Multicenter Study to Assess Safety and Efficacy of INH-A21, a Donor-Selected Human Staphylococcal Immunoglobulin, for Prevention of Nosocomial Infections in Very Low Birth Weight Infants

Abstract

INH-A21 750 mg/kg demonstrated potential to reduce sepsis caused by S. aureus, candidemia and mortality in VLBW infants. Although statistical significance was not reached, based on the magnitude of the estimated differences, the efficacy and safety of INH-A21 750 mg/kg should be evaluated in an adequately powered, well-controlled study.