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A Multicenter, Randomized, Controlled Trial of Dexamethasone for Bronchiolitis

2007-08-01

Bronchiolitis, the most common infection of the lower respiratory tract in infants, is a leading cause of hospitalization in childhood. Corticosteroids are commonly used to treat bronchiolitis, but evidence of their effectiveness is limited.

A double-blind, randomized trial was performed comparing a single dose of oral dexamethasone (1 mg per kilogram of body weight) with placebo in 600 children (age range, 2 to 12 months) with a first episode of wheezing diagnosed in the emergency department as moderate-to-severe bronchiolitis (defined by a Respiratory Distress Assessment Instrument score 6). Patients were enrolled at 20 emergency departments during the months of November through April over a 3-year period. The primary outcome was hospital admission after 4 hours of emergency department observation. The secondary outcome was the Respiratory Assessment Change Score (RACS). Later outcomes were also evaluated: length of hospital stay, later medical visits or admissions, and adverse events.

Baseline characteristics were similar in the two groups. The admission rate was 39.7% for children assigned to dexamethasone, as compared with 41.0% for those assigned to placebo (absolute difference, –1.3%; 95% confidence interval [CI], –9.2 to 6.5). Both groups had respiratory improvement during observation; the mean 4-hour RACS was –5.3 for dexamethasone, as compared with –4.8 for placebo (absolute difference, –0.5; 95% CI, –1.3 to 0.3). Multivariate adjustment did not significantly alter the results, nor were differences detected in later outcomes.

In infants with acute moderate-to-severe bronchiolitis who were treated in the emergency department, a single dose of 1 mg of oral dexamethasone per kilogram did not significantly alter the rate of hospital admission, the respiratory status after 4 hours of observation, or later outcomes.

Source: New England Journal of Medicine