A multicenter, randomized, controlled trial of dexamethasone for bronchiolitis

Howard M. Corneli, Joseph J. Zorc, Prashant Majahan, 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 MonroeJ. Michael Dean, Nathan Kuppermann

Research output: Contribution to journalArticle

198 Scopus citations

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 ≥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.)

Original languageEnglish (US)
Pages (from-to)331-339
Number of pages9
JournalNew England Journal of Medicine
Volume357
Issue number4
DOIs
StatePublished - Jul 26 2007

ASJC Scopus subject areas

  • Medicine(all)

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    Corneli, H. M., Zorc, J. J., Majahan, P., Shaw, K. N., Holubkov, R., Reeves, S. D., Ruddy, R. M., Malik, B., Nelson, K. A., Bregstein, J. S., Brown, K. M., Denenberg, M. N., Lillis, K. A., Cimpello, L. B., Tsung, J. W., Borgialli, D. A., Baskin, M. N., Teshome, G., Goldstein, M. A., ... Kuppermann, N. (2007). A multicenter, randomized, controlled trial of dexamethasone for bronchiolitis. New England Journal of Medicine, 357(4), 331-339. https://doi.org/10.1056/NEJMoa071255