#364 - 📑 Journal Club - The Complete Episode from October 5th 2025
- Mickael Guigui
- 1 day ago
- 48 min read
Hello friends 👋
In this Journal Club episode, Ben and Daphna review a wide range of new research shaping neonatal practice and policy.The discussion begins with a randomized controlled trial from Korea examining antenatal corticosteroid use in twin pregnancies at risk for late preterm delivery, showing reductions in neonatal respiratory morbidity. They then turn to a meta-analysis on DHA with or without ARA supplementation in preterm infants, where results raised concerns about potential increased risk of BPD, highlighting the need for more precise dosing and study design.
A major feature of this episode is the release of the Improving Neonatology Staffing Toolkit, presented with guests Dr. Kerri Machut and Dr. Milenka Cuevas Guaman. They explain how the toolkit builds on consensus recommendations to offer practical guidance, case studies, and advocacy resources for units of all sizes.
Ben and Daphna also review a multi-center study comparing transcatheter closure and surgical ligation of the PDA in extremely preterm infants, finding similar neurodevelopmental outcomes at 2 years. Additional topics include an analysis of opt-out consent in neonatal trials, new data on the association between critical congenital heart disease and infant cancer, and a systematic review of autism screening tools for preterm children.
A dense episode full of data and practical implications for neonatology.
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The articles covered on today’s episode of the podcast can be found here 👇
Lee SM, Park HS, Choi SR, Lee J, Kim HJ, Park JY, Oh KJ, Cho GJ, Oh MJ, Chung JH, Kim SM, Kim BJ, Kim SY, Hong S, Jung YM, Lee SJ, Seong JS, Kim H, Oh S, Lee J, Jin YR, Kim JH, Cho HY, Park CW, Park JS, Jun JK.JAMA Pediatr. 2025 Sep 22:e253284. doi: 10.1001/jamapediatrics.2025.3284. Online ahead of print.PMID: 40982289
Dang D, Gao Z, Zhang C, Mu X, Lv X, Wu H.Arch Dis Child Fetal Neonatal Ed. 2025 Apr 15:fetalneonatal-2024-327606. doi: 10.1136/archdischild-2024-327606. Online ahead of print.PMID: 40233974
Kaluarachchi DC, Chock VY, Do BT, Rysavy MA, Sankar MN, Laughon MM, Backes CH, Colaizy TT, Bell EF, McNamara PJ, Hintz SR, Natarajan G.J Perinatol. 2025 Sep 23. doi: 10.1038/s41372-025-02417-8. Online ahead of print.PMID: 40987835
Mitchell T, Andrzejewska I, Battersby C, Cole C, Daskalopoulou Z, Dorling J, Gale C, Graham M, Hubbard M, Hardy P, Hurd M, King AR, Manley BJ, Murray D, Nuthall E, O'Connor H, Ojha S, Roberts CT, Rodriquez A, Roehr CC, Stanbury K, Tume L, Young L, Woolfall K.Arch Dis Child Fetal Neonatal Ed. 2025 Aug 31:fetalneonatal-2025-328693. doi: 10.1136/archdischild-2025-328693. Online ahead of print.PMID: 40889884
Chin S, Lupo PJ, Baer R, Hobbs CA, Chambers CD, Bandoli G.Pediatrics. 2025 Sep 25:e2025072934. doi: 10.1542/peds.2025-072934. Online ahead of print.PMID: 40992753 No abstract available.
Thomas KE, Raghuram K, Banihani R, Church PT, Mbuagbaw L, Penner M.Pediatrics. 2025 Sep 3:e2024069837. doi: 10.1542/peds.2024-069837. Online ahead of print.PMID: 40897396
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Watch this week's Journal Club on YouTube 👇
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The transcript of today's episode can be found below 👇
Ben Courchia (00:00.674)
Hello everybody, welcome back to the incubator podcast. We're back today for an episode of Journal Club. Daphne, good morning. How are you?
Daphna Barbeau (00:07.258)
Good morning, good morning. We love doing journal club, don't we? We want to do more journal club.
Ben Courchia (00:11.746)
Yeah, yeah, we, there will be more Journal Club. I mean, I think that towards the end of the year, we can do a little special episodes to announce how the lineup is going to evolve for 2026. I think people are going to be happy. mean, all the changes that we make to the incubator series, to the incubator lineups are based on feedback that we receive from the community. And if it, I don't want to be too cryptic, we're not really...
taking away anything. think we're reorganizing the structure of the podcast so that people can access the episodes more conveniently. Another piece of feedback that we received over time. yeah, in the end though, while we're not taking away anything, there will be more Journal Club and there will be more accessible, I guess, in a way. In the meantime, I highly encourage people to check out the website. We have done...
Daphna Barbeau (01:03.002)
Mm-hmm.
Ben Courchia (01:10.734)
You have done a very good job as a team. I want to compliment Michael and the rest of the team for organizing all the papers. you'll see that number one, can select in the podcast page all the journal club articles. And then if you actually want to go by organ system, you will have the individual papers and it will lead you to the audio directly if you want to listen to specific papers. So it really is well made. I didn't make it, but it's what made.
Daphna Barbeau (01:17.882)
Mm-hmm.
Daphna Barbeau (01:39.898)
We've got a good team. We're lucky to have a good team.
Ben Courchia (01:42.804)
Yeah, yeah. I felt like Steve Jobs for a lot of this where I'm like, let's do this. And then they made it happen. And I didn't really know how this was going to work, but it worked. yeah. Today we have a few announcements as well that we wanted to talk about. Number one, we have a special segment probably midway through the episode where we're going to...
Daphna Barbeau (01:48.026)
They made it happen.
Ben Courchia (02:08.534)
Welcome back to the show, Kerry and Melenka to talk a little bit about the staffing toolkit that was recently released on the section's website. Definitely you need to know about this because everybody is always complaining and whining about staffing and about the structure of specific divisions and how do we handle certain things. They actually did the work and it outlines basically how a unit should be.
Daphna Barbeau (02:10.554)
Mm-hmm.
Ben Courchia (02:37.206)
organized. So we'll talk to them. They'll tell us a little bit of what they've done, how everything is structured and so on and so forth. So that's very exciting. The other thing that I wanted to mention, Daphne, there was something else. We won't really have an EB-Neo segment. That being said, the EB-Neo team is in the process of selecting the impact article of the year for 2024.
Daphna Barbeau (03:03.226)
Mm-hmm.
Ben Courchia (03:06.23)
So looking at the articles published in 2024 that have had the most impact in clinical practice, I believe that they had a lot of articles to start with. And currently, we have eight finalists. And I'm just going to run through the eight finalists so that you know. One of these articles is the effect of early versus late inguinal hernia repair in primis.
Daphna Barbeau (03:17.466)
Mm-hmm.
Daphna Barbeau (03:21.582)
right.
Ben Courchia (03:31.446)
Another one was the trial of selective early treatment of the PDA with ibuprofen. Another one was video versus direct laryngoscopy for urgent intubation. Another one was the PLOS trial about intratracheal butasinide mixed with surfactant. We spoke to Brett Manley about this on the show. Then there's a cluster randomized trial of xylitol chewing gum for prevention of preterm birth.
Then there's ventilatory assistance before umbilical cord clamping in extremely preterm infants. Then there's the trial about near CVMAP for the prevention of hospitalization due to RSV. And finally, the STAT trial, stoma or intestinal anastomosis for necrotizing enterocolitis. All these articles, by the way, if you look them up on our website, BISYSTEM, you can find them and we've reviewed them. And then maybe you can listen to the ones that I've just listed and then make a decision and then cast your vote for the impact article of the year.
Daphna Barbeau (04:16.377)
Hmm?
Ben Courchia (04:25.902)
for 2024.
Daphna Barbeau (04:26.007)
Yeah, many of them we reviewed and we had the EBneo commentary.
Ben Courchia (04:29.774)
That's correct. Yeah, that is correct.
Daphna Barbeau (04:34.403)
So people should go to the website then to vote.
