title: Neurodevelopmental Outcomes of Extremely Preterm Infants Randomized to Stress Dose Hydrocortisone.
abstract: OBJECTIVE
  To compare the effects of stress dose hydrocortisone therapy with placebo on survival without neurodevelopmental impairments in high-risk preterm infants.
  
  
  METHODS
  We recruited 64 extremely low birth weight (birth weight ≤1000 g) infants between the ages of 10 and 21 postnatal days who were ventilator-dependent and at high-risk for bronchopulmonary dysplasia. Infants were randomized to a tapering 7-day course of stress dose hydrocortisone or saline placebo. The primary outcome at follow-up was a composite of death, cognitive or language delay, cerebral palsy, severe hearing loss, or bilateral blindness at a corrected age of 18-22 months. Secondary outcomes included continued use of respiratory therapies and somatic growth.
  
  
  RESULTS
  Fifty-seven infants had adequate data for the primary outcome. Of the 28 infants randomized to hydrocortisone, 19 (68%) died or survived with impairment compared with 22 of the 29 infants (76%) assigned to placebo (relative risk: 0.83; 95% CI, 0.61 to 1.14). The rates of death for those in the hydrocortisone and placebo groups were 31% and 41%, respectively (P = 0.42). Randomization to hydrocortisone also did not significantly affect the frequency of supplemental oxygen use, positive airway pressure support, or need for respiratory medications.
  
  
  CONCLUSIONS
  In high-risk extremely low birth weight infants, stress dose hydrocortisone therapy after 10 days of age had no statistically significant effect on the incidence of death or neurodevelopmental impairment at 18-22 months. These results may inform the design and conduct of future clinical trials.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT00167544.
authors.affiliation: Department of Pediatrics, University of Texas Medical School at Houston, Houston, TX, United States of America; Center for Perinatal Research, The Research Institute at Nationwide Children's Hospital, Columbus, OH, United States of America; Department of Pediatrics, The Ohio State University College of Medicine, Columbus, OH, United States of America; Division of Neonatology, Nationwide Children's Hospital, Columbus, OH, United States of America.
authors.forename: Nehal A
authors.initials: NA
authors.lastname: Parikh
authors.affiliation: Center for Clinical Research and Evidence-Based Medicine, University of Texas Medical School at Houston, Houston, TX, United States of America.
authors.forename: Kathleen A
authors.initials: KA
authors.lastname: Kennedy
authors.affiliation: Center for Clinical Research and Evidence-Based Medicine, University of Texas Medical School at Houston, Houston, TX, United States of America.
authors.forename: Robert E
authors.initials: RE
authors.lastname: Lasky
authors.affiliation: Center for Clinical Research and Evidence-Based Medicine, University of Texas Medical School at Houston, Houston, TX, United States of America.
authors.forename: Jon E
authors.initials: JE
authors.lastname: Tyson
mesh_terms: D004305:Dose-Response Relationship, Drug; D005260:Female; D006801:Humans; D006854:Hydrocortisone / Q000009:adverse effects* / Q000494:pharmacology*; D007223:Infant; D062071:Infant, Extremely Premature / Q000254:growth & development* / Q000502:physiology; D007231:Infant, Newborn; D008297:Male; D009420:Nervous System / Q000187:drug effects* / Q000254:growth & development*; D011247:Pregnancy; D012449:Safety; D013312:Stress, Physiological / Q000187:drug effects*; D016019:Survival Analysis
chemical_list: D006854:Hydrocortisone