Palivizumab prophylaxis reduces hospitalization due to respiratory syncytial virus in young children with hemodynamically significant congenital heart disease

Palivizumab prophylaxis reduces hospitalization due to respiratory syncytial virus in young children with hemodynamically significant congenital heart disease

To evaluate the safety, tolerance, and efficacy of palivizumab in children with hemodynamically significant congenital heart disease (CHD). A randomized, double-blind, placebo-controlled trial included 1287 children with CHD randomly assigned 1:1 to receive 5 monthly intramuscular injections of 15 m...

Full description

Saved in:
Bibliographic Details
Published in:The Journal of pediatrics Vol. 143; no. 4; pp. 532 - 540
Main Authors: Feltes, Timothy F, Cabalka, Allison K, Meissner, H.Cody, Piazza, Franco M, Carlin, David A, Top, Franklin H, Connor, Edward M, Sondheimer, Henry M, for the Cardiac Synagis Study Group
Format: Journal Article
Language:English
Published: New York, NY Mosby, Inc 01-10-2003
Elsevier
Subjects:
Antibodies, Monoclonal - therapeutic use
Antibodies, Monoclonal, Humanized
Antiviral Agents - therapeutic use
Biological and medical sciences
Comorbidity
Double-Blind Method
General aspects
Heart Defects, Congenital - epidemiology
Heart Defects, Congenital - surgery
Hospitalization - statistics & numerical data
Humans
Medical sciences
Palivizumab
Respiration, Artificial
Respiratory Syncytial Virus Infections - epidemiology
Respiratory Syncytial Virus Infections - prevention & control
Respiratory Syncytial Virus Infections - therapy
Risk Factors
RSV-IGIV
RSV
CHD
COSTART
Human
Human respiratory syncytial virus
Pediatrics
Pneumovirinae
Cardiovascular disease
Hospitalization
Respiratory system
Paramyxoviridae
Virus
Prevention
Respiratory tract
Mononegavirales
Chemotherapy
Palivizumab
Treatment
Pneumovirus
Congenital cardiopathy
Child
Online Access:Get full text
Tags: Add Tag
No Tags, Be the first to tag this record!
Description
Summary:To evaluate the safety, tolerance, and efficacy of palivizumab in children with hemodynamically significant congenital heart disease (CHD). 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. 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. 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.
Bibliography:ObjectType-Article-2
SourceType-Scholarly Journals-1
ObjectType-Feature-1
ObjectType-News-3
content type line 23
ISSN:0022-3476
1097-6833
DOI:10.1067/S0022-3476(03)00454-2