Ben Courchia (04:38.232)
to the eBeneo website. eBeneo website, eBeneo, Twitter page, they're posting about it all over the place. There's a link. And yeah, go do that.
Daphna Barbeau (04:49.293)
Yeah, I think the easiest way is probably go to abneo.org backslash impact. And then you can literally select, they want you to select your top two finalists. And then we'll go from there.
Ben Courchia (05:00.94)
Yeah. Okay.
Daphna Barbeau (05:02.605)
Very cool. Do you have a, do you have a front runner?
Ben Courchia (05:05.794)
Do I have a front? You're asking me a tough question here.
Daphna Barbeau (05:09.815)
I didn't warn you that I was gonna ask you.
Ben Courchia (05:11.682)
I would say near save a map. Near save a map is a game changer.
Daphna Barbeau (05:17.079)
Yeah, very exciting. actually, so, go ahead.
Ben Courchia (05:18.412)
I think that if you are, yeah, no, if you're like me and you trained some time ago, not too long ago, like, no, but I mean, you remember this, Daphne, like September would roll around and you know that on the pediatric floors, that was going to be RSV. Like everybody had RSV and these kids were hospitalized and God forbid you were on pick you call. Some of these kids are like, I mean, I've had babies with RSV, children with RSV that I'm like, I hope this kid makes it through the night. And it was terrifying. And so when you look at these numbers and the reduction in hospitalization,
Daphna Barbeau (05:24.867)
Some time ago, old timer.
Daphna Barbeau (05:30.488)
Mm-hmm.
Daphna Barbeau (05:43.993)
Mm-hmm. Mm-hmm.
Ben Courchia (05:49.312)
I mean, I'm not dismissing the other papers, but man, you're saving my
Daphna Barbeau (05:56.974)
It was interesting, I saw our colleague, Joanna and her colleague also podcasters at the AAP conference and they were asking people, if you could be any vaccine, which one would you be? And the front runner was some combination of the RSV vaccine, but nurse of the map for sure.
Ben Courchia (06:10.689)
Okay.
Ben Courchia (06:20.398)
I I'm still a sucker for the aura and the legacy of the polio vaccine. I think that if you read, I mean, I would recommend the following book. The Vaccine Race is a great book. Give you a little bit of perspective. Again, another book that we reviewed on the podcast is called A Good Time to Be Born. I think we don't understand what was the implication of some of these
Daphna Barbeau (06:27.225)
Of course, of course.
Daphna Barbeau (06:34.201)
Mmm.
Daphna Barbeau (06:41.078)
Mm-hmm.
Daphna Barbeau (06:45.027)
Yeah.
Ben Courchia (06:48.694)
disease and how it affected families and how it ruined lives and that when these vaccines came out, sometimes one after another, like people were clamoring. were like, my God, this is over. Yeah. And and yeah, and yeah, I saw that. think I think is I think it's in Israel that they've moved up the measles time for vaccine because they're getting they're getting too many cases. And so they're going to start vaccinating earlier. How crazy is that?
Daphna Barbeau (07:16.921)
Huh, that makes sense in a public health move.
Ben Courchia (07:21.07)
Yeah, 100%. But I mean, it's just, just anyway, it's not a vaccine talk. This is Journal Club. So.
Daphna Barbeau (07:27.801)
It's It's journal club. Go vote for the EVneo Impact article of the year. And so there's no confusion. This is 2025, but we're voting for articles from 2024 because it's the full year. So I don't want people to go in, log in and be like, this isn't the right poll. Just, just so people know.
Ben Courchia (07:46.68)
Yeah, the articles, you have to give them some time to have their impact. That's the key. right. Daphna, we're going to start. I guess I'm going to get us started, if you don't mind. That's usually, we usually have a conversation about all this and I still get to start. So I'm going to just start. The paper I wanted to review first was a paper that I saw in JAMA-PEDS called Antinatal Corticosteroid in Twin Pregnant Women at Risk for Late Preterm Delivery. This was an article that really piqued my interest.
Daphna Barbeau (07:49.623)
That's right. That's right.
Ben Courchia (08:17.914)
Because we know that compared with Singleton, twin pregnancies are at high risk of preterm birth, of morbidity, and unfortunately, mortality. And in fact, preterm birth rate in twin ranges from 37 % to over 60%. But most of them, which is kind of a frightening number, but most of them are late preterm births, meaning that they deliver around 34 or 36 weeks gestation. Now, we know from several trials, including the
Alps trial that if we give beta methazone steroids to women who are at risk of late preterm birth, it reduces the need for respiratory support in their newborn. And so there are recommendations for single term pregnancy to do that when you're for these particular pregnancy. there's a question. The Alps trial didn't really look at twin gestation. And we really don't have good evidence to guide the practice in this particular population. And they have
This is a population that has a high rate of C-section, a high rate of neonatal respiratory morbidity. And there some questions around the long-term effect of steroid use. So what should we do in terms of late preterm twins? So the question that the group is asking, the group is led by Si-Yong Mi-Lee. It's a group out of Korea. We don't review papers from Korea that often. So it's always nice to represent other areas of the world. Does giving antenatal beta-methasone to women with twin pregnancies at
risk of late preterm delivery reduce severe neonatal respiratory morbidity. So this was a multi-center, randomized, double-blind placebo control trial that was conducted within a network of eight university hospitals in Korea between 2018 and 2024. So in terms of the patients that they recruited,
They eligible patients were mothers who were having twin pregnancies between 34 and 36 weeks and five days and who were judged to be potentially at risk of preterm delivery. Now, that could be because they had preterm labor, because they had premature rupture of membrane or cervical insufficiency, or they had something fetal like IUGR or oligohydramnios, maternal issues like hypertensive disorders.
Ben Courchia (10:38.334)
and so on, or complications of twin pregnancy. Now, these mothers were randomized on a ratio of one to one to receive either the two IM doses of bitometazone, given 24 hours apart, or two placebo injections of normal saline. I'm afraid of needles, that fucking sucks if you get two shots and they're not even the med. Otherwise, all the patients received standard prenatal care. The outcomes that were looked at, the primary outcome of the study was perinatal death
within 72 hours of birth or severe neonatal respiratory morbidity, which was defined as needing either CPAP or high flow nasal cannula for 12 hours or more, having an FIO2 requirement of 30 % or more being on mechanical ventilation or needing ECMO. There's lots of secondary outcomes that they looked at, milder respiratory morbidities like TTN, CPAP for less than 12 hours, et cetera, et cetera. So this was the study.
They're obviously a very interesting question.
So 831 women were randomized. And after some withdrawal, 812 remained, 410 in the intervention group, 402 in the placebo group. The median gestational age at enrollment was about 36 weeks. And the delivery occurred at a median of 36.4 weeks. I feel like all the twin pregnancies, when they deliver, naturally it's 36 and something.
Over 77 % of pregnancies were achieved through assisted reproduction, which I think is an interesting statistics, and about 19 % were monochorionic. So looking at the outcomes, the primary outcome, the composite of death or severe respiratory morbidity occurred in 4.8 % of neonates in the beta medicine group compared to 7.5 % in the placebo group, which was a statistically significant difference.
Ben Courchia (12:34.862)
The relative risk was 0.64 and the confidence interval of 0.4 to 0.98. Now looking at the components, it's the need for CPAP for 12 hours or more that was lower by almost half in the beta-methasone group at 2.4 % versus 4.7 % in the placebo group. And overall, when they were looking at sort of the number needed to treat the authors calculated that treating 23 pregnancies with beta-methasone would prevent one case of the primary outcome.
Ben Courchia (13:06.781)
which I think we can have a debate about whether that's a large number or not. In terms of secondary outcomes, mild respiratory outcomes also improved. CPAP for at least two hours was lower in the beta-methasone group, 3.4 % versus 6 % in the control. Also transient tachypnea of the newborn was lower, 2 % in the beta-methasone group compared to 4.2 % in the placebo.
