Tag Archives: Research Design

Two New Publications

After a few weeks break (for a number of reasons), I’m ready to start blogging again! I’m sure you have all missed the succinct and perceptive critiques of the recent neonatal literature, but today I will start with 2 publications … Continue reading

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The best outcome variable for very preterm newborns?

Death or ‘neurodevelopmental impairment’ (NDI) as a combined outcome has become a sort of de facto standard as the primary outcome for neonatal clinical trials. Because many very preterm infants have developmental delay, intellectual and learning difficulties, and some have … Continue reading

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Conflicts of interest are not all financial, but they are conflicts none the less. Name change not required.

Another poorly argued article trying to minimize the reality of conflicts of interest in medical research. Cappola AR, FitzGerald GA. Confluence, not conflict of interest: Name change necessary. JAMA. 2015;314(17):1791-2. If someone stands to have a personal advantage as a result … Continue reading

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Late Surfactant may not be effective, probably.

A large multi-center trial (n=511) led by Roberta Ballard has just been published. (Ballard RA, et al. Randomized Trial of Late Surfactant Treatment in Ventilated Preterm Infants Receiving Inhaled Nitric Oxide. J Pediatr 2015.) In this trial infants had similar … Continue reading

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Murky Guidance

After the OHRP meetings and their evaluation of the SUPPORT controversy, the OHRP have now released what they call “Draft Guidance on Disclosing Reasonably Foreseeable Risks in Research Evaluating Standards of Care” The conclusion of the draft guidance starts with … Continue reading

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What do parents of twins (and the twins) think about randomizing multiples

There has been some controversy recently about how we should randomize twins (and triplets or more) in neonatal trials. The question being whether randomizing the babies independently or randomizing them as a group is preferable. Those who wish to randomize … Continue reading

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Appropriate outcomes for neonatal research

Neil Marlow has published a thoughtful, and thought provoking, article to address the issue outlined in the title. What are the appropriate outcomes when designing neonatal research studies? It has become almost a rule, that a multi-center trial of an … Continue reading

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Oxygen, transfusions, and NEC

What causes NEC! The answer is ‘who knows?’, or perhaps a better one would be ‘its complicated…’ You probably need an immature gut, gut mucosal injury, inflammation and cytokine release, and an abnormal microbiome, all of which probably interact in … Continue reading

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Public citizen are becoming a public danger

Public citizen are at it again, they have written another letter to the director of the DHHSS to try and follow up on their previous nonsense. I didn’t write about this when I first heard about it, as 1. it … Continue reading

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HIP Protocol published

The Hypotension in Preterms trial is about to get underway, with all the final hurdles just about cleared. Just at the right time our protocol has been published in ‘Neonatology’. Dempsey EM, Barrington KJ, Marlow N, O’Donnell CP, Miletin J, … Continue reading

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