TY - JOUR
T1 - A multicenter, randomized, controlled trial of dexamethasone for bronchiolitis
AU - Corneli, Howard M.
AU - Zorc, Joseph J.
AU - Majahan, Prashant
AU - Shaw, Kathy N.
AU - Holubkov, Richard
AU - Reeves, Scott D.
AU - Ruddy, Richard M.
AU - Malik, Baqir
AU - Nelson, Kyle A.
AU - Bregstein, Joan S.
AU - Brown, Kathleen M.
AU - Denenberg, Matthew N.
AU - Lillis, Kathleen A.
AU - Cimpello, Lynn Babcock
AU - Tsung, James W.
AU - Borgialli, Dominic A.
AU - Baskin, Marc N.
AU - Teshome, Getachew
AU - Goldstein, Mitchell A.
AU - Monroe, David
AU - Dean, J. Michael
AU - Kuppermann, Nathan
PY - 2007/7/26
Y1 - 2007/7/26
N2 - 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.)
AB - 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.)
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U2 - 10.1056/NEJMoa071255
DO - 10.1056/NEJMoa071255
M3 - Article
C2 - 17652648
AN - SCOPUS:34547230736
SN - 0028-4793
VL - 357
SP - 331
EP - 339
JO - New England Journal of Medicine
JF - New England Journal of Medicine
IS - 4
ER -