That said, was a trade-off. Hypoglycemia was a bit more frequent in the beta-methasone group, 15.6 % versus 11.7 % in the placebo. Also, feeding difficulties were less common with the beta-methasone group, probably related to respiratory comorbidities, I assume, compared to placebo. Now, what's interesting is that, according to the authors, the timing of the administration did matter, something that we know to be true for singleton pregnancies as well.
When they looked at the interval between the steroid administration and delivery, the benefit was really concentrated in neonates who were delivered 12 hours to seven days after the first dose. In that window, the risk of the primary outcome was reduced by relative risk of 0.56, and no benefit was observed if birth occurred sooner than 12 hours or more than seven days after treatment. The rates of maternal complication did not really differ between the two groups. And so the conclusion of the article is that in this randomized
clinical trial, antenatal methamphetazone administration in twin pregnant individuals at risk of late preterm delivery reduced the risk of neonatal respiratory morbidity and that antenatal corticosteroid injection should be recommended in this population, which I think is very interesting because some people might say that it's kind of like what we know to be true for singleton, but we're trying, feel like we're reluctant.
Daphna Barbeau (14:46.861)
Mm-hmm.
Ben Courchia (14:59.448)
to remain in this particular position for Singleton. We're trying to move away from that in terms of Singleton pregnancy, trying to give less steroids. But it looks like for twins, it's a good idea. I don't know. I don't know what you think.
Daphna Barbeau (15:14.551)
Yeah, I mean, think twins are not the same as singletons, you know? And I think we're learning more and more about that. We're going to talk a lot about twins at the Delphi Conference, you know? And I think that's, it's the reason we picked the topic is because, you know, they're admitted together and we compare them a little bit during rounds. But, you know, physiologically, the whole system is different than in a singleton pregnancy. So I think we're going to be learning a lot more about twins.
Ben Courchia (15:17.774)
Nope.
Ben Courchia (15:25.42)
Yeah.
Daphna Barbeau (15:44.235)
So, all right, more beta-mythosome, I guess.
Ben Courchia (15:50.668)
Yeah. All right. What are you taking us to next?
Daphna Barbeau (15:53.944)
Okay, I was very intrigued by this paper, Effective Enteral Supplementation of DHA with or without ARA and Preterm Infants of Meta Analysis. This is a paper out of China. And so they wanted to look at a supplementation of additional DHA, I'm gonna say it, DECO. I have practiced so many times, DECO.
So hexionic acid with or without arachiodonic acid, ARA. And how does that influence like individual neonatal morbidities that we often diagnose in the NICU? And the point really about the question is that prematurity itself kind of disrupts this obviously natural supply of maternal essential fatty acids that come across the placenta.
So perhaps if we reestablish that supply, might that help in some of these neonatal morbidities? And as a reminder, we're talking about these polyunsaturated fatty acids, the PUFAs, they play a pivotal role because they are essential nutrients. They do come through breast milk. They are seen in formula and lipid emulsions.
And specifically we have interest, these are on the boards for sure, the linoleic acid and the alpha-linoleic acid, essential fatty acids that require this exogenous intake. Now they're specifically talking about DHA and ARA. They are downstream metabolites of linoleic acid and alpha-linoleic acid. And so if you have those essential fatty acids, you can synthesize them or they can be supplemented.
And we know there's a lot of data about how DHA is important for brain development, vision, cardiovascular health, it's being added to lots of term supplements for babies. And AERA also plays a big role in inflammation, immune function, and cell membrane integrity.
Daphna Barbeau (18:06.189)
They were hopeful that adding these things would be helpful. So this is actually a meta analysis, like I mentioned. Yes.
Ben Courchia (18:12.76)
May I say something? If you are interested in learning more about DHA and ARA, then maybe take a break now and go listen to episode 274, which is a conversation that we had with Dr. Cammie Martin from Cornell about specifically this topic as she was going to do this review for the Neonatal Insider course. So it was a great review. She goes over everything and she's obviously so good at
Daphna Barbeau (18:16.398)
Mmm.
Daphna Barbeau (18:35.991)
It was a great, it was a great talk. We learned a lot, didn't we? Yeah.
Ben Courchia (18:41.9)
teaching that yeah. So yeah, just go check this out and then you can come back and then you can see what the data actually shows based on this particular paper because it's a very interesting conversation.
Daphna Barbeau (18:55.545)
Yes, and if you plugged in DHA into the website, we've reviewed about five other papers interested in DHA. So what they did, they included randomized controlled trials. They wanted to focus on the preterm infants. So they really only included studies that had babies with gestational age less than 34 weeks or birth weight less than 2,000 grams.
They didn't specify whether or not maternal supplements were included and notably in the intervention group. So infants received an oral DHA with or without ARA. They looked at them as one whole group and then they did some subgroup analysis. These babies would have gotten the supplements within 28 days of birth and the control group received either placebo or standard intervention.
no additional supplementation. And then I think it's important to note there were no specific requirements for dosage or duration of the intervention. So different papers had different doses and they are varied and the length of treatment is also quite varied. get into that. The outcome measures focused on these kind of early complications of prematurity. So they wanted to look at BPD, ROP, NEC, sepsis, IVH, PVL,
and in-hospital mortality. So eventually they pulled 14 articles representing 11 unique trials. This included a cohort of 2,567 preterm infants from 10 different countries. Nine studies looked at BBD, eight studies looked at ROP, 10 on NEC, eight on sepsis, seven on IVH, four on PBL, and four included in-hospital mortality.
So now the dosage. So the dosage of DHA varied across studies from 20 milligrams per kilogram per day to 1.2 grams per day. The ARA doses range from 40 milligrams per kilogram per day to 240 milligrams per kilogram per day. So a lot of variability in dosage itself. And then intervention timeframe typically began within the first seven days of life and continued for...
Daphna Barbeau (21:16.056)
14 days or up to 36 weeks or to 40 weeks or till discharge. So a lot of variability in how long the infants were exposed to DHA plus or minus ARA. So first they wanted to look at kind of the overall group on early complications. So notably the...
They looked at these nine studies with 2,272 infants looking at BPD. And the cohort of these analysis indicated an increased risk, actually BPD associated with supplementation, a risk ratio of 1.11. Though notably the confidence interval is one to 1.22. They had five studies.
On any ROP, they found no significant link between DHA with or without ARA. The 10 studies involving 2,400 babies showed no correlation with NEC. The eight studies involving 2,200 infants showed no link with sepsis. Seven studies involving, again, 2,200 infants showed no connection with IVH. The four studies looking at about 1,800 infants, no relationship with PBL.
And the analysis of the four studies involving about 2000 infants did not affect in hospital mortality rates. So the only thing that showed kind of any difference was this BPD and actually showed an increase of it to increase the risk of BPD.
So then they wanted to look at the kind of subgroup analysis. So they showed that there was an increased risk of BPD in preterm infants in the DHA group alone. However, the risk of BPD did not increase in the DHA and ARA group. There was no correlation observed between DHA. So again, DHA versus DHA plus ARA.
Daphna Barbeau (23:33.059)
groups and the occurrence of any of the following ROP, NEC, sepsis, IVH, PBL, or in-hospital mortality. They did also look at stratified groups based on high dose and low dose DHA with or without ARA, and they showed that the risk of BPD was further increased in the high dose DHA group. The low dose group did not show statistically significant increase, but there was, they said, quote, a trend.
towards higher risk, but that confidence interval also crossed one. No correlation observed between DHA dosage and occurrence of ROP next, sepsis, IVH, PVL, or in-hospital mortality. They also looked at these disease processes by severity, and they showed that supplementation with DHA with or without ARA both increased the risk of the more severe forms of BPD, moderate to severe BPD,
Risk ratio of 1.1, again, confidence interval 1 to 1.24. No correlation between the supplementation and the occurrence of the highest severity of the other comorbidities. So ROP requiring therapy, Bell stage two or higher neck, or grades three or four IVH. So I think we're all hopeful that some of these additives will help. This is not what was found in the meta-analysis.
But also I think the dosages were quite varied. think the timeframes are varied. I'm not sure what we can surmount.
