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Barriers to enrollment in a randomized controlled trial of hydrocortisone for cardiovascular insufficiency in term and late preterm newborn infants

Journal of Perinatology Sep 20, 2017

Watterberg KL, et al. - The reasons for low enrollment were gauged here, in a randomized controlled trial (RCT) of the effect of hydrocortisone for cardiovascular insufficiency on survival without neurodevelopmental impairment (NDI), among term/late preterm newborns. Irrespective of the observational study estimating the population, very few infants were enrolled. Successful RCTs of emergent therapy could warrant fewer exclusions, a short-term primary outcome, waiver of consent and/or other alternatives.
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