Oral prednisolone for preschool children with acute virus-induced wheezing.

Author(s): Panickar J, Lakhanpaul M, Lambert PC, Kenia P, Stephenson T, Smyth A, Grigg J

Affiliation(s): Division of Child Health, University of Leicester, Leicester, United Kingdom.

Publication date & source: 2009-01-22, N Engl J Med., 360(4):329-38.

Publication type: Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't

BACKGROUND: Attacks of wheezing induced by upper respiratory viral infections are common in preschool children between the ages of 10 months and 6 years. A short course of oral prednisolone is widely used to treat preschool children with wheezing who present to a hospital, but there is conflicting evidence regarding its efficacy in this age group. METHODS: We conducted a randomized, double-blind, placebo-controlled trial comparing a 5-day course of oral prednisolone (10 mg once a day for children 10 to 24 months of age and 20 mg once a day for older children) with placebo in 700 children between the ages of 10 months and 60 months. The children presented to three hospitals in England with an attack of wheezing associated with a viral infection; 687 children were included in the intention-to-treat analysis (343 in the prednisolone group and 344 in the placebo group). The primary outcome was the duration of hospitalization. Secondary outcomes were the score on the Preschool Respiratory Assessment Measure, albuterol use, and a 7-day symptom score. RESULTS: There was no significant difference in the duration of hospitalization between the placebo group and the prednisolone group (13.9 hours vs. 11.0 hours; ratio of geometric means, 0.90; 95% confidence interval, 0.77 to 1.05) or in the interval between hospital admission and signoff for discharge by a physician. In addition, there was no significant difference between the two study groups for any of the secondary outcomes or for the number of adverse events. CONCLUSIONS: In preschool children presenting to a hospital with mild-to-moderate wheezing associated with a viral infection, oral prednisolone was not superior to placebo. (Current Controlled Trials number, ISRCTN58363576.) 2009 Massachusetts Medical Society