[HTML][HTML] A multicenter, randomized, controlled trial of dexamethasone for bronchiolitis

HM Corneli, JJ Zorc, P Mahajan… - … England Journal of …, 2007 - Mass Medical Soc
HM Corneli, JJ Zorc, P Mahajan, KN Shaw, R Holubkov, SD Reeves, RM Ruddy, B Malik…
New England Journal of Medicine, 2007Mass Medical Soc
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 …
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.)
The New England Journal Of Medicine