Oct 25, 2026 · 30 min · 10 segments
Send us Fan Mail Daphna and Christa sit down with Dr. Alfonso Vargas to preview his journal club. They review the NICHD Neonatal Research Network…
Alfonso VargasGuestChristaHostDaphna Yasova BarbeauHost
But the first article we're going to cover was the NICHD, like the NRN PDA expectant management RCT that was published this year.

Basically looking at whether or not expectant management, and this is just a subset of babies.

So this... randomized trial really sought to try and answer that question, at least for this subset of babies, for these subset of high-risk babies.

So they were supposed to recruit 800 babies, I think, for it to be powered enough to answer their primary outcome, which was death or BPD at 36 weeks.

Yet they had to halt it, I think, at about 480 patients that were recruited because of a safety concern.

They were starting to see trends where the mortality in the treatment group was higher, I mean, to the tune of like more than double.

And yet, as far as the primary outcome of death or BPD, they were really seeing no difference.

And so there was only about a 2% chance that if they finished the trial, recruited all 800 patients, there's only about a 2% chance that they would have actually found a difference there.

So But what really kind of got my attention was more the safety concern because our mantra when we start practicing medicine is first do no harm.

So if you're telling me something I'm doing routinely is potentially causing harm, you really have to put the brakes on and say, okay, we need to reevaluate our process.

What was also interesting about that study is there were thousands of babies that were eligible but weren't randomized.

So that tells us that by and large, what we are doing in our hospitals nowadays across the country is treating PDAs in these very small, fragile infants.

And this study points out, the trial did conclude that there is a significant mortality risk for those babies.

But the first article we're going to cover was the NICHD, like the NRN PDA expectant management RCT that was published this year.

Basically looking at whether or not expectant management, and this is just a subset of babies.

So this... randomized trial really sought to try and answer that question, at least for this subset of babies, for these subset of high-risk babies.

So they were supposed to recruit 800 babies, I think, for it to be powered enough to answer their primary outcome, which was death or BPD at 36 weeks.

Yet they had to halt it, I think, at about 480 patients that were recruited because of a safety concern.

They were starting to see trends where the mortality in the treatment group was higher, I mean, to the tune of like more than double.

And yet, as far as the primary outcome of death or BPD, they were really seeing no difference.

And so there was only about a 2% chance that if they finished the trial, recruited all 800 patients, there's only about a 2% chance that they would have actually found a difference there.

So But what really kind of got my attention was more the safety concern because our mantra when we start practicing medicine is first do no harm.

So if you're telling me something I'm doing routinely is potentially causing harm, you really have to put the brakes on and say, okay, we need to reevaluate our process.

What was also interesting about that study is there were thousands of babies that were eligible but weren't randomized.

So that tells us that by and large, what we are doing in our hospitals nowadays across the country is treating PDAs in these very small, fragile infants.

And this study points out, the trial did conclude that there is a significant mortality risk for those babies.
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