PEDIATRICS Vol. 108 No. 3 September 2001, pp. 741-748
Early Postnatal Dexamethasone Therapy for the Prevention of Chronic Lung Disease
Received Aug 30, 2000; accepted May 7, 2001.
From the Department of Pediatrics, University of Vermont
College of Medicine, Burlington, Vermont.
Objective. To test the hypothesis
that early postnatal dexamethasone will reduce the incidence of death
or chronic lung disease (CLD) in ventilated extremely low birth weight
premature infants.
Design. Multicenter randomized double-blinded controlled
clinical trial.
Setting. A total of 42 neonatal intensive care units in
the Vermont Oxford Network.
Participants. Infants weighing 501 to 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.
Intervention. Infants were randomly assigned to
dexamethasone or saline placebo. Intravenous dexamethasone was
administered for 12 days according to the following dosing schedule:
0.5 mg/kg/d for 3 days, 0.25 mg/kg/d for 3 days, 0.10 mg/kg/d for 3 days, 0.05 mg/kg/d for 3 days. Infants in either group could receive
treatment with selective late postnatal steroids beginning on day 14 of
life if they were on assisted ventilation with supplemental oxygen greater than 30%.
Outcome Measurements. The primary outcome measure was CLD
or death at 36 weeks postmenstrual age.
Results. The study was stopped before completion of sample
size goals because of concern about serious side effects in the early
steroid treatment group. A total of 542 infants were enrolled (early
treatment N = 273, control N = 269). The 2 groups had similar demographic characteristics. No
differences were noted in the primary outcome of CLD or death at 36 weeks postmenstrual age (early treatment 50% vs control: 53%,
relative risk: 0.93; 95% confidence interval [CI]: 0.79-1.09).
Fewer infants who received early steroid treatment had a patent ductus
arteriosus (relative risk: 0.78; 95% CI: 0.63-0.96), and fewer
infants in the early steroid group received indomethacin therapy
(relative risk: 0.74; 95% CI: 0.64-0.86) or late steroid treatment
(relative risk: 0.69; 95% CI: 0.58-0.81). However, more infants who
received early steroid treatment had complications associated with
therapy including an increase in hyperglycemia (relative risk: 1.29;
95% CI: 1.13-1.46) and an increase in the use of insulin therapy
(relative risk: 1.62; 95% CI: 1.36-1.94). A trend toward increased
gastrointestinal hemorrhage (relative risk: 1.55; 95% CI: 0.92-2.61),
gastrointestinal perforation (relative risk: 1.53; 95% CI:
0.89-2.61), and an increased systolic blood pressure (relative risk:
1.34; 95% CI: 0.97-1.85) was noted. In infants receiving cranial
ultrasound examinations, a marginal increase in periventricular
leukomalacia was noted in the early steroid treatment group (relative
risk: 2.23; 95% CI: 0.99-5.04). Infants who received early steroid
therapy had fewer days in supplemental oxygen but experienced poor
weight gain.
Conclusions. A 12-day course of early postnatal steroid
therapy given to extremely low birth weight infants did not decrease
the risk of CLD or death at 36 weeks postmenstrual age and was
associated with an increased risk of complications and poor weight
gain.
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