Ben Courchia (25:07.478)
I mean, that is, to me, is an incredible sort of situation in neonatology where the preliminary data seems to point unequivocally that like, have less of this, it's bad. And then the logical follow-up would be like, well, if I replenish, that should be good. But it's like, we don't see it. We don't see it with maternal supplementation. We don't see it with baby supplementation. And it's like, why? Why is that?
Daphna Barbeau (25:19.16)
100 % yes.
Daphna Barbeau (25:26.88)
Shouldn't it get better? Yeah.
So frustrating. Yeah.
I know. I know. So frustrating.
Ben Courchia (25:38.198)
Like you said, maybe we're just not doing it right. there's a regimen, a way in which we administer this, the dosages, the frequency, something that could potentially make this a little bit better. But how interesting. And again, if you are...
Daphna Barbeau (25:55.191)
Yeah, and I think it would have been interesting to stratify maybe by gestational age or weight or growth restriction. Maybe there are these groups of babies that really need it.
Ben Courchia (26:00.291)
Yeah.
Ben Courchia (26:07.094)
Yeah, and to me, the last thing I was going to say is that if you are a young researcher looking for something to do, like how ripe is this particular subject for like some sort of investigation? Yeah, absolutely. Yeah, give Cami a call and set yourself up.
Daphna Barbeau (26:15.32)
For sure, for sure. Career defining, I think, yeah.
Daphna Barbeau (26:24.024)
Sign up.
Ben Courchia (26:27.17)
That's right. All right, we're going to take a quick break for a little commercial break, and then we will be back with our conversation with Keren Mashut and Milenka Kouavas-Gouman about the Neonatal Staffing Toolkit. We'll be right back.
Ben Courchia (00:01.262)
Today on our episode of Journal Club, we're very excited to have with us repeated guests from the podcast, Dr. Keri Mashut and Milenka Kwevaskwaman. Milenka, Keri, welcome back to the podcast.
Kerri Machut (00:14.749)
Thanks for having us.
Milenka Cuevas Guaman (00:14.974)
Hey babe, thank you.
Ben Courchia (00:17.646)
We're very excited to have you on because we are talking about the INS toolkit, the Improving Neonatology Staffing Toolkit, something that we have covered on the podcast before, an initiative that you guys have been hard at work on and with an amazing group of colleagues and physicians. But the toolkit is out and it is available and it is phenomenal. Can you guys tell us a little bit, maybe,
Kari, do you want to just maybe remind people what the toolkit is and what is its intended goals?
Kerri Machut (00:54.737)
Yes, thanks, Ben. This grew out of the same work that hopefully a lot of our listeners have already heard from the Improving Neonatal Staffing Initiative. This was an effort that really grew initially out of the WIN group, the Women in Neonatology Advocacy Group, but then was quickly supported with a strategic grant from the section, thanks to Malenka Cuevas-Gwamen, my partner here on the talk, who was the PI for that.
And with that, hopefully the listeners all saw the main initial effort that we put forth was a lot of investigative work. And from there, what we learned in those research studies, we took and developed the consensus recommendations for best staffing practices with a summit and then put forth a paper that came out in May in pediatrics with those consensus recommendations.
We had a lot of support in that endeavor. We had a lot of experts that we brought in as advisors on the grant at various levels and leadership to help kind of shape that process, as well as some early career representation. We spent a lot of time building those recommendations with pretty rigorous methodology using the Delphi process, but we really then knew that that was just gonna be one step in the process and that.
for change to really happen in terms of staffing reform, individual institutions and centers would need some tools to help make that change happen at their center for physicians to really feel the impact of them locally. So we basically framed out the toolkit, and maybe Malika can talk about that next, based on those guidelines and kind of looking at the various things that were.
recommended in those guidelines and then trying to build on that with some very practical tools. But again, this was all still supported by the AAP section with the strategic grant. A lot of different people went into the design of the content that were advisors in our group. We sourced examples from various centers around the country from places that had good models of different ways to do various aspects of staffing, input on how to do needs assessments and things like that.
Kerri Machut (03:02.083)
And then the grant supported the design from a graphic design arm that we used to help kind of build it out and make it user friendly.
Ben Courchia (03:13.922)
Yeah, I the toolkit is very well designed. It flows very nicely and it has a broad scope. So, Melenka, maybe you can tell us a little bit about what people can find in the toolkit and what is the purpose of the toolkit and how people are supposed to use it within their own institution.
Milenka Cuevas Guaman (03:33.588)
Yes, so I think a couple of things is that like looking at it broadly, we're gonna start with the background, we're gonna bring you by the recommendations, stuff in practice that we published in Pre-Diagnostics, that Kerry just talked. And then we're gonna dive in, okay, how can you implement these recommendations? And so we're gonna guide you through assessments, we're gonna guide you through some practical solutions, we're gonna give you some implementation science and case studies.
and then we finish up with a little bit of advocacy. So now the important thing about how to implement or how to use it is we are kind of divided in two groups if you think about something that is very general and that is like what are the guiding principles that you need to consider to make whatever change you make sustainable moving forward. And those are four guiding principles. It has to be transparent, it has to be equitable.
it has to be adaptable and has to be democratic. And we'll guide you through all of those four principles. What it means for a big group, what it means for a small group, what it means for a group that is maybe private practice that is just by itself, or what it means if you're in academic place. So you need to be looking at how other groups within the academic place and working, right? When you look at their equitability, transparency, democratic and adaptability.
So you need to look at where you live. you kind of look at your microenvironment and then your macroenvironment. But then we kind of try to dive in a little bit more into specifics. And so that's when it comes to assessments. OK, we gave you these many recommendations, right? We don't expect you to come and say, OK, this year we're going to do all of these. No, just like we do in neonatology, there are several papers that come up, right?
and then you don't say, okay, I'm gonna implement all of these new things that come up. You just need to get together as a group and decide what of those things are important for your group because some of the recommendations might not apply to your group. So that comes the assessment, right? And it's assessment that is, what we're talking about democratic is everybody should have input. It shouldn't be just one, two, three people that decide everything.
Milenka Cuevas Guaman (05:52.552)
and then it should be democratic. Everybody should decide what's the goal for the entire department. And sometimes, you know, it might be the weekends, it might be the nighttime, it might be the daytime, but just come up together and try to come up with what are gonna be your goal in the next five years. Because we do understand that this is not gonna change from next candleland year, it's gonna be fixed. No, this is gonna be a process. And so you as a group, and it has to be adaptable. So, okay, we get COVID.
pandemic, something else happens, right? In the next two or three years, can you adapt, right? Can you adapt? Can you change? Can you see? Or you have a lot of exodus of people or changing in people, new grads, more grads, older grads. Then in three years, you're have to sit down and maybe your goals are gonna change. And so you need to implement according to all of that. And then one, don't know, that's gonna give you transparency, right? Transparency and
it's going to be equitable because everybody has a voice too, right? And then you can see, I think one important thing that we try to tell everybody is that as you build this, you need to be able to communicate and hopefully you can bridge the gap that we've been finding that, you know, we have kind of the new grads mode of thinking and what we have the old grads.
kind of way of thinking, right? None is correct. We just have to mix it and try to understand it and try to build something together. And also think about the future, right? Because there's gonna be a new generation that is coming that we somehow we need to encourage them to enter pediatrics, to enter neonatology. And so if we don't change now, then when? And so a lot of those things are gonna go into the assessment, it's gonna go into the implementation science. Like Kerry mentioned, we...
we kind of outsource, okay, anybody that we know that is working on a schedule that has a different kind of schedule or by points, by different categories or is in private practice or it's in academics, we kind of ask them, hey, how you do this? Do you mind sharing? And so we have different models. No one is perfect. No one is you can just, I'll copy this and this will adapt to my place. No, it's not gonna be like that.
