Palivizumab prophylaxis reduces hospitalization due to respiratory syncytial virus in young children with hemodynamically significant congenital heart disease
- PMID: 14571236
- DOI: 10.1067/s0022-3476(03)00454-2
Palivizumab prophylaxis reduces hospitalization due to respiratory syncytial virus in young children with hemodynamically significant congenital heart disease
Abstract
Objectives: To evaluate the safety, tolerance, and efficacy of palivizumab in children with hemodynamically significant congenital heart disease (CHD).
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.
Comment in
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Palivizumab and congenital heart disease.J Pediatr. 2004 Jun;144(6):837. doi: 10.1016/j.jpeds.2004.03.028. J Pediatr. 2004. PMID: 15212065 No abstract available.
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High risk of nosocomial-acquired RSV infection in children with congenital heart disease.J Pediatr. 2004 Jul;145(1):140; author reply 140-1. doi: 10.1016/j.jpeds.2004.03.029. J Pediatr. 2004. PMID: 15264354 No abstract available.
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Annual variation in respiratory syncytial virus season and decisions regarding immunoprophylaxis with palivizumab.Pediatrics. 2004 Oct;114(4):1082-4. doi: 10.1542/peds.2004-1300. Pediatrics. 2004. PMID: 15466107 No abstract available.
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