A Multicenter, Randomized, Controlled Trial of Dexamethasone for Bronchiolitis
Howard M. Corneli, M.D., Joseph J. Zorc, M.D., Prashant Mahajan, M.D., M.P.H., Kathy N. Shaw, M.D., M.S.C.E., Richard Holubkov, Ph.D., Scott D. Reeves, M.D., Richard M. Ruddy, M.D., Baqir Malik, M.D., Kyle A. Nelson, M.D., M.P.H., Joan S. Bregstein, M.D., Kathleen M. Brown, M.D., Matthew N. Denenberg, M.D., Kathleen A. Lillis, M.D., Lynn Babcock Cimpello, M.D., James W. Tsung, M.D., Dominic A. Borgialli, D.O., M.P.H., Marc N. Baskin, M.D., Getachew Teshome, M.D., M.P.H., Mitchell A. Goldstein, M.D., David Monroe, M.D., J. Michael Dean, M.D., Nathan Kuppermann, M.D., M.P.H., for the Bronchiolitis Study Group of the Pediatric Emergency Care Applied Research Network (PECARN)
Background Bronchiolitis, the most common infection of the lowerrespiratory tract in infants, is a leading cause of hospitalizationin childhood. Corticosteroids are commonly used to treat bronchiolitis,but evidence of their effectiveness is limited.
Methods We conducted a double-blind, randomized trial comparinga single dose of oral dexamethasone (1 mg per kilogram of bodyweight) with placebo in 600 children (age range, 2 to 12 months)with a first episode of wheezing diagnosed in the emergencydepartment as moderate-to-severe bronchiolitis (defined by aRespiratory Distress Assessment Instrument score 6). We enrolledpatients at 20 emergency departments during the months of Novemberthrough April over a 3-year period. The primary outcome washospital admission after 4 hours of emergency department observation.The secondary outcome was the Respiratory Assessment ChangeScore (RACS). We also evaluated later outcomes: length of hospitalstay, 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 (absolutedifference, –1.3%; 95% confidence interval [CI], –9.2to 6.5). Both groups had respiratory improvement during observation;the mean 4-hour RACS was –5.3 for dexamethasone, as comparedwith –4.8 for placebo (absolute difference, –0.5;95% CI, –1.3 to 0.3). Multivariate adjustment did notsignificantly alter the results, nor were differences detectedin later outcomes.
Conclusions In infants with acute moderate-to-severe bronchiolitiswho were treated in the emergency department, a single doseof 1 mg of oral dexamethasone per kilogram did not significantlyalter the rate of hospital admission, the respiratory statusafter 4 hours of observation, or later outcomes. (ClinicalTrials.govnumber, NCT00119002
[ClinicalTrials.gov]
.)
Source Information
From the University of Utah (H.M.C.) and Central Data Management and Coordinating Center (R.H., J.M.D.), Salt Lake City; the Children's Hospital of Philadelphia, Philadelphia (J.J.Z., K.N.S.); Children's Hospital of Michigan, Detroit (P.M., B.M.); Cincinnati Children's Hospital Medical Center, Cincinnati (S.D.R., R.M.R.); Washington University, St. Louis (K.A.N.); Columbia University, New York (J.S.B.); Children's National Medical Center, Washington, DC (K.M.B.); Devos Children's Hospital, Grand Rapids, MI (M.N.D.); Women and Children's Hospital of Buffalo, Buffalo, NY (K.A.L.); University of Rochester Medical Center, Rochester, NY (L.B.C.); Bellevue Hospital Center, New York (J.W.T.); Hurley Medical Center, Flint, MI (D.A.B.); Children's Hospital, Boston (M.N.B.); University of Maryland, Baltimore (G.T.); Johns Hopkins Children's Center, Baltimore (M.A.G.); Howard County General Hospital, Columbia, MD (D.M.); and the University of California, Davis, Medical Center, Sacramento (N.K.).
Address reprint requests to Dr. Corneli at P.O. Box 581289, Salt Lake City, UT 84158-1289.
Dexamethasone for Bronchiolitis
Shell M. S. L., Calabria C. W., Casoni G. L., Poletti V., Stafler P., Corneli H. M., Zorc J. J., Kuppermann N.
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N Engl J Med 2007;
357:1659-1660, Oct 18, 2007.
Correspondence
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A correction has been published: N Engl J Med 2008;359(18):1972.
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. 
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