Early inhaled glucocorticoid therapy to prevent bronchopulmonary dysplasia

Background The safety and efficacy of inhaled glucocorticoid therapy for as thma stimulated its use in infants to prevent bronchopulmonary dysplasia. W e tested the hypothesis that early therapy with inhaled glucocorticoids wou ld decrease the frequency of bronchopulmonary dysplasia in premature infant s. Methods We conducted a randomized, multicenter trial of inhaled beclomethas one or placebo in 253 infants, 3 to 14 days old, born before 33 weeks of ge station and weighing 1250 g or less at birth, who required ventilation ther apy. Beclomethasone was delivered in a decreasing dosage, from 40 to 5 mu g per kilogram of body weight per day, for four weeks. The primary outcome m easure was bronchopulmonary dysplasia at 28 days of age. Secondary outcomes included bronchopulmonary dysplasia at 36 weeks of postmenstrual age, the need for systemic glucocorticoid therapy, the need for bronchodilator thera py, the duration of respiratory support, and death. Results One hundred twenty-three infants received beclomethasone, and 130 r eceived placebo. The frequency of bronchopulmonary dysplasia was similar in the two groups: 43 percent in the bedomethasone group and 45 percent in th e placebo group at 28 days of age, and 18 percent in the beclomethasone gro up and 20 percent in the placebo group at 36 weeks of postmenstrual age. At 28 days of age, fewer infants in the beclomethasone group than in the plac ebo group were receiving systemic glucocorticoid therapy (relative risk, 0. 6; 95 percent confidence interval, 0.4 to 1.0) and mechanical ventilation ( relative risk, 0.8; 95 percent confidence interval, 0.6 to 1.0). Conclusions Early beclomethasone therapy did not prevent bronchopulmonary d ysplasia but was associated with lower rates of use of systemic glucocortic oid therapy and mechanical ventilation. (N Engl J Med 1999;340:1005-10.) (C ) 1999, Massachusetts Medical Society.