PURPOSE OF THE STUDY.
Neonatal sepsis is a major cause of death and complications despite antibiotic treatment. Effective adjunctive treatments are needed. Newborn infants are relatively deficient in endogenous immunoglobulin. Meta-analyses of trials of intravenous immunoglobulin for suspected or proven neonatal sepsis suggest a reduced rate of death from any cause, but the trials have been small and of varied quality.
At 113 hospitals in 9 countries, 3493 infants receiving antibiotics for suspected or proven serious infection were enrolled.
Participants were randomly assigned to receive 2 infusions of either polyvalent immunoglobulin G (at a dose of 500 mg/kg of body weight) or placebo 48 hours apart. The primary outcome was death or major disability at age 2 years.
There was no significant between-group difference in the rates of the primary outcome, which occurred in 686 of 1759 infants (39.0%) who received intravenous immunoglobulin and in 677 of 1734 infants (39.0%) who received placebo (relative risk: 1.00 [95% confidence interval: 0.92–1.08]). Similarly, there were no significant differences in the rates of secondary outcomes, including the incidence of subsequent sepsis episodes. In the follow-up of 2-year-old infants, there were no significant differences in the rates of disability or of adverse events.
Therapy with intravenous immunoglobulin had no effect on the outcomes of suspected or proven neonatal sepsis.
This study should put to rest the question of whether antibody supplementation via serum immunoglobulin is useful in treating neonatal sepsis. This double-blind control study in a large group of neonates clearly demonstrated that this treatment is not an effective adjunctive therapy when added to antibiotic therapy.
- Copyright © 2012 by the American Academy of Pediatrics