Objective. To determine the safety and efficacy of monthly prophylaxis with respiratory syncytial virus immune globulin, intravenous (RSV-IGIV) for reduction of the incidence of RSV-associated hospitalization.

Methods. A randomized, double-blind, placebo-controlled clinical trial was conducted at 54 centers in the United States during the 1994 to 1995 RSV season. A total of 510 children with bronchopulmonary dysplasia and/or a history of prematurity were randomized to receive either 750 mg/kg RSV-IGIV (n = 250) or placebo (1% albumin; n = 260) intravenously every 30 days. Randomized groups were well balanced at entry for demographics, RSV risk factors, and birth characteristics. Children were monitored for adverse events and for RSV-associated hospitalization from randomization through 30 days after the last infusion visit; serious adverse events were monitored for an additional 30 days. For children hospitalized with RSV, data were collected regarding the total days of RSV stay, total days of increased oxygen requirement, total days with a moderate or severe lower respiratory tract illness, and frequency and duration of intensive care unit stay and mechanical ventilation. Ninety-five percent of participants completed the protocol and 85% received a complete course of infusions.

Results. The incidence of RSV hospitalization was reduced by 41% in children receiving RSV-IGIV prophylaxis; 35 (13.5%) of the children in the placebo group were hospitalized for RSV, compared with 20 (8.0%) RSV-IGIV recipients. RSV-IGIV recipients had a 53% reduction in the total number of RSV hospital days per 100 children, a 60% reduction in the number of RSV days with increased oxygen requirement, and a 54% reduction in the number of RSV hospital days with a moderate or severe lower respiratory tract illness. In addition, children receiving RSV-IGIV had a 38% reduction in hospitalization for respiratory illness of any cause and a 46% reduction in total hospital days for respiratory illness per 100 children. RSV-IGIV was safe and well tolerated, with a safety profile similar to other IGIV preparations. Between 1% to 3% of children had medically significant adverse events related to RSV-IGIV administration.

Conclusions. Monthly administration of 750 mg/kg of RSV-IGIV was safe and well tolerated and was effective in reducing the incidence and total days of both RSV hospitalization and overall respiratory hospitalization in infants with a history of prematurity or bronchopulmonary dysplasia or both.

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