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.