Prednisolone for preschool children presenting with acute wheeze: A multicentre RCT

Background: In children aged Methods: We conducted a multicentre, double-blind, randomised controlled trial of a 3-day course of oral prednisolone (pred, 2mg/kg OD) versus placebo in children, aged 24-59mth, presenting to EDs with wheeze associated with a respiratory tract infection, regardless of previous asthma diagnosis. The primary outcome was the Preschool Respiratory Assessment Measure (PRAM score) at 24hrs. Secondary outcomes were admission rate, length of stay (LOS), and adverse events (use of IV medications or ICU admission). Results: 492 children were randomised (246 pred, 246 placebo); 147 (30.6%) previous physician diagnosis of asthma; mean (SD) age was 36.6 (±10.0) mth; mean PRAM score at presentation was 5.7 (±1.9). Median (IQR) PRAM score at 24hrs was 0 (0 to 1) in pred participants and 0 (0 to 1.5) in placebo participants, p=0.01. 55 (23.0%) pred and 74 (31.1%) placebo children were admitted (RR=0.66, 95%CI 0.44 to 1.00, p=0.05). Median (IQR) LOS was 6.8 (4.5 to 13.8) hrs in pred participants and 7.7 (5.0 to 22.9) hrs in placebo participants, p=0.03. 3 (1.2%) pred and 11 (4.5%) placebo children had an adverse event (RR=0.26, 95%CI 0.07 to 0.96, p=0.04). Conclusions: Treatment with 3-days of oral prednisolone in children, aged 24-59mth, presenting to EDs with wheeze is associated with a statistical, but not clinical, significant improvement in PRAM score at 24hrs. However, those treated with prednisolone had a decreased LOS, and required less admission to hospital, use of IV medications or admission to ICU.