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Neonatal sepsis continues to be associated with significant morbidity and mortality, even with appropriate antibiotic management and excellent supportive care. Intravenous immune globulin (IVIG) has been examined as a potential adjunctive therapy, but its use remains controversial because results from small studies have been inconsistent, some showing benefit and some not. In a large international collaborative study, investigators randomized 3493 infants who were receiving antibiotics for proven or suspected sepsis to receive two infusions of IVIG (500 mg/kg/day) or placebo separated by 48 hours.
Among the 3378 infants included in the follow-up analysis, the incidence of death or major disability at 2 years (the primary outcome measure) was…