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 J Monroe & 2 others J. Michael Dean, Nathan Kuppermann

Research output: Contribution to journalArticle

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

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Bronchiolitis
Dexamethasone
Hospital Emergency Service
Randomized Controlled Trials
Placebos
Observation
Length of Stay
Confidence Intervals
Respiratory Sounds
Respiratory Tract Infections
Adrenal Cortex Hormones
Hospitalization
Body Weight

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., ... 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

A multicenter, randomized, controlled trial of dexamethasone for bronchiolitis. / Corneli, Howard M.; Zorc, Joseph J.; Majahan, Prashant; Shaw, Kathy N.; Holubkov, Richard; Reeves, Scott D.; Ruddy, Richard M.; Malik, Baqir; Nelson, Kyle A.; Bregstein, Joan S.; Brown, Kathleen M.; Denenberg, Matthew N.; Lillis, Kathleen A.; Cimpello, Lynn Babcock; Tsung, James W.; Borgialli, Dominic A.; Baskin, Marc N.; Teshome, Getachew; Goldstein, Mitchell A; Monroe, David J; Dean, J. Michael; Kuppermann, Nathan.

In: New England Journal of Medicine, Vol. 357, No. 4, 26.07.2007, p. 331-339.

Research output: Contribution to journalArticle

Corneli, HM, Zorc, JJ, Majahan, P, Shaw, KN, Holubkov, R, Reeves, SD, Ruddy, RM, Malik, B, Nelson, KA, Bregstein, JS, Brown, KM, Denenberg, MN, Lillis, KA, Cimpello, LB, Tsung, JW, Borgialli, DA, Baskin, MN, Teshome, G, Goldstein, MA, Monroe, DJ, Dean, JM & Kuppermann, N 2007, 'A multicenter, randomized, controlled trial of dexamethasone for bronchiolitis', New England Journal of Medicine, vol. 357, no. 4, pp. 331-339. https://doi.org/10.1056/NEJMoa071255
Corneli HM, Zorc JJ, Majahan P, Shaw KN, Holubkov R, Reeves SD et al. A multicenter, randomized, controlled trial of dexamethasone for bronchiolitis. New England Journal of Medicine. 2007 Jul 26;357(4):331-339. https://doi.org/10.1056/NEJMoa071255
Corneli, Howard M. ; Zorc, Joseph J. ; Majahan, Prashant ; Shaw, Kathy N. ; Holubkov, Richard ; Reeves, Scott D. ; Ruddy, Richard M. ; Malik, Baqir ; Nelson, Kyle A. ; Bregstein, Joan S. ; Brown, Kathleen M. ; Denenberg, Matthew N. ; Lillis, Kathleen A. ; Cimpello, Lynn Babcock ; Tsung, James W. ; Borgialli, Dominic A. ; Baskin, Marc N. ; Teshome, Getachew ; Goldstein, Mitchell A ; Monroe, David J ; Dean, J. Michael ; Kuppermann, Nathan. / A multicenter, randomized, controlled trial of dexamethasone for bronchiolitis. In: New England Journal of Medicine. 2007 ; Vol. 357, No. 4. pp. 331-339.
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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.)",
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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 J

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.)

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