Tag Archives: Randomized Controlled Trials

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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What happened to the HeROs?

I had to find a way of changing HeRO to Heroes as an excuse for posting a link to this video But also the results of a long term follow up of the HeRO trial have been published. The original … Continue reading

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Breast milk fortifiers, a new systematic review

A systematic review has just been published which compares the outcomes of milk fortification with bovine-milk derived fortifier and human-milk derived fortifier. (Grace E, et al. Safety and efficacy of human milk-based fortifier in enterally fed preterm and/or low birthweight … Continue reading

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Evidence-Based Neonatology: more and more evidence, better and better care

For another project, which I will explain later, I have been trying to find recent large multicentre trials in very preterm babies. I searched PubMed for “Randomized Controlled Trial’, and “Multicentre study”, then filtered by Human and Newborn and Preterm … Continue reading

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