Oral prednisolone in the acute management of children age 6 to 35 months with viral respiratory infection-induced lower airway disease: A randomized, placebo-controlled trial
Article Outline
Context The role of systemic corticosteroids in the treatment of infants and toddlers with acute viral respiratory infection-induced lower airway disease has been controversial, especially for initial occurrences.
Objectives To investigate the efficacy of oral prednisolone in viral respiratory infection-induced lower airway disease.
Design Randomized, double-blind, placebo-controlled trial.
Setting University hospital in Finland.
Participants 230 children ages 6 to 35 months with no more than one previous episode of viral respiratory infection-induced lower airway disease seen in the emergency department.
Intervention Oral prednisolone, 2 mg/kg initially and 1 mg/kg/day twice per day or placebo for 3 days.
Main outcome measures The primary outcome measure was development of severe respiratory symptoms requiring additional asthma medication. The secondary outcome measures were hospitalization rate from the emergency department, median hospital length of stay, hospitalizations for ≥3 days, median duration of symptoms, proportion of children with ≥3 symptomatic days, and further medical care visits after hospitalization.
Results 37% of the placebo-treated patients required additional asthma medication versus 18% of the prednisolone-treated patients (P
=.018, NNT=5). Hospitalization rate, with decision made after 4.3 ± 1.9 hours (mean ± SD) in the emergency department, was similar for the 2 groups at 53% and 54%, but the mean length of stay was 1 day shorter for the prednisolone-treated patients (mean of 3 vs 2 days, P=.06), and hospital stays of at least 3 days were greater in the placebo-treated group (67% vs 48%, P=.023, NNT=5). Median duration of symptoms was less in the prednisolone-treated patients (2 vs 1 day, P ≤ .001), and the proportion of children with 3 or more symptomatic days was less in the prednisolone treated patients (39% vs 19%, P=.001, NNT=5). Differences in revisits for medical care within 14 days after hospitalization were not significant. Similar differences were seen between placebo- and prednisolone-treated patients for those with no previous wheezing reported and those who had a previous wheezing episode.
Conclusion A 3-day course of oral prednisolone effectively reduced disease severity, length of hospital stay, and the duration of symptoms among children 6 to 35 months old with viral-induced respiratory distress.
Comment Bronchiolitis, the diagnostic term generally used for first-time wheezing with a viral respiratory infection, is the leading cause of hospitalization in infants.1., 2. Although corticosteroids have commonly been used for bronchiolitis, conflicting data has resulted in skepticism regarding their clinical usefulness.3., 4.
The magnitude of benefit from corticosteroid treatment described in this study of patients treated in the emergency department was larger than in previous studies included in a meta-analysis where patients were treated subsequent to hospitalization.5 A previous emergency department study also found prednisolone to be associated with more rapid improvement.6 Although the current report found no effect of prednisolone on decisions to hospitalize about 4 hours after coming to the emergency department, a study by Schuh and colleagues7 using a considerably higher dose of corticosteroid in the emergency department (1 mg/kg of dexamethasone, equivalent to about 5 mg/kg of prednisolone), reported a substantial decrease in hospitalization over about the same time period.
The current study would have provided clearer guidance had the authors limited intake to infants with no prior episodes. Nonetheless, the similarity of outcome in those with a previous episode and those with no previous episode combined with the previous reports in the emergency department setting supports early treatment of bronchiolitis with a short course of high-dose oral corticosteroid. The value of beginning corticosteroids for bronchiolitis later in the course after hospitalization remains less certain.
References
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PII: S0022-3476(04)00355-5
doi:10.1016/j.jpeds.2004.04.041
© 2004 Elsevier Inc. All rights reserved.
