title: 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).
  
  
  CONCLUSIONS
  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.affiliation: University of Colorado, Denver, USA.
authors.forename: E A
authors.initials: EA
authors.lastname: Simoes
authors.forename: H M
authors.initials: HM
authors.lastname: Sondheimer
authors.forename: F H
authors.initials: FH
authors.lastname: Top
authors.forename: H C
authors.initials: HC
authors.lastname: Meissner
authors.forename: R C
authors.initials: RC
authors.lastname: Welliver
authors.forename: A A
authors.initials: AA
authors.lastname: Kramer
authors.forename: J R
authors.initials: JR
authors.lastname: Groothuis
mesh_terms: D000367:Age Factors; D002675:Child, Preschool; D003490:Cyanosis / Q000150:complications; D006330:Heart Defects, Congenital / Q000150:complications*; D006801:Humans; D016756:Immunoglobulins, Intravenous / Q000627:therapeutic use*; D007223:Infant; D015278:Intensive Care Units, Pediatric; D011446:Prospective Studies; D018357:Respiratory Syncytial Virus Infections / Q000150:complications* / Q000517:prevention & control* / Q000534:rehabilitation; D012136:Respiratory Syncytial Viruses; D016037:Single-Blind Method
chemical_list: D016756:Immunoglobulins, Intravenous; C098685:respiratory syncytial virus immune globulin intravenous