A multicenter, randomized, controlled trial of dexamethasone for bronchiolitis.
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].).
Corneli
Howard M
HM
University of Utah, Salt Lake City, USA.
Zorc
Joseph J
JJ
Mahajan
Prashant
P
Majahan
Prashant
P
Shaw
Kathy N
KN
Holubkov
Richard
R
Reeves
Scott D
SD
Ruddy
Richard M
RM
Malik
Baqir
B
Nelson
Kyle A
KA
Bregstein
Joan S
JS
Brown
Kathleen M
KM
Denenberg
Matthew N
MN
Lillis
Kathleen A
KA
Cimpello
Lynn Babcock
LB
Tsung
James W
JW
Borgialli
Dominic A
DA
Baskin
Marc N
MN
Teshome
Getachew
G
Goldstein
Mitchell A
MA
Monroe
David
D
Dean
J Michael
JM
Kuppermann
Nathan
N
D000284:Administration, Oral; D001988:Bronchiolitis / Q000188:drug therapy* / Q000503:physiopathology; D003907:Dexamethasone / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D004636:Emergency Service, Hospital; D005260:Female; D005938:Glucocorticoids / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D006760:Hospitalization / Q000706:statistics & numerical data; D006801:Humans; D007223:Infant; D008297:Male; D012119:Respiration; D012135:Respiratory Sounds / Q000187:drug effects; D017211:Treatment Failure
D005938:Glucocorticoids; D003907:Dexamethasone