Tag Archives: Randomized Controlled Trials

Is it a duck? Is it a mole? Platipus and Trial Design Innovations.

When the platypus was first captured, killed, skinned and the pelt sent to a zoologist in London, George Shaw in 1799, he thought he was being scammed. He tried to find the stitches that had been used to cobble together … Continue reading

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A lower limit for restrictive transfusion strategies? Not directly neonatology…

Several trials of liberal versus more restrictive transfusion practices have been published, and overall, it seems that being very restrictive in transfusions has no negative impacts on clinical outcomes, and depending on the trial, some positive benefits of avoiding transfusion. … Continue reading

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Bilirubin is Bad for the Brain! Who knew?

We have known for a very long time that bilirubin can cause an encephalopathy leading to acute and chronic clinical impacts, the most severe chronic impacts being kernicterus, a disabling movement disorder and nerve deafness. What seems to be the … Continue reading

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Breast is Best; is Fresher Better?

A recurrent problem in the NICU is “bandwagon-jumping”. An intervention with some preliminary positive data, and a possible physiologic rationale is widely adopted and made part of QI bundles with little or no reliable evidence that it is either effective … Continue reading

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Surfactant plus Budesonide? Not a PLUSS for outcomes

Many of us were already aware of the general direction of the results of this trial, a multi-centre RCT of surfactant with or without budesonide (Manley BJ, et al. Intratracheal Budesonide Mixed With Surfactant for Extremely Preterm Infants. JAMA. 2024), … Continue reading

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Surgery for NEC; enterostomy or anastomosis?

There are only a few randomized trials in neonatal surgery, but those that exist have had a major impact. This new publication may do the same, even though the sample size is relatively modest, and there are some issues with … Continue reading

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Making Clinical Research Oversight Fit-for-Purpose

The title is a slightly edited copy of the title a discussion article in JAMA, that discusses some important issues in IRB oversight of clinical research. (Kass NE, et al. Making the Ethical Oversight of All Clinical Trials Fit for … Continue reading

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Badly performed, badly presented, unethical published research; what to do?

Since at least 2013 the World Medical Association Declaration of Helsinki has mandated registration of clinical trials prior to enrolment of the first subject. Since 2005 the International Committee of Medical Journal Editors has required trial registration as a condition … Continue reading

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Sending home preterm babies with Inguinal Hernias

It has been dogma for quite some time that newborn preterm infants with Inguinal Hernias (I will resist the temptation to latinise the plural, although I was brought up hearing about ‘herniae’) should have them surgically fixed prior to discharge … Continue reading

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Colostrum and feeding preterm babies

Forgive me if you are already convinced, but I remain somewhat sceptical of the benefits of routinely painting the inside of the preterm infant’s mouth with colostrum. Even though I have supported the introduction of the practice on our NICU, … Continue reading

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