Barriers to enrollment in a randomized controlled trial of hydrocortisone for cardiovascular insufficiency in term and late preterm newborn infants.
K L WatterbergE FernandezM C WalshW E TruogB J StollG M SokolK A KennedyM V FragaS S BeaumanBenjamin A CarperA DasA F DuncanW F BussC GauldinC B LacyP J SanchezS ChawlaS LakshminrusimhaC M CottenK P Van MeursB B PoindexterE F BellW A CarloU DevaskarM H WyckoffR D HigginsPublished in: Journal of perinatology : official journal of the California Perinatal Association (2017)
Despite an observational study to estimate the population, very few infants were enrolled. Successful RCTs of emergent therapy may require fewer exclusions, a short-term primary outcome, waiver of consent and/or other alternatives.