Respiratory syncytial virus immune globulin for prophylaxis against respiratory syncytial virus disease in infants and children with congenital heart disease. The Cardiac Study Group.

Abstract

OBJECTIVE:

To examine the effectiveness of respiratory syncytial virus immune globulin administered intravenously (RSV-IGIV) in reducing hospitalization for treatment of RSV in children with congenital heart disease (CHD).

METHODS:

Children younger than 4 years of age were randomly assigned to a treatment group receiving RSV-IGIV, 750 mg/kg, monthly or to a control group not receiving infusions. Surveillance for respiratory tract infections was carried out and management decisions were made by physicians blinded to treatment group.

RESULTS:

Hospitalization for treatment of an RSV infection occurred in 32 of 214 (15%) of control children and 21 of 202 (10%) of the children receiving RSV-IGIV, a 31% reduction (P = .16). However, in infants younger than 6 months of age at study entry, 20 of 82 (24%) in the control group and 10 of 96 (10%) in the RSV-IGIV group had RSV hospitalizations (58% reduction, P = .01). The incidence of hospitalization for any respiratory tract symptomatology was lower in the RSV-IGIV group (34 of 202, 17%) than in the control group (57 of 214, 27%; P = .02). There was a significantly higher frequency of unanticipated cyanotic episodes and of poor outcomes after surgery among children with cyanotic CHD in the RSV-IGIV group (22 of 78, 28%) than in the control group (4 of 47, 8.5%; P = .009).

CONCLUSION:

RSV-IGIV should not be used for prophylaxis of RSV disease in children with cyanotic CHD. RSV-IGIV did not reduce RSV hospitalization in all children with CHD, but it was effective in preventing RSV hospitalization in infants younger than 6 months of age. Further studies in these children are indicated.

• Authors: E A Simoes, H M Sondheimer, F H Top Jr, H C Meissner, R C Welliver, A A Kramer, J R Groothuis
• Journal: The Journal of pediatrics (J Pediatr) Vol. 133 Issue 4 Pg. 492-9 (Oct 1998) ISSN: 0022-3476 [Print] United States
• PMID: 9787686 (Publication Type: Clinical Trial, Comparative Study, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't, Research Support, U.S. Gov't, P.H.S.)

Chemical References

• Immunoglobulins, Intravenous
• respiratory syncytial virus immune globulin intravenous

Topics

• Age Factors
• Child, Preschool
• Cyanosis (complications)
• Heart Defects, Congenital (complications)
• Humans
• Immunoglobulins, Intravenous (therapeutic use)
• Infant
• Intensive Care Units, Pediatric
• Prospective Studies
• Respiratory Syncytial Virus Infections (complications, prevention & control, rehabilitation)
• Respiratory Syncytial Viruses
• Single-Blind Method