Nonsignificant differences seen for outcomes with immune globulin and placebo in neonatal sepsis
WEDNESDAY, Sept. 28 (HealthDay News) -- Infants with suspected or proven sepsis treated with intravenous immune globulin have no significant difference in outcomes compared to those receiving a placebo, according to a study published in the Sept. 29 issue of the New England Journal of Medicine.
Peter Brocklehurst, M.B., Ch.B., from the University of Oxford in the United Kingdom, and colleagues from the International Neonatal Immunotherapy Study Collaborative Group examined the efficacy of adjunctive therapy with immune globulin in 3,493 newborn infants receiving antibiotics for suspected or proven sepsis. A total of 1,759 infants received two infusions of human nonspecific polyvalent immunoglobulin G immune globulin (500 mg per kilogram of body weight) and 1,734 received a matching placebo 48 hours apart. Death or major disability at the age of 2 years was the primary outcome.
The investigators identified no significant difference in the primary outcome rates between the groups (39 percent each for those receiving immune globulin or placebo). The differences in the incidence of subsequent sepsis episodes and other secondary outcomes were also found to be nonsignificant. No significant differences were observed in the rates of major or non-major disability or adverse events in the follow-up of 2-year-old infants.
"Therapy with intravenous immune globulin had no effect on the outcomes of suspected or proven neonatal sepsis," the authors write.
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