Early Inhaled Glucocorticoid Therapy for Prevention of Neonatal Chronic Lung Disease • 1629

Abstract

Background: Systemic steroid therapy is widely used in treating infants at risk for chronic lung disease. Inhaled steroid therapy has potential advantages of direct delivery to the lung and fewer side effects.Methods:A multicenter, randomized, placebo-controlled, double-blind clinical trial was designed to test the hypothesis that early administration of inhaled beclomethasone would decrease the frequency of chronic lung disease with few systemic side effects. Infants <33 weeks gestation and <1251 grams birth weight still requiring assisted ventilation between days 3-14 of life were screened for enrollment. Infants were randomized to receive beclomethasone or placebo by metered dose inhaler and Aerochamber. Beclomethasone dose of 40 μg/kg/day was tapered over 4 weeks. Systemic steroid therapy was permitted if indicated. Outcome measures included frequency of chronic lung disease at age 28 days and at 36 weeks postconceptional age; death; frequency of systemic steroid therapy; duration of supplemental oxygen and mechanical ventilation. Occurrence of adverse effects, such as hyperglycemia, hypertension, infection, and decreased weight gain, were monitored. Results: 253 of 294 (86%) eligible infants were enrolled, randomized, and received either beclomethasone (n=123) or placebo (n=130). Baseline characteristics were similar between groups. Deaths by age 28 days: 7 beclomethasone v. 7 placebo. Deaths by 36 weeks postconceptional age: 11 beclomethasone v. 8 placebo. Among survivors, the study groups had similar frequency of chronic lung disease at age 28 days and 36 weeks postconceptional age. However, there was substantially less use of systemic steroid therapy in infants in the beclomethasone group v. placebo group at age 28 days and 36 weeks postconceptional age. The data also suggest that beclomethasone group had fewer days of supplemental oxygen and mechanical ventilation. There was no difference between groups with respect to death, systemic infection, blood glucose screens, blood pressures, weight gain, or ROP. Conclusion: Risk of chronic lung disease at age 28 days and 36 weeks postconceptional age was similar for infants treated with this regimen of early inhaled beclomethasone compared to placebo. Beclomethasone therapy resulted in less use of systemic steroid therapy. Increased used of systemic steroid therapy in the placebo group may have contributed to dampening detectable differences in chronic lung disease between the study groups.