Oral prednisolone demonstrated a clear benefit over placebo in reducing length of hospital stay and was well tolerated in children with virus-associated wheeze, according to a study published in Lancet Respiratory Medicine.
Researchers conducted a noninferiority double-blind trial to compare the efficacy of placebo with that of oral prednisolone in children aged 24 to 72 months who presented to the pediatric emergency department of Princess Margaret Hospital in Perth, Western Australia, with virus-associated wheeze.
The primary outcome was the total length of hospital stay. Following analysis to test the hypothesis that placebo is noninferior to prednisolone, the investigators conducted a post-hoc superiority analysis to determine whether prednisolone was superior to placebo.
Between June 11, 2012 and June 10, 2015, 624 children were randomly assigned to either placebo or prednisolone (1 mg/kg/d) for 3 days; 605 patients were included in the modified intention-to-treat analysis — 300 from the placebo group and 305 from the prednisolone group.
The median length of stay until discharge was longer in the placebo group (540 minutes) than in the prednisolone group (370 minutes). In the post-hoc analysis, the unadjusted ratio of geometric mean for length of stay was 0.79 for the prednisolone group relative to the placebo group (P =.0227). No serious adverse events occurred during the study or in the follow-up period.
The study was limited by being conducted in a single center and by the difficulty recruiting participants because of dependence on clinical staff in a busy pediatric emergency department. Rotational staff required repeated training to attain consistent recruitment. Furthermore, follow-up data were not complete; however, 95% of patients had at least one follow-up contact.
The authors noted that the greatest benefit was seen in patients who had severe wheeze at presentation, had been taking salbutamol before presentation, or had a history of asthma. A past or family history of atopy or the presence of a virus on sampling did not predict response to therapy.
Foster SJ, Cooper MN, Oosterhof S, Borland ML. Oral prednisolone in preschool children with virus-associated wheeze: a prospective, randomised, double-blind, placebo-controlled trial [published online January 15, 2018]. Lancet Respir Med. doi:10.1016/S2213-2600(18)30008-0