Study of Oral Prednisolone to Treat Acute Rhinovirus-Induced Wheezing in Children Under 2 Years Old

What this Trial Is About

Researchers are evaluating whether giving oral prednisolone based on quick point-of-care test results can help treat sudden wheezing caused by rhinovirus in children aged 6 to 24 months. This randomized, double-blind, placebo-controlled Phase 4 trial focuses on acute viral bronchiolitis in young children who require salbutamol treatment and have a confirmed rhinovirus or picornavirus infection. The study aims to understand if targeted treatment can improve recovery and reduce hospital stay. Participants are randomly assigned to receive either prednisolone sodium phosphate oral suspension or a sugar syrup placebo. The prednisolone dose is 1 mgkg once daily for three days, with a maximum of 20 mg per dose adjusted by weight. The placebo is given in the same volume and schedule to match the active treatment. The study uses triple masking to keep patients, caregivers, and researchers unaware of the treatment allocation. During the study, children will be monitored for several outcomes including length of hospital stay, need for intensive care, oxygen use, symptom scores, recurrence of wheezing, cough duration, and use of asthma medications. Assessments occur within days to months after study entry, with follow-up up to 24 months. Safety and treatment effects are closely observed through hospital records and symptom tracking, with the primary outcome focusing on hospital stay length within 7 days of starting treatment.

Oral Prednisolone for Acute Rhinovirus Induced Wheezing in Children Less Than 2 Years of Age