human function, that like we should be able to keep medication errors from happening, but they keep happening.

Ben Courchia MD (01:16:55.342)
That's right.

Ben Courchia MD (01:17:06.574)
Absolutely.

Daphna Yasova Barbeau, MD (she/her) (01:17:07.407)
I think that's it, buddy.

Ben Courchia MD (01:17:09.426)
Yeah, I think that's good for today. I'm tired now. All right, I'll see you next week. Take care, bye.

Daphna Yasova Barbeau, MD (she/her) (01:17:11.503)
Okay. I know. All right.