Milenka Cuevas Guaman (08:11.281)
And then the other biggest thing, when we go to advocacy at the end, we kind of divide it. We divide it for advocacy for if you are a leader, these are the points that our leaders, in our case, we got together with chairman, we didn't write that, right? Like Kerry and I, we made it to associate, but we're not there yet. So we go with chairmen, the pediatrics, we go with deficiencies, we go with people that have gone through all of these, and we ask them to write this advocacy point.
leaders and we gave them kind of a structure the way we wrote it for advocacy for us for the day-to-day the anathology and when we say day-to-day the anathology it doesn't mean just I'm starting a new practice it just means hey how do I look to the schedule moving forward even if I'm going to stay in the same place and you need because I think one of the biggest thing is if we don't start at least if we don't start having this conversation nothing is going to change.
And even if that's all the toolkit is gonna give you, start the conversation, be open, you're probably accomplishing one of the most important things about all of these, which is being transparent.
Ben Courchia (09:25.036)
Yeah. Yeah. And I think that it kind of reminds me of the, feels like an anchor. It feels like this is where we're gonna lay our anchor and this is where the discussion is gonna start taking place. And I think that I wanna just compliment the work that you all did with your collaborators in not shying away from very practical, as you said, very practical issues that we all face in the unit. For example, people who go on...
on medical leave who are sick, like when they come back, do we expect payback? Do we expect making up this time? These are questions. I'm not going to say what the recommendation states because I want to invite people to go and check, but these are definitely questions that we all ask. How do we count the hours spent on call from home? It feels like, is it really clinical work? Is it not clinical work? I think all these are very practical consideration. And then you also...
Kerri Machut (09:59.731)
You
Ben Courchia (10:17.952)
separate this, like you said, with non-clinical considerations, and then you give very practical case studies. And like you said, I think that for many people, they might see this and they might this toolkit be hosted on the sections website and they might feel like, this is for like big academic centers. No, no, it's actually their case studies include, like you said, private practice, smaller units. And so there is...
principles that are valuable for every size, every type of groups. I think that, again, like you said, it is not meant to be the Bible from God. It's meant to be a starting point for the conversation saying, all right, this is the toolkit. Maybe you want to make it your own and make slight modifications that fit your group better. But at least you have an outline set of principles.
that are so helpful. so, Kerry, I would like to come back to you and ask you maybe for the people who are going to start looking at this, start having a conversation, what would you hope to hear back from them in terms of feedback and what do you expect the life of this work to continue to be?
Kerri Machut (11:35.751)
That's a great question. you know, we've been working on this toolkit for many months. I think we really started in the spring. It's almost a hundred pages of content. So took a while to get it all finalized and make sure it was rigorous and robust. It just went live about two weeks ago now on the AP section website. Again, it's on the main AP section website. It's not behind the paywall on the collaborative site so that everybody has access. Our first step was really trying to disseminate it to all our channels that we had before we put the
consensus recommendations out. So hopefully all the listeners saw it from some listserv through the AAP or through your institution. But the goal is really for every neonatologist to be aware of this. We are at NCE right now, actually in Denver, the AAP's main conference, and it's been featured at several talks throughout the weekend. It's getting a lot of buzz. And so the main thing is first that everybody at least knows that it's out there.
And like you suggested to go out there and really look and see maybe I'm sure there is one small element at the very least that's helpful and hopefully many more to any individual institution, center or individual physician themselves. So we would love to hear feedback on how people find this helpful to them that maybe it was, this was a great example of a night model in terms of we're trying to think about how we could do nocturnist coverage. Or maybe the advocacy section really gave me some
good ideas. I was nervous to talk to my boss or my leader about this and you know, asking for change around the leave scheduling and how to work through all that. So hopefully there are some things out there that people find helpful and then we hear back from people. We would love to and then from there really just kind of continue to promote the discussions. We know that there still would be a lot of work to get this into every center in the way that they want to but
We are happy to kind of help and facilitate those kinds of discussions. We gave a webinar earlier this summer on the recommendations themselves, but hopefully there'll be further talks and engagement about the toolkit itself.
Ben Courchia (13:39.916)
My favorite slide is slide 75, where you have the FTE allocation specifically for leadership roles, like how many FTEs should a fellowship program director offset? I think this is my favorite slide. I'm going to let people go check it out because you've answered the question.
Kerri Machut (13:54.02)
good. Well, it's funny during our talk yesterday, actually, at NCE, that was one of the audience members questions was, do you have any thoughts or recommendations around accounting CFTE for various leadership roles? And we're like, we do. We have a table. It's right there. So hopefully those are the exact kind of examples that people can find help.
Ben Courchia (14:08.503)
Yeah.
I absolutely love it.
Yeah, because I think it's cool because it's always the people with these defined roles probably feel like their offset should be higher and the people who don't have their role feel like the offset should be lower. And so it's nice that there is a table. And so yeah, I mean, if you've reviewed the toolkit, if you are implementing any parts of the toolkit with your division, you can share feedback to the team or share feedback through the incubator podcast and we'll relay it to the improving Neonatology staffing group.
and see if maybe what we can do to improve the toolkit in future edition, but it's already quite amazing. So, Kari, Melenka, thank you again for coming on the show and to talk to us about this, and congratulations on this amazing body of work.
Kerri Machut (15:00.722)
Thank you for having us.
Ben Courchia (26:51.47)
All right, we are back. Thank you to our guests for coming to share again their perspective and their incredible work. We are going straight back into Journal Club. And I have two more papers. What do you want to hear about, Daphna? I'm going to leave this one for last. I'll do this one. So there's a paper. No, I didn't let you pick.
Daphna Barbeau (26:58.808)
Hmm
Daphna Barbeau (27:10.978)
Help me.
Daphna Barbeau (27:14.646)
you decided you didn't let me pick. Okay.
Ben Courchia (27:19.874)
I'm going to go about a paper I saw in the Journal of Perinatology, and it's called, Comparison of Neurodevelopmental Outcome of Extremely Preterm Infants Undergoing Trans-Catheter Closure of the PDA Compared to Surgical Ligation. Yeah, it's exactly right. It's definitely a hot topic. This paper includes a lot of the people that you would expect to see.
Daphna Barbeau (27:28.344)
you
Daphna Barbeau (27:36.088)
Hot Topic.
Ben Courchia (27:50.036)
on this particular subject. Patrick McNamara is on it. Our friend Susan Hintz is on there. But the first author is Dinushan Kalawarichi, which we've spoke to before. So it's great to see familiar faces. And obviously, this is a topic that is very, very current. The reason is we know the prevalence of the PDA and that
surgical ligation was kind of the standard treatment when medical therapy failed. But in recent years, transcatheter closure has become quite common. In fact, between 2016 and 2021, the number of transcatheter closure procedures increased fourfolds. And by 2021, there were more than twice as many catheter-based closures as surgical ligations. So why does this matter?
prior study suggested that surgical ligation might be linked to worse long-term outcomes, including neurodemental impairment. However, those studies didn't often account for the co-founding factors like pre-ligation morbidities, the procedure itself, or the post-ligation syndrome that you can see after. At the same time, while early single-center reports hinted at transcatheter closure being safe and perhaps even superior, there's really not been large multi-center studies looking at
neurodevelopmental outcomes beyond the NICU. And that's the gap that this group aimed to fill. They asked the question whether extremely preterm infants among them, how do death and neurodevelopmental outcome at three years compare between the ones who underwent transcatheter closures versus surgical ligation? So this was a retrospective study, but using the NICHD Neonatal Research Network Database.
a retrospective cohort study of a rigorously collected set of data. The population included babies born between 22 weeks and zero days to 26 weeks and six days between 2016 and 2019. They excluded babies who were outborn, major congenital anomalies, and so on. The treatment definition, medical PDA treatment, meant that the baby received either endomethacin, ibuprofen, or Tylenol, or acetaminophen.
