Infants with cardiopulmonary disease develop severe illness from respiratory syncytial virus (RSV) infection. Safety, feasibility, and pharmacokinetics of intravenous gamma globulin (IVIG) to prevent RSV illness were studied in 23 high-risk infants in a phase I trial. IVIG with an RSV neutralizing antibody titer of 1:1,100 in 5% solution was given monthly over a 2-to 4-h period in a clinical setting during the RSV season. The first group (n = 7) received 500 mg/kg of body weight, the second group (n = 9) received 600 mg/kg, and the third group (n = 7) received 750 mg/kg. Serum was drawn prior to infusion and 2, 14, and 30 days after infusion. Total immunoglobulin G and RSV A2 and RSV neutralizing antibody levels were obtained after the first IVIG infusion. Two children developed mild reversible pulmonary edema (group receiving 600 mg/kg per dose), and one developed hives and wheezing during one infusion (group receiving 500 mg/kg per dose). Twelve children developed subsequent RSV infection during two RSV seasons (November to April) over a 2-year follow-up period; 9 of 12 developed infection during the infusion year. Eleven illnesses were mild; one child died of progressive RSV illness (group receiving 500 mg/kg per dose). A cumulative infusion effect was not observed. IVIG appears safe and feasible in an outpatient setting, and at 750 mg/kg per dose, a target RSV antibody level of 21:100 was achieved.Respiratory syncytial virus (RSV) is the most common cause of serious respiratory illness in young children (2, 8). Children at greatest risk of serious or fatal RSV lower respiratory tract illness include those with bronchopulmonary dysplasia and congenital heart disease (10-12, 21, 22). Because the level of morbidity is so great in these populations, prevention of serious RSV lower respiratory tract illness is an important goal.It is unlikely that a live vaccine will be available in the near future to prevent high-risk young children from developing serious RSV infection. Vaccine development is proceeding cautiously because of the problem in developing a live vaccine which is safe, stable, and immunogenic and to avoid the serious pulmonary complications seen 20 years ago with the use of a formalin-inactivated vaccine (18