Tag Archives: Randomized Controlled Trials

Neonatal Updates

It’s a long time since I did one of these, but there were several publications that I thought warranted a quick comment. Abbey NV, et al. Electrocardiogram for heart rate evaluation during preterm resuscitation at birth: a randomized trial. Pediatr … Continue reading

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Delivering better CPAP in the delivery room, can we avoid intubation in the most immature babies?

Randomized trials have shown that trying to prevent intubation in the DR leads to less severe lung injury. The Cochrane review of prophylactic CPAP compared to immediate intubation included 3 trials (SUPPORT, COIN and DR Management study), that review found … Continue reading

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Intestinal perforation in the very preterm, what causes it, and what to do about it.

There are 2 main causes of intestinal perforation in the very preterm, Necrotising Enterocolitis and Spontaneous Perforation. NEC, as I have previously discussed, may be a convenient name for a few different conditions which present in a similar fashion. In … Continue reading

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Opioid infusions for ventilated preterm babies

Many practices in neonatology are variable between NICUs, and many vary from year to year; without any good scientific data practices become fashionable or routine or ingrained without necessarily having an evidence base to support them. One such practice is … Continue reading

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Pain studies with untreated control groups in babies are unethical.

If you are performing a study of pain control in the newborn and you assign babies to untreated controls, you are creating unnecessary avoidable pain in the control patients. That is true for any patient who is incompetent, obviously including … Continue reading

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Plug the Lung Until it Grows: the FETO RCTs of antenatal diaphragmatic hernia intervention.

What was at one time called PLUG, and, with the change from open to endoscopic intervention, is now called FETO (fetal endoscopic tracheal occlusion) is a way to harness the normal physiology of the lung in congential diaphragmatic hernia (CDH) … Continue reading

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Which is worse; death or a low Bayley score? Comparing composite outcomes between groups, taking into account clinical priorities.

I keep harping on about this issue as I think we make a mistake in the design of our research studies when we include death and a much less important outcome in composite outcomes. For example in the STOP-BPD trial, … Continue reading

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Longer term outcomes; what should we measure? part 1.

Many important trials include follow-up to about 2 years in order to ascertain longer-term effects. Such as this one: Adams-Chapman I, et al. Neurodevelopmental outcome of preterm infants enrolled in myo-inositol randomized controlled trial. J Perinatol. 2021. Ira Adams-Chapman was … Continue reading

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When should we transfuse preterm babies, and why? Redux.

The TOP trial has just been published in the FPNEJM (Kirpalani H, et al. Higher or Lower Hemoglobin Transfusion Thresholds for Preterm Infants. N Engl J Med. 2020;383(27):2639-51). It was a multicenter, non-masked RCT among 1800 babies of less than … Continue reading

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Diuretics as Anticonvulsants?

In recent years there has been a lot of interest in neonatal seizures and how to treat them. Older studies confirmed that phenobarbitone (or phenobarbital, I never know these days) appears effective, but with limits; many babies have a partial … Continue reading

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