PROPHYLACTIC ADMINISTRATION OF RESPIRATORY SYNCYTIAL VIRUS IMMUNE GLOBULIN TO HIGH-RISK INFANTS AND YOUNG-CHILDREN

Background. Infants with cardiac disease or prematurity are at risk fo r severe illness caused by respiratory syncytial virus. Immune globuli n with a high titer of antibodies against respiratory syncytial virus may offer infants and young children at risk protection from this seri ous, common respiratory illness.Methods. We studied 249 infants and yo ung children (mean age, eight months) who had bronchopulmonary dysplas ia due to prematurity (n = 102), congenital heart disease (n = 87), or prematurity alone (n = 60). Respiratory syncytial virus immune globul in was given monthly to some of these children in either a high dose ( 750 mg per kilogram of body weight; n = 81) or a low dose (150 mg per kilogram; n = 79); 89 controls received no immune globulin. Group assi gnments were random. Assessments of respiratory illness and management were conducted without knowledge of the children's group assignments. Results. There were 64 episodes of respiratory syncytial virus infect ion: 19 in the high-dose group, 16 in the low-dose group, and 29 in th e control group. In the high-dose group there were fewer lower respira tory tract infections (7, vs. 20 in the control group; P = 0.01), fewe r hospitalizations (6, vs. 18 in the control group; P = 0.02), fewer h ospital days (43, vs. 128 in the control group; P = 0.02), fewer days in the intensive care unit (P = 0.05), and less use of ribavirin (P = 0.05). In the low-dose group there was a significant reduction only in the number of days in the intensive care unit (P = 0.03). Adverse eve nts during the 580 infusions were generally mild and included fluid ov erload (in five children), oxygen desaturation (eight), and fever (six ). Six children died: three in the high-dose group, three in the low-d ose group, and none in the control group (P = 0.15), but no death was attributed to the use of immune globulin or to illness caused by respi ratory syncytial virus. Conclusions. Administration of high doses of r espiratory syncytial virus immune globulin is a safe and effective mea ns of preventing lower respiratory tract infection in infants and youn g children at high risk for this disease.