IVIG administration results in a 3% reduction in sepsis and a 4% reduction in one or more episodes of any serious infection but is not associated with reductions in other clinically important outcomes, including mortality. Prophylactic use of IVIG is not associated with any short-term serious side effects.
The decision to use prophylactic IVIG will depend on the costs and the values assigned to the clinical outcomes. There is no justification for conducting additional RCTs to test the efficacy of previously studied IVIG preparations in reducing nosocomial infections in preterm and/or LBW infants.
The use of intravenous gamma-globulin for prevention of sepsis in pre-term infants. A controlled clinical trial.
This paper reports a randomized clinical trial to study the effect of an intravenous gamma-globulin preparation to prevent sepsis in pre-term newborn infants. 80 infants were enrolled: 37 of birthweight less than or equal to 1500 g and 43 of birthweight 1501-2000 g. In each group 20 infants received an intravenous preparation of gamma-globulin (0.5 g/kg/wk); the remaining 17 and 20, respectively, served as control cases. No significant differences in the occurrence of sepsis were observed between the group receiving prophylactively intravenous gamma-globulin and the control group. This is particularly evident in infants under intensive care (35% of the total population): in this group 2/3 of sepsis occurred in infants who received IgG. Among the infants with sepsis, the presence of an umbilical artery catheterization represented a significant risk-factor. The post-dose increment of serum IgG did not differ significantly in infants with and without sepsis; the post-dose serum disappearance rate in concentration appears identical in the two groups.