Early Postnatal Dexamethasone Therapy for the Prevention of Chronic Lung Disease. The Vermont Oxford Network Steroid Study Group. Pediatrics 2001 (Sep); 108: 741- 748.

This multi-center trial of early postnatal steroids was done in 42 NICUs participating in the Vermont Oxford Network. Infants weighing 501 – 1000 g were eligible for enrollment at 12 hours of age if they needed assisted ventilation, had received surfactant replacement therapy, were physiologically stable, had no obvious life-threatening congenital anomaly, and had blood cultures obtained and antibiotic therapy initiated. 542 infants were randomly assigned to receive dexamethasone (0.5 mg/kg/d x 3 days, then a tapering dose over 9 days) or saline placebo.

Results: The study was stopped before completion on sample size goals because of concern about serious side effects in the steroid treatment group. No differences were noted between groups in the primary outcome of death or chronic lung disease at 36 weeks PMA (early treatment 50% vs. control 53%; relative risk 0.93 (95% CI: 0.79 – 1.09)). Fewer infants in the early treatment group had patent ductus arteriosus (RR = 0.78; 95% CI = 0.63 – 0.96). More infants who received early steroid treatment had complications of therapy including increased rates of hyperglycemia, GI hemorrhage, GI perforation, and hypertension. The babies in the early steroid group also had a marginally increased risk of periventricular leukomalacia (RR = 2.3; (95% CI = 0.99 – 5.04). Infants in the early steroid group had fewer days on supplemental oxygen, but experienced poor weight gain.