title: Outcome at 2 years of age of infants from the DART study: a multicenter, international, randomized, controlled trial of low-dose dexamethasone.
abstract: OBJECTIVE
  Low-dose dexamethasone facilitates extubation in chronically ventilator-dependent infants with no obvious short-term complications. The objective of this study was to determine the long-term effects of low-dose dexamethasone.
  
  
  METHODS
  Very preterm (<28 weeks' gestation) or extremely low birth weight (birth weight <1000 g) infants who were ventilator dependent after the first week of life for whom clinicians considered corticosteroids were indicated were eligible. After informed consent, infants were randomly assigned to masked dexamethasone (0.89 mg/kg over 10 days) or saline placebo. Survivors were assessed at 2 years' corrected age by staff blinded to treatment group allocation to determine neurosensory outcome, growth, and health.
  
  
  RESULTS
  The trial was abandoned well short of its target sample size because of recruitment difficulties. Seventy infants were recruited from 11 centers, 35 in each group: 59 survived to 2 years of age, and 58 (98%) were assessed at follow-up, but data for cerebral palsy were available for only 56 survivors. There was little evidence for a difference in the major end point, the rate of the combined outcome of death, or major disability at 2 years of age (dexamethasone group: 46%; controls: 43%). Rates of mortality before follow-up (11% vs 20%), major disability (41% vs 31%), cerebral palsy (14% vs 22%), or of the combined outcomes of death or cerebral palsy (23% vs 37%) were not substantially different between the groups. There were no obvious effects of low-dose dexamethasone on growth or readmissions to hospital after discharge.
  
  
  CONCLUSIONS
  Although this trial was not able to provide definitive evidence on the long-term effects of low-dose dexamethasone after the first week of life in chronically ventilator-dependent infants, our data indicate no strong association with long-term morbidity.
authors.affiliation: Department of Obstetrics and Gynaecology, University of Melbourne, Melbourne, Australia. lwd@unimelb.edu.au
authors.forename: Lex W
authors.initials: LW
authors.lastname: Doyle
authors.forename: Peter G
authors.initials: PG
authors.lastname: Davis
authors.forename: Colin J
authors.initials: CJ
authors.lastname: Morley
authors.forename: Andy
authors.initials: A
authors.lastname: McPhee
authors.forename: John B
authors.initials: JB
authors.lastname: Carlin
mesh_terms: D002675:Child, Preschool; D003907:Dexamethasone / Q000008:administration & dosage*; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007223:Infant; D052577:Infant, Extremely Low Birth Weight; D007231:Infant, Newborn; D007234:Infant, Premature; D007363:Intensive Care Units, Neonatal; D007391:International Cooperation; D008297:Male; D011336:Probability; D012016:Reference Values; D012121:Respiration, Artificial / Q000009:adverse effects / Q000379:methods; D012127:Respiratory Distress Syndrome, Newborn / Q000175:diagnosis / Q000188:drug therapy* / Q000401:mortality / Q000628:therapy; D018570:Risk Assessment; D018709:Statistics, Nonparametric; D015996:Survival Rate; D016896:Treatment Outcome
chemical_list: D003907:Dexamethasone