RESPIRATORY SYNCYTIAL VIRUS IMMUNE GLOBULIN FOR PROPHYLAXIS AGAINST RESPIRATORY SYNCYTIAL VIRUS-DISEASE IN INFANTS AND CHILDREN WITH CONGENITAL HEART-DISEASE

Objective: To examine the effectiveness of respiratory syncytial virus immune globulin administered intravenously (RSV-IGIV) in reducing hos pitalization for treatment of RSV in children with congenital heart di sease (CHD). Methods: Children younger than 4 years of age were random ly assigned to a treatment group receiving RSV-IGIV, 750 mg/kg, monthl y or to a control group not receiving infusions. Surveillance for resp iratory tract infections was carried out and management decisions were made by physicians blinded to treatment group. Results: Hospitalizati on for treatment of an RSV infection occurred in 32 of 214 (15%) of co ntrol 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 9 6 (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 i n the control group (57 of 214, 27%; P = .02). There was a significant ly higher frequency of unanticipated cyanotic episodes and of poor out comes after surgery among children with cyanotic CHD in the RSV-IGIV g roup (22 of 78, 28%) than in the control group (4 of 47, 8.5%; P = .00 9). Conclusion: RSV-IGIV should not be used for prophylaxis of RSV dis ease in children with cyanotic CHD. RSV-IGIV did not reduce RSV hospit alization 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.