Tag Archives: Randomized Controlled Trials

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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Three trials with null results, how should we respond?

These 3 articles have just been published, all show no difference in long term outcomes between the randomized groups. What does that mean for the impact on therapeutic decision-making? Natalucci G, et al. Neurodevelopmental Outcomes at Age 5 Years After … Continue reading

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What role for High Flow Nasal Cannulae?

There are a few new publications which might help us to answer the question posed in the title of this post. When heated, humidified, high flow nasal cannulae were first being spoken about I remembered an old study using standard … Continue reading

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Probiotics and NEC, the latest answer?

The updated Cochrane review of probiotics for prevention of NEC, sepsis and mortality has been published. Meta-analysis showed that probiotics may reduce the risk of NEC: RR 0.54, 95% CI 0.45 to 0.65 (54 trials, 10,604 infants; I2 = 17%); … Continue reading

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