PEDIATRICS Vol. 119 No. 4 April 2007, pp. 716-721 (doi:10.1542/peds.2006-2806)
ARTICLE |
Outcome at 2 Years of Age of Infants From the DART Study: A Multicenter, International, Randomized, Controlled Trial of Low-Dose Dexamethasonef
a Departments of Obstetrics and Gynaecology
b Paediatrics, University of Melbourne, Melbourne, Australia
c Division of Newborn Services, Royal Women's Hospital, Melbourne, Australia
f Clinical Epidemiology and Biostatistics Unit
d Murdoch Childrens Research Institute, Melbourne, Australia
e Department of Neonatology, Women's and Children's Hospital, Adelaide, Australia
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.
Key Words: infant • preterm • low birth weight • low dose-dexamethasone • cerebral palsy • impairment • disability
Abbreviations: ELBW—extremely low birth weight • MDI—mental developmental index • PDI—psychomotor developmental index • CL—confidence limit • CLD—chronic lung disease
Accepted Dec 1, 2006.
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