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Monoclonal Antibody Treatment of RSV Bronchiolitis in Young Infants: A Randomized Trial
Khalid Alansari1,2,3, Fatihi Hassan Toaimah4, Daher Helmi Almatar4
1Division of Pediatric Emergency Medicine, Department of Pediatrics, Hamad Medical Corporation, Doha, Qatar; dkmaa@hotmail.com.
Insights
Palivizumab (monoclonal antibody) did not improve outcomes for young infants hospitalized with respiratory syncytial virus (RSV) bronchiolitis. This study found no significant difference in readmission rates or hospital discharge times between palivizumab and placebo groups.
Area of Science:
- Pediatrics
- Infectious Diseases
- Immunology
Background:
- Monoclonal antibody palivizumab is recommended for respiratory syncytial virus (RSV) prophylaxis in high-risk infants.
- Its efficacy for treating established RSV bronchiolitis in young infants is not well-established.
Purpose of the Study:
- To evaluate the effectiveness of palivizumab for treating acute RSV bronchiolitis in infants.
- To determine if palivizumab impacts readmission rates, hospital discharge time, or PICU admission in infants with RSV bronchiolitis.
Main Methods:
- A double-blind, randomized trial involving infants ≤3 months old with RSV-positive bronchiolitis requiring hospitalization.
- Participants received a single intravenous dose of palivizumab (15 mg/kg) or a placebo.
- Primary outcome was 3-week inpatient readmission; secondary outcomes included time to discharge readiness and PICU admission.
Main Results:
- No significant difference in readmission rates between palivizumab (11%) and placebo (9.3%) groups (P = .51).
- Similar geometric mean time to readiness for hospital discharge for both groups (29.5 vs 30.2 hours).
- No safety concerns were reported with palivizumab administration.
Conclusions:
- Intravenous palivizumab did not demonstrate a benefit in treating acute RSV bronchiolitis in young infants.
- Palivizumab was found to be safe but ineffective for this indication.
Background:
Monoclonal antibody to respiratory syncytial virus (RSV; palivizumab) is recommend for prophylaxis of high-risk infants during bronchiolitis seasons but not for RSV bronchiolitis treatment. Our aim was to determine if palivizumab would be helpful in young infants with acute RSV bronchiolitis.
Methods:
Eligible infants ≤3 months old presenting to the pediatric emergency service with RSV-positive bronchiolitis requiring inpatient admission underwent double-blind random assignment to single-dose intravenous palivizumab (15 mg/kg) or placebo. The primary efficacy outcome was the need for inpatient readmission in the 3 weeks after discharge. Secondary outcomes were time to readiness for hospital discharge, need for PICU on the initial admission, and need for revisit not requiring readmission for the same illness during 3-week follow-up.
Results:
A total of 420 infants (median age 49 days) diagnosed with RSV bronchiolitis were randomly assigned; 417 received treatment, and 413 completed follow-up. Readmission during follow-up was needed for 23 (11%) patients on palivizumab and 19 (9.3%) patients in the placebo group (difference 1.8%; 95% confidence interval -4.4% to 7.7%; P = .51). Geometric mean time to readiness for discharge was 29.5 hours for the palivizumab group and 30.2 hours for the placebo group (ratio 0.98; 95% confidence interval 0.81 to 1.20). No safety issues were reported.
Conclusions:
Intravenous palivizumab did not appear to help or harm young infants with acute RSV-positive bronchiolitis.
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