Ben Courchia (30:11.2)
And then the procedural PDA closure was either surgical ligation or transcatheter closure. The outcomes at 22 to 26 months included a standard neurological exam, a Bayley third edition. And the primary outcome was death or severe neurodevelopmental impairment. Severe NDI being defined as a Bayley 3 cognitive or motor score under 70, a gross motor impairment.
at the GMFCS level four or five bilateral blindness or deafness. They had secondary outcomes that included death alone, severe NDI alone, moderate to severe NDI, cerebral palsy, et cetera, et So let's look a little bit at the data. A total of 378 infants underwent PDA procedural closure. 99 infants had transcatheter closure. 279 had surgical ligation. And I suspect that as you do retrospective reviews of this data,
More and more, you will see that the number of babies undergoing surgical ligation is going to decrease in favor of babies undergoing transcatheter closure. And I think that the first thing that we should then pay attention to is the fact that the study was actually conducted between 2016 and 2019. It feels like, I mean, we're very old, but 2019 feels like it was yesterday, but it's not. It was six years ago and it's possible that these numbers might... I know.
Daphna Barbeau (31:30.368)
so long, six years.
Ben Courchia (31:32.194)
This is also, right, you have to remember that this is also a neurodevelopmental outcome study. So obviously the babies cannot be born yesterday and be evaluated at 26 months corrected. yeah, so mean, obviously that's the case, but it would be interesting to see how, if this study were to be repeated, how these numbers of babies who underwent the procedures has changed since, based on the data that they gave us in the introduction. Neurodevelopmental outcomes were available for 78 of the 99 infants in the transcatheter group.
Daphna Barbeau (31:36.696)
Hmm?
Ben Courchia (32:01.704)
and about 200 out of the 280 babies in the surgical ligation group. So the babies were born in both groups at similar gestational ages, 25 weeks versus 24.7 weeks, and the birth weights were similar, about 680 grams. What was interesting, Daphne, is that the median age at the procedure was much later for transcatheter closure, 62 days compared to only 32 days for surgical ligation. And the post-menstrual age at the intervention
was thus also later in the transcatheter closure, about 34 weeks compared to 29 weeks in the surgical ligation. Big difference. And again, I think this is going back to the point that I was trying to make earlier, which is that our interventional cardiologist colleagues are getting better and better at doing these transcatheter closure in smaller and smaller infants, which might hint at the fact that today these numbers might actually look a little bit different. Another important difference between the two is that
Daphna Barbeau (32:38.242)
Big difference.
Daphna Barbeau (32:49.666)
Mm-hmm.
Daphna Barbeau (32:56.866)
right?
Ben Courchia (33:00.142)
periventricular leukomalacia, PVL, was more common in the transcatheter closure group, 16 % compared to 8%. This will obviously be something that they will have to account for in the analysis as they're trying to look at long-term outcomes because of this sort of baseline difference.
Daphna Barbeau (33:19.714)
Well, and that's interesting, right? Because of the data that shows that it's, I mean, exposure to a PDA itself, it changes outcomes, the length of exposure.
Ben Courchia (33:26.498)
Mm-hmm.
Ben Courchia (33:30.741)
Yeah. In terms of the primary outcome of death or severe NDI, well, there was no difference between the two groups. It occurred in 49 % of the transcatheter closure group versus 40 % of the surgically ligated infants. Again, not statistically significant. Looking at death before follow-up, also not very different. 3 % in the transcatheter group, 6 % in the surgical group, not significant. And then in terms of
Severe NDI among survivors, severe NDI alone, this was higher in the transcatheter closure group, 47 % versus 34%. In the adjusted analysis, after adjustment, there was no difference in the odds of death or severe NDI between the two groups and no difference in death alone or severe NDI alone. You can see again that this PVR situation might have been sort of washed out and no longer significant. So I don't know what you think.
I think this is good. That means that we don't really need to move back to a case of surgical ligation. We can probably continue with transcatheter closure. But I was kind of hoping transcatheter closure might have better outcomes. So.
Daphna Barbeau (34:37.042)
Yeah. Well, I mean, again, I think had it shown that surgical was better, you'd say, was it because they didn't have this long exposure to the PDA? But that's not what we found. So I actually think it's really exciting data. Yeah, I'm encouraged by this. That's exactly right. Yeah. And I wonder, as you said, we're going to get all this information about babies who are now getting transcatheter closure earlier.
Ben Courchia (34:48.163)
Yeah.
Ben Courchia (34:52.728)
You're encouraged. You're encouraged by this. That's great. I think that you're making a good point.
Daphna Barbeau (35:06.474)
So then maybe there will be more information.
Ben Courchia (35:08.096)
And I think that for us, for example, we can give people our personal experience with all this is that we are a center that does not conduct cardiac surgeries, but we are having the opportunity to implement transcatheter closure of the PDA with an association with a larger sort of cardiac center. And so, yeah, I mean, you're right. It also will become available probably to more centers, and then we'll see what the outcomes are.
Daphna Barbeau (35:18.072)
Mm-hmm.
Ben Courchia (35:36.972)
The conclusion of the authors is that this data provides the first large multi-site comparison between transcatheter closure and surgical ligation on two-year follow-up outcomes. And as the age of transcatheter closure declines, our findings should be reevaluated in prospective studies that include infants receiving non-procedural treatment of the PDA as the comparison group and with better assessment of the magnitude and duration of pediatrician physiology and related hemorrhage.
Daphna Barbeau (35:53.688)
Mm-hmm.
Ben Courchia (36:07.31)
So they're very well aware of all the things that we mentioned. So yeah, very, very neat.
Daphna Barbeau (36:12.523)
The PDA discussion persists. No pun intended. Okay. Did you want, you said you had two, did you want to do yours or you want me to do one? Okay. gosh. okay, fine. Okay, I also had two more, but one again is quite short. There was this paper that you actually had highlighted, parent and practitioner experiences of op.
Ben Courchia (36:15.852)
Yeah, yeah, yeah.
Ben Courchia (36:23.372)
Yeah, the last one is very tiny, it's sort of a kick in the gut. So I'll save it for last.
Daphna Barbeau (36:41.193)
out consent in neonatal intensive care, a mixed method study within a trial. So basically, sorry, this is coming to us. It's in the archives of disease and childhood, and this is coming from the UK. So basically, they had the neogastric trial. It's a randomized control trial looking at routine and measurement of residuals versus not measuring residuals, which
has been looked at. Anyways, it's a large study and they were trying to, it's about residuals. So what they did for this study was they were trying to evaluate what they were kind of already doing, which was using opt out consent. So they wanted to specifically look at how did parents and staff feel about the use of opt out consent. So what is opt out consent?
Ben Courchia (37:13.006)
It's not me, it's about residuals.
Daphna Barbeau (37:39.8)
Typically, you know, we really struggle. All of the researchers who have come on have said how difficult it is sometimes to enroll patients into neonatal studies. And there are many factors, a lot of which will be discussed here, especially about this is such a stressful time. When do we approach families about getting involved in research? What sorts of topics?
Can we ask parents about early on? So there's a lot of complication, especially in our community and population of babies. So basically they wanted to look at their group, the criteria for kind of enrollment, parent and guardians were required to...
speak English, so no difficulty understanding the survey or the focus group in English. The gestational age at birth was less than 34 weeks, and the babies had to have had an NG or an OG tube in place. And I believe they were enrolling families until babies reached like 15 mLs per kilo of feeds. So they really didn't have a lot of time to do that. that is part of...
one of the aspects that was discussed in the parent and staff reports and they talked about in the discussion. So basically the staff assessed the eligibility and provided parents with kind of the neogastric process study information. so basically they were theoretically randomized, but parents could opt out of engaging in the study. And then for this,
study. Parents were invited then to complete a questionnaire before leaving the hospital and or to register interest in participating in an interview with one of their researchers kind of a few weeks after discharge about this enrollment process. They also wanted to interview staff, so they asked staff to complete either online or paper questionnaire at the end of their first shift caring for this particular baby.
Daphna Barbeau (39:55.906)
where a parent was also enrolled. Okay, they arranged interviews then via video conference or telephone as per parent preference. And then they also, after those interviews, also allowed for these online focus groups, kind of four to six months after recruitment. They were looking to get 80 parent questionnaires and...
