Study of Inhaled Peginterferon -2b Injection Compared to Recombinant Human Interferon -2b for Treating Bronchiolitis in Children Aged 6 Months to 2 Years

What this Trial Is About

Researchers are evaluating the safety and effectiveness of inhaled Peginterferon -2b injection compared to recombinant human interferon 2b for treating bronchiolitis caused by respiratory syncytial virus RSV in children. This multicenter, randomized, positive-controlled, non-inferiority clinical study plans to enroll 90 children aged between 6 months and 2 years with mild to moderate RSV bronchiolitis. The goal is to understand how these treatments impact symptoms and recovery in pediatric patients. Participants are randomly assigned to one of two groups. The experimental group receives inhaled Peginterferon -2b injection at a dose of 90 mcg on days 1, 3, and 5, alongside standard supportive care like asthma control, oxygen therapy, and fluid replacement. The control group receives symptomatic supportive care plus aerosolized inhalation of recombinant human interferon 2b twice daily from day 1 to day 5. Both treatments are given using nebulized inhalation via air compression or oxygen-driven methods. During the study, children will be monitored for changes in symptoms using Wangs bronchiolitis score at multiple time points, including the primary endpoint on day 6. Researchers will also track hospital stay length, oxygen therapy duration, viral load changes, body temperature, adverse events, and laboratory test abnormalities over about 18 months of follow-up. The study includes safety monitoring and records any early withdrawals. This comprehensive evaluation aims to assess and compare the impact and tolerability of these treatments in young children with RSV bronchiolitis.

Peginterferon α-2b Injection for the Treatment of Pediatric RSV Bronchiolitis