A multicenter, randomized, controlled trial of dexamethasone for bronchiolitis
Howard M Corneli, Joseph J Zorc, Prashant Mahajan, Kathy N Shaw, Richard Holubkov, Scott D Reeves, Richard M Ruddy, Baqir Malik, Kyle A Nelson, Joan S Bregstein, Kathleen M Brown, Matthew N Denenberg, Kathleen A Lillis, Lynn Babcock Cimpello, James W Tsung, Dominic A Borgialli, Marc N Baskin, Getachew Teshome, Mitchell A Goldstein, David Monroe, J Michael Dean, Nathan Kuppermann, Bronchiolitis Study Group of the Pediatric Emergency Care Applied Research Network (PECARN), Howard M Corneli, Joseph J Zorc, Prashant Mahajan, Kathy N Shaw, Richard Holubkov, Scott D Reeves, Richard M Ruddy, Baqir Malik, Kyle A Nelson, Joan S Bregstein, Kathleen M Brown, Matthew N Denenberg, Kathleen A Lillis, Lynn Babcock Cimpello, James W Tsung, Dominic A Borgialli, Marc N Baskin, Getachew Teshome, Mitchell A Goldstein, David Monroe, J Michael Dean, Nathan Kuppermann, Bronchiolitis Study Group of the Pediatric Emergency Care Applied Research Network (PECARN)
Abstract
Background: 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.
Methods: We conducted a double-blind, randomized trial 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 > or =6). We enrolled patients 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). We also evaluated later outcomes: length of hospital stay, later medical visits or admissions, and adverse events.
Results: 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.
Conclusions: 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. (ClinicalTrials.gov number, NCT00119002 [ClinicalTrials.gov].).
Copyright 2007 Massachusetts Medical Society.
Source: PubMed