80 parent and staff questionnaires. They wanted to hit at least 20 babies per site. So in total, they had 85 parents, 59 mothers, 26 fathers complete a questionnaire of this group. They looked back at who had opted out. They had an 8 % opt out rate in that group. And this is consistent with the overall neogastric trial. I think they had 7, yeah, 7.4 % opt out rate overall, which I thought was pretty
pretty good. So in general, vast majority, 92 % of participants, both in this cohort and the overall group, decided to stay in the study. Okay. They interviewed 15 parents, 12 fathers and three mothers, either online, there's 12, or by telephone, there's three. And in this group, none had opted their baby out of the trial.
They also did a total of 149 staff questionnaires linked to 96 babies across four sites. So one of the things that was noted was variability in how the verbal opt-out process was taken. So there was not a specified time at which they were going to approach parents, except, like I said, they were trying to do this in really the first few days of life.
And this created scenarios where some moms were approached either during labor or right after delivery. they said, a quote, when lying on your back with your legs akimbo or while waiting for a cesarean, most of the parents were approached within hours or days of birth. And interestingly, one mother had no recollection of the timing of approach at all.
Daphna Barbeau (42:19.273)
Interestingly, parents who did not recall a discussion were not concerned about their child being entered into the trial without a discussion. And one father described how he had seen the research poster and he presumed the child would be involved. So they did have posters across the study sites, which indicated what the study was about, that parents would be approached in this manner.
And they even highlighted that the study banners were very large, greater than 180 centimeters. For our US colleagues, that's 70 inches. And they felt like they put them in prominent positions throughout the units. So this dad had seen that ahead of time. And they'll talk a little bit about that as well. So then there was a lot of concern about approaching parents too early.
So 82 % of parents felt that they were approached about the study at a convenient time. However, the interviews and the staff questionnaires indicated that parents approached during labor or shortly after birth were really surprised at being asked to consider research and just make some sort of decision about their child's involvement during this really kind of chaotic time.
Parents described feeling overwhelmed with information about their baby's condition. They felt they lacked the capacity to consider research at that time. And some questioned whether it was even like appropriate to be asked, especially if their baby was critically ill. A quote said, I thought it'd be more of a priority to make sure my baby was like sort of stable before they asked me about research.
the staff also felt the same way. They described having to approach moms early again, because trying to get it before this feeding volume, but that it was, the timing was not totally appropriate. they thought it was, that parents didn't have the time to concentrate on what they were being told. They didn't have the, the ability to digest the trial information.
Daphna Barbeau (44:26.665)
And parents who felt that they were approached at a convenient time, so most of these parents are now days from birth rather than hours from birth, appeared to have better recall the discussion and they felt the timing was more appropriate when they were quote, a little bit more with it. Another quote, by speaking to us on day three, it meant I could kind of understand and support the study. And this came across a lot in the nurses,
Ben Courchia (44:42.51)
you
Daphna Barbeau (44:55.991)
quotes said that when we approached the parents too early, parents initially opted out because they felt totally overwhelmed. But once they had more time and it was explained more clearly, some parents actually opted in later because they felt they were approached at a better time. So that was very interesting. There were some other things that I wanted to highlight. There was some confusion because we were asking parents about opting out that were they really opting out because they were
kind of being asked whether they wanted to be in or out. But again, this was different than kind of formal informed consent. So that was a little interesting, both some confusion on the family side and the staff side. Okay, one more thing I wanted to say. Even parents who describe the burden of being approached too early,
Ben Courchia (45:33.581)
Mmm.
Daphna Barbeau (45:54.26)
stated that they did not opt their baby out for the most part due to the perceived low risk nature of the study and this opportunity to help others in the future. I think the point of evaluating this was it also depends on the study. So for things that are potentially perceived as low risk, maybe this is a totally acceptable way to do it, but for things that required a little bit more thinking, higher risk,
that maybe we needed to take a different type of approach. And finally, the reasons for opting out, parents who did opt out their baby stated they usually did so because they were uncertain about the intervention, they didn't understand the impact on their child or specifically how their data was gonna be used, but none of them raised concerns about full informed consent not being sought. And the staff data confirmed this, they thought that although the minority reported patients had opted out,
mostly because they were approached too early. And the other thing I wanted to say is, I told you a little bit about these banners. They really had a goal of informing parents about the study, again, before even being asked to opt in or out. I told you the banners were very big. They were placed in very prominent positions, but only 21 % of the parents even reported seeing the poster of the banner.
even having thought about the study before being approached despite the team's best efforts. So I think this is interesting. A lot of people are talking about opt-in consent. Major research institutions are having families sign a blanket consent form saying that their babies are likely to be enrolled in research and that then they have the opportunity to opt out. But it was nice to see a study looking at how do parents actually feel about it.
Ben Courchia (47:49.612)
Yeah, I I couldn't help but just think about the state of affairs in the US where I think there's a lot of mistrust in the system at this point. It's going to be harder than ever. And it's interesting because I feel like since I started my fellowship in hemodynamics in Montreal, like I see, for example, in Canada that it seems much easier to actually get people to buy into
Daphna Barbeau (48:00.023)
Mm-hmm. I think it's gonna be harder than ever to be doing.
Ben Courchia (48:16.728)
these research projects, people feel like, I want to help if this can help other babies. We see this frequently actually during the hemodynamic stuff when we do research echoes. Parents are like, yeah, if this helps other babies, then go ahead. yeah, I just hope that we can keep research efforts going. Otherwise, no more Journal Club. Yeah.
Daphna Barbeau (48:42.197)
I know, what are we gonna do with our time?
Ben Courchia (48:46.99)
Okay. Yeah, I have one more and then that's going to be it for me today. But it's a very brief article that I found in pediatrics and it's called Critical Congenital Heart Disease and Infant Cancer. So the introduction is interesting. It mentions how congenital heart defects affect about 1 % of all births in the US.
Daphna Barbeau (48:47.159)
Okay, we each have one more, so we gotta hustle here.
Ben Courchia (49:11.36)
And about 20 % of these are classified as critical congenital heart disease. So we're not talking about like a very small PFO. These defects impact blood flow in and out and through the heart and require intervention early in life. And there has been some studies that have apparently made this link between critical congenital heart disease and cancer. But literature is very limited. And one of the points the authors are making is that it's very clouded by the diagnosis of trisomy 21. And so the question they're asking is that are infants with isolated CCHD or
Daphna Barbeau (49:38.634)
Interesting.
Ben Courchia (49:40.896)
also are at increased risk of cancer, and if so, which cancer are involved? And so they looked out estimating the risk of cancer in the first year of life for infants born with CCHD using a large California birth cohort. So they used these data sets from the study of mothers and infants, a population-based administrative cohort in California that links the vital statistics files with hospital discharge records. So this is a database review.
And it includes all singleton pregnancy between 2007 and 2020. Now the exposure of interest is a diagnosis of CCHD using the ICD-10 codes. And then the outcome of interest is any cancer within the first year of life, specifically leukemia, CNS tumors, rhabdomyo-sarcoma, hepatoblastoma, retinoblastoma, Wilms tumor, or lymphoma.
They did a lot of interesting statistics, but they also had an interesting statistic approach to actually both include the trisomy 21 patients and then excluding them as well, just because of the very strong association between trisomy 21 and malignancy down the road, just to see if maybe they were the primary driver of this particular association. So from more than six million births in California,
The researchers identified 24,213 cases of CCHD, which equates to about a prevalence of 398 per 100,000 live births. Infants with CCHD were more likely to be born prematurely. They were more likely to have trisomy 21 or other genetic syndromes. And they were more likely to be born to mothers who had diabetes, hypertension, or some form of infection during the pregnancy. Now let's look at the main...
the main outcome, which is the different cancer outcomes. any cancer in the first year of life occurred at a rate of 1,107 per 100,000 infants with CCHD compared to only 94 per 100,000 in babies without CCHD. That's a risk ratio of 12. When do you see a risk ratio of 12 with a confidence interval between 10 and 13? Now, what they did is that they said, OK, let's remove
Ben Courchia (52:01.582)
basically with trisomy 21 or other syndrome. And they show that while the data is slightly attenuated, it remains elevated. Frightening. at specific malignancies, leukemia, the risk ratio is 14.9, CNS tumors 5.7, rhabdomyo-sarcoma 14.1, hepatoblastoma 12.2.
