title: Pilot randomized trial of hydrocortisone in ventilator-dependent extremely preterm infants: effects on regional brain volumes.
abstract: OBJECTIVE
  To test the hypothesis that high-risk ventilator-dependent extremely low birth weight (birth weight ≤1000 g) infants treated with 7 days of hydrocortisone will have larger total brain tissue volumes than placebo treated infants.
  
  
  METHODS
  A predetermined sample size of 64 extremely low birth weight infants, between 10-21 days old and ventilator-dependent with a respiratory index score ≥2, were randomized to systemic hydrocortisone (17 mg/kg cumulative dose) or saline placebo. Primary outcome was total brain tissue volume. Volumetric magnetic resonance imaging was performed at 38 weeks postmenstrual age; brain tissue regions were segmented and quantified automatically with a high degree of accuracy and 9 structures were segmented manually. All analyses of regional brain volumes were adjusted by postmenstrual age at magnetic resonance imaging scan.
  
  
  RESULTS
  The study groups were similar at baseline and 8 infants died in each arm. Unadjusted total brain tissue volume (mean ± SD) in the hydrocortisone (N = 23) and placebo treated infants (N = 21) was 272 ± 40.3 cm(3) and 277.8 ± 59.1 cm(3), respectively (adjusted mean difference: 6.35 cm(3) (95% CI: (-20.8, 32.5); P = .64). Three of the 31 hydrocortisone treated infants and 5 of the 33 placebo treated infants survived without severe bronchopulmonary dysplasia (relative risk 0.62, 95% CI: 0.13, 2.66; P = .49). No significant differences were noted in prespecified secondary outcomes of regional structural volumes or days on respiratory support. No adverse effects of hydrocortisone were observed.
  
  
  CONCLUSIONS
  Low dose hydrocortisone in high-risk ventilator-dependent infants after a week of age had no discernible effect on regional brain volumes or pulmonary outcomes prior to neonatal intensive care unit discharge.
authors.affiliation: Department of Pediatrics, Neonatal-Perinatal Medicine, University of Texas Medical School at Houston, Houston, TX, USA. Nehal.Parikh@NationwideChildrens.org
authors.forename: Nehal A
authors.initials: NA
authors.lastname: Parikh
authors.forename: Kathleen A
authors.initials: KA
authors.lastname: Kennedy
authors.forename: Robert E
authors.initials: RE
authors.lastname: Lasky
authors.forename: Georgia E
authors.initials: GE
authors.lastname: McDavid
authors.forename: Jon E
authors.initials: JE
authors.lastname: Tyson
mesh_terms: D000886:Anthropometry / Q000379:methods; D001921:Brain / Q000187:drug effects / Q000473:pathology*; D001930:Brain Injuries / Q000517:prevention & control; D001997:Bronchopulmonary Dysplasia / Q000517:prevention & control* / Q000628:therapy; D005260:Female; D006801:Humans; D006854:Hydrocortisone / Q000627:therapeutic use*; D052577:Infant, Extremely Low Birth Weight; D007231:Infant, Newborn; D007234:Infant, Premature; D008279:Magnetic Resonance Imaging / Q000379:methods; D008297:Male; D010919:Placebos; D015203:Reproducibility of Results; D012121:Respiration, Artificial; D012306:Risk; D016896:Treatment Outcome
chemical_list: D010919:Placebos; D006854:Hydrocortisone