Actively Recruiting
A Multicenter, Randomized, Positive-controlled Study to Evaluate Peginterferon -2b Injection for Pediatric RSV Bronchiolitis
Led by Children's Hospital of Soochow University · Updated on 2025-02-14
90
Participants Needed
3
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
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 Wang's 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.
CONDITIONS
Brief Title
Peginterferon α-2b Injection for the Treatment of Pediatric RSV Bronchiolitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- The child's guardian understands the study and consents to participate.
- Child is between 6 months and 2 years old at consent.
- Positive RSV viral detection in nasopharyngeal swab.
- Presence of rapid breathing, wheezing, moist lung sounds; chest imaging may show specific signs.
- Mild or moderate illness severity based on Wang Bronchiolitis Scoring Standard.
- Symptoms related to RSV bronchiolitis started within 72 hours before consent.
- No use of antiviral drugs or immunomodulators in the 3 weeks before randomization.
You will not qualify if you...
- Severe restlessness, drowsiness, coma, or need for mechanical ventilation.
- Severe chronic diseases such as heart, lung, liver, kidney failure, or severe malnutrition.
- Autoimmune or immunodeficiency diseases.
- Epilepsy or other central nervous system disorders.
- Suspected bacterial infection.
- Diagnosis or suspicion of myocarditis.
- Allergy to interferon or its components.
- Participation in other clinical trials within 3 months or planned during this study.
- History of pneumonia in the past 3 months.
- Other conditions deemed unsuitable by the investigator.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 5 days
Participants receive Peginterferon α-2b injection or recombinant human interferon α-2b by nebulized inhalation along with conventional treatments such as asthma control, oxygen inhalation, and fluid replacement.
Daily visits for 5 days
Duration - Up to 18 months
Participants are monitored for safety, clinical outcomes, and other health measures after treatment completion.
Periodic visits up to 18 months
Trial Site Locations
Total: 3 locations
1
Wuhan Women and Children's Health Care Center
Wuhan, Hubei, China
Not Yet Recruiting
2
Children's Hospital of Soochow University
Suzhou, Jiangsu, China
Actively Recruiting
3
The First Hospital of Jilin University
Changchun, Jilin, China
Not Yet Recruiting
Research Team
C
Chuangli Hao, Ph.D
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here