And the other ones, retinoblastoma, Williams lymphocytosis, they were not evaluated because there were too few cases to actually make a significant sort of description of these outcomes. What else can I tell you?
Ben Courchia (52:54.266)
And again, I would suggest people look at this paper and look at table two, because it looks at basically the risk estimates for CCHD and cancers. And this is quite nice, because you have the prevalence with CCHD, without CCHD. And then you have the risk ratios with trisomy 21 excluded, with trisomy 21 and other congenital syndrome excluded. So you can actually do your comparison.
The conclusion is that there is no conclusion. It highlights an importance of maybe monitoring these infants more closely. And the authors really can't make a good, can't give us a good rationale for why would this be happening. They venture to say that it's a complex interplay of genetic and epigenetic and environmental factors that may influence the risk, which is basically fancy way of saying we really don't know. And again,
Daphna Barbeau (53:38.493)
Mm-hmm.
Daphna Barbeau (53:42.614)
Thank you.
Daphna Barbeau (53:48.822)
I
Ben Courchia (53:50.618)
There's nothing wrong with that. I think it's now our job to explore this potential association. But I feel so bad for the families who have babies with CCHD because you get the cardiac lesions taken care of and you hope you're out of the woods. But it seems like there's one more thing to keep an eye out for.
Daphna Barbeau (53:54.324)
Mm-hmm.
Daphna Barbeau (54:11.338)
Terrifying. Wow. Okay. Well, I'm glad they didn't find a definitive link, but...
Ben Courchia (54:17.41)
That's why I didn't want to mention this too much because I was like, it's going to bum out everybody throughout the show.
Daphna Barbeau (54:24.488)
It's a bummer. Well, I have another quickie. This is in pediatrics. It's entitled Screening for Autism and Preterm Children, a systematic review. Obviously autism is a hot topic. getting more and more talked about, especially in the last few weeks.
Ben Courchia (54:31.725)
Yeah.
Daphna Barbeau (54:48.95)
But basically what they wanted to do is really, sorry, this is coming out of Canada. They wanted to do a meta-analysis to evaluate the validated autism screening tools for use in the preterm population. And they were interested in this because the overall rate prevalence of autism in children born at term is about 3%.
but this increases to a rate of about 7 % in children born preterm. So that's something they wanted to look at. To make things more complicated, they really highlighted that a lot of the studies that validated the autism screening tools early on, tools that we're using all the time, have frequently excluded premature infants or haven't corrected for gestational age so that...
And even though the AAP does recommend screening for all children at ages 18 and 24 months, that maybe the tools we're using aren't appropriate for the premature infant. They also really wanted to underscore that there are some things that they call the premature phenotype that may overlap with an autism diagnosis. So things like...
sensitivity, sensory sensitivity, things like that, that may be part of the autism diagnosis that is often seen in the preterm population. And that maybe we need to take another closer look at these babies. So the children needed to have a clinical diagnosis of autism as their kind of reference standard in the review. And then...
Again, this was looked at compared to some of the screening tools. So they used nine studies in this review. And the most common screeners were the number one one was the M-CHAT, the Modified Checklist for Autism in Toddlers. It's a 20 question parent survey. And it's supposed to assess toddlers at 16 to 30 months.
Daphna Barbeau (57:06.25)
The second most used survey was the social communication questionnaire, the SCQ. It's a 40-question parent survey intended for children over the age of four. So the concern about that one is, you know, for screening kids, we recommended to screen kids at 18 to 24 months. This one's really for children over the age of four. And then they looked at what were the sensitivity and specificity in the preterm population. And actually they showed that
there were multiple other tools reviewed. So the like things like the Bailey scales and they did not meet the generally agreed upon minimum threshold of 70 % for sensitivity and specificity for developmental behavioral screening for this group looking specifically at autism. So the only two that even met that criteria for use were the M-Chat and the SCQ and the M-Chat showed a sensitivity of 50.
5 % and a specificity of 85%. So they was able to be used and the SEQ was 53 % sensitive, 90 % specific in the preterm population. So their take-home points were basically that the current screening tools for autism in the preterm population really have low sensitivity and only moderate specificity. So their kind of take-home point is that
these screening tools should really not be the sole means of identifying autism risk in this population. They recommended repeat screening. So screening first at 18 months and again at 24 months in the preterm population. And importantly, then doing really interactive or observational screening. So what that means is having a professional interact and engage with the child, not just using the parent.
survey responses. And really, the other take home point was that perhaps we need an independent screening tool for preterm infants and autism, especially given the overlapping of symptoms. So again, if somebody's looking for a career-defining area of focus, this would be another place to look. That's right. You're welcome.
Ben Courchia (59:23.374)
Yeah, this was the career advice journal club. Yeah, I mean, I think this is a very interesting paper. And I think to me, it comes back to a lot. It comes back to a lot of the things that we discussed, especially as autism is in the news thanks to the current US government, because it just highlights how little we understand of this pathology.
Daphna Barbeau (59:37.43)
Mmm.
Ben Courchia (59:49.098)
Same thing with whatever recommendations were discussed by the administration, but just this idea that the sensitivity of the screening tool ranges from zero to 100. So define chance for me, and that's it. We really don't. And it's not a knock. And then the recommendation is the most primitive way of correcting for that, which is just do serial measurements and then hope that like you're flipping a coin that eventually you're
Daphna Barbeau (59:58.699)
Yeah, that's right. That's right. Yeah.
Daphna Barbeau (01:00:12.96)
Hmm. Something will flag.
Ben Courchia (01:00:16.206)
No, that eventually you'll get to whatever the outcome you're supposed to get to should be. And again, how, I mean, I'm just, it's, what's fascinating to me is that our civilization is smart. We figured out so many things and how can we, like so much, so many resources have been poured at autism research. And yet we're still frustrated by this pathology. How crazy is that, that we are
Daphna Barbeau (01:00:38.006)
you
Ben Courchia (01:00:45.646)
We're nowhere closer and that's kind of disappointing, frustrating, depressing, but I don't think it should moderate the efforts. I think we should just keep going, man.
Daphna Barbeau (01:01:01.398)
Yeah, it's a complicated time. did think it was really interesting. When we talk about though, how the incidence is increasing and obviously there are a number of rationales for that, but I didn't recognize how prematurity might play a role in that. Our ability to save premature babies younger and younger, more and more at risk and in higher and higher numbers probably does contribute to this somewhat. I, you know, I hadn't thought about that previously. So of those.
Ben Courchia (01:01:30.38)
And we've reviewed papers that showed that primaturity is a risk factor in and of itself. But again, yeah, we still have to figure out how to diagnose. Diagnosis is the problem. Can you imagine?
Daphna Barbeau (01:01:31.754)
Yeah, for sure.
Daphna Barbeau (01:01:40.97)
That's true. Yeah.
Yeah, I think again, it's a clinical diagnosis. There are some exciting studies about some biochemical diagnoses. mean, I think that will revolutionize things if there's a biochemical marker.
Ben Courchia (01:02:02.38)
Let's see. I'm really hoping. I'm really hoping because this would be phenomenal. Anyway, I think that does it for Journal Club for today. Thank you to everybody for if you're listening to the Journal Club, we're breaking the episodes in shorts. But if you are listening on the main episode and you've made it this far, you're a true fan. We really appreciate it.
Daphna Barbeau (01:02:23.542)
Thanks for sticking with us. That's true.
Ben Courchia (01:02:26.338)
We should have giveaways for the people who are specifically, just for this particular episode. We give people a coupon code or something like that. But we'll think about that. Yeah, we will think about something like that to reward the people who stick to the end. Daphne, thank you so much. I'll see you next time for more great Unitology content.
Daphna Barbeau (01:02:33.27)
I like that. Can we do that? Okay.
Daphna Barbeau (01:02:45.783)
Bye everybody.