title: Effects of prophylactic indomethacin in extremely low-birth-weight infants with and without adequate exposure to antenatal corticosteroids.
abstract: OBJECTIVE
  To examine whether treatment with antenatal corticosteroids modifies the immediate and long-term effects of prophylactic indomethacin sodium trihydrate in extremely low-birth-weight infants.
  
  
  METHODS
  Post hoc subgroup analysis of data from the Trial of Indomethacin Prophylaxis in Preterms.
  
  
  METHODS
  Thirty-two neonatal intensive care units in Canada, the United States, Australia, New Zealand, and Hong Kong.
  
  
  METHODS
  A total of 1195 infants with birth weights of 500 to 999 g and known exposure to antenatal corticosteroids. We defined as adequate any exposure to antenatal corticosteroids that occurred at least 24 hours before delivery.
  
  
  METHODS
  Indomethacin or placebo intravenously once daily for the first 3 days.
  
  
  METHODS
  Death or survival to 18 months with cerebral palsy, cognitive delay, severe hearing loss, or bilateral blindness; severe periventricular and intraventricular hemorrhage; patent ductus arteriosus; and surgical closure of a patent ductus arteriosus.
  
  
  RESULTS
  Of the 1195 infants in this analysis cohort, 670 had adequate and 525 had inadequate exposure to antenatal corticosteroids. There was little statistical evidence of heterogeneity in the effects of prophylactic indomethacin between the subgroups for any of the outcomes. The adjusted P values for interaction were as low as .15 for the outcome of death or impairment at 18 months and as high as .80 for the outcome of surgical duct closure.
  
  
  CONCLUSIONS
  We find little evidence that the effects of prophylactic indomethacin vary in extremely low-birth-weight infants with and without adequate exposure to antenatal corticosteroids. Trial Registration clinicaltrials.gov Identifier: NCT00009646.
authors: Department of Pediatrics, Hospital of the University of Pennsylvania, Ravdin 8, 3400 Spruce St, Philadelphia, PA 19104, USA. Barbara.Schmidt@uphs.upenn.edu
authors: Barbara
authors: B
authors: Schmidt
authors: Mary
authors: M
authors: Seshia
authors: Seetha
authors: S
authors: Shankaran
authors: Lindsay
authors: L
authors: Mildenhall
authors: Jon
authors: J
authors: Tyson
authors: Kei
authors: K
authors: Lui
authors: Tai
authors: T
authors: Fok
authors: Robin
authors: R
authors: Roberts
mesh_terms: D000305:Adrenal Cortex Hormones / Q000627:therapeutic use*; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000627:therapeutic use*; D002658:Developmental Disabilities / Q000517:prevention & control*; D005260:Female; D006801:Humans; D007213:Indomethacin / Q000627:therapeutic use*; D052577:Infant, Extremely Low Birth Weight; D007231:Infant, Newborn; D007235:Infant, Premature, Diseases / Q000517:prevention & control*; D008297:Male; D011295:Prenatal Care; D016896:Treatment Outcome
chemical_list: D000305:Adrenal Cortex Hormones; D000894:Anti-Inflammatory Agents, Non-Steroidal; D007213:Indomethacin