Abstract | OBJECTIVES: STUDY DESIGN: A randomized, double-blind, placebo-controlled trial included 1287 children with CHD randomly assigned 1:1 to receive 5 monthly intramuscular injections of 15 mg/kg palivizumab or placebo. Children were followed for 150 days. The primary efficacy end point was antigen-confirmed respiratory syncytial virus (RSV) hospitalization. RESULTS:
Palivizumab recipients had a 45% relative reduction in RSV hospitalizations (P=.003), a 56% reduction in total days of RSV hospitalization per 100 children (P=.003), and a 73% reduction in total RSV hospital days with increased supplemental oxygen per 100 children (P=.014). Adverse events were similar in the treatment groups; no child had drug discontinued for a related adverse event. Serious adverse events occurred in 55.4% of palivizumab recipients and 63.1% of placebo recipients (P<.005); none were related to palivizumab. Twenty-one children (3.3%) in the palivizumab group and 27 (4.2%) in the placebo group died; no deaths were attributed to palivizumab. The rates of cardiac surgeries performed earlier than planned were similar in the treatment groups. CONCLUSIONS: Monthly palivizumab (15 mg/kg IM) was safe, well-tolerated, and effective for prophylaxis of serious RSV disease in young children with hemodynamically significant CHD.
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Authors | Timothy F Feltes, Allison K Cabalka, H Cody Meissner, Franco M Piazza, David A Carlin, Franklin H Top Jr, Edward M Connor, Henry M Sondheimer, Cardiac Synagis Study Group |
Journal | The Journal of pediatrics
(J Pediatr)
Vol. 143
Issue 4
Pg. 532-40
(Oct 2003)
ISSN: 0022-3476 [Print] United States |
PMID | 14571236
(Publication Type: Clinical Trial, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Antibodies, Monoclonal
- Antibodies, Monoclonal, Humanized
- Antiviral Agents
- Palivizumab
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Topics |
- Antibodies, Monoclonal
(therapeutic use)
- Antibodies, Monoclonal, Humanized
- Antiviral Agents
(therapeutic use)
- Comorbidity
- Double-Blind Method
- Heart Defects, Congenital
(epidemiology, surgery)
- Hospitalization
(statistics & numerical data)
- Humans
- Palivizumab
- Respiration, Artificial
- Respiratory Syncytial Virus Infections
(epidemiology, prevention & control, therapy)
- Risk Factors
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