Tag Archives: Randomized Controlled Trials

Unethical pain research in the newborn. A list of shame.

Unethical pain studies are still being published, in journals which include several from mainstream publishing houses. In these studies published recently and appearing on-line in recent weeks, newborn infants were assigned by the researchers to experience pain. The reviewers of … Continue reading

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Should we treat electrographic seizures?

In order to answer the question posed in the title you would need to take babies at risk of seizures, but not yet having clinically diagnosed convulsions, randomize them to have routine continuous EEG monitoring or not and then treat … Continue reading

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Was OPTIMIST too optimistic?

One of the trials we have been waiting for has just been published Dargaville PA, et al. Effect of Minimally Invasive Surfactant Therapy vs Sham Treatment on Death or Bronchopulmonary Dysplasia in Preterm Infants With Respiratory Distress Syndrome: The OPTIMIST-A … Continue reading

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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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