Neonatal sepsis is a major cause of death and complications despite antibiotic treatment. Newborn infants are relatively deficient in endogenous immunoglobulin. Polyvalent IgG immune globulin may help to prevent or treat infection, particularly in preterm infants, who have low serum IgG levels. Meta-analyses of trials of intravenous immune globulin for suspected or proven neonatal sepsis suggest a reduced rate of death from any cause, but the trials have been small and have varied in quality.

This study conducted at 113 hospitals in 9 countries enrolled 3493 infants receiving antibiotics for suspected or proven serious infection. They were randomised to receive two infusions of either polyvalent IgG immune globulin (500mg/kg) or matching placebo 48 hours apart. The primary outcome was death or major disability at the age of 2 years.

The following findings were reported:

• There was no significant between-group difference in the rates of the primary outcome, which occurred in 686 of 1759 infants (39.0%) on intravenous immune globulin and in 677 of 1734 infants (39.0%) on placebo (relative risk, 1.00; 95% CI, 0.92 to 1.08).

• There were no significant differences in the rates of secondary outcomes, including the incidence of subsequent sepsis episodes.

• In follow-up of 2-year-old infants, there were no significant differences in the rates of major or non-major disability or of adverse events.

The researchers conclude from these findings that “these results clearly show that intravenous immune globulin, as prescribed in this trial, did not achieve the moderate improvements in outcome that were postulated. A larger trial would be necessary to show even smaller differences.”