Despite the presence in the arsenal of physicians of highly effective modern antimicrobials, sepsis in newborns is an important cause of death and the development of complications. In newborns, there is a relative deficiency of endogenous immunoglobulins. According to a meta-analysis of clinical studies that have examined the use of intravenous immunoglobulins in suspected or proven sepsis of newborns, a decrease in the frequency of death has been demonstrated for all reasons, but most studies included in the meta-analysis were small and of variable quality. Given the relatively high cost of intravenous immunoglobulins (treating a newborn with immunoglobulins costs about $ 1,200), it is advisable to establish the effectiveness of this therapeutic tactic in newborns.

The new study involved 3,493 newborn babies in 113 hospitals in 9 countries. All children received antibiotics for a suspected or proven serious infection and were randomly assigned to receive 2 infusions of polyvalent immunoglobulin (IgG) at a dose of 500 mg / kg or placebo at 48 hour intervals. The main endpoint was lethal outcome or significant health disturbance at the age of 2 years.

There were no significant intergroup differences in the incidence of primary outcomes recorded in 686 of 1,759 children (39%) who received immunoglobulins and 677 of 1,734 newborns (39%) who received placebo (relative risk 1.00, 95% confidence interval 0.92-1.08). At 2 years, 322 children (18.3%) in the immunoglobulin group and 306 children (17.6%) in the placebo group (95% confidence interval 0.9-1.2) were fatal. Although the development of cerebral palsy was not considered a predetermined outcome, there was no statistically significant difference in the frequency of this diagnosis at 2 years (122 children (8.5%) in the group immunoglobulin and 118 children (8.3%) in the placebo group).

There was also no difference in the incidence of secondary outcomes, including the incidence of subsequent septic episodes. During the 2-year follow-up period, no significant difference was observed in the frequency of significant health conditions or adverse events between the groups compared.

Thus, administration of an intravenous immunoglobulin does not affect the outcome in patients with suspected or proven sepsis of the newborn. This project is a good example when a sufficiently simple and sufficiently organized large-scale study can effectively refute ideas that have been obtained in less significant or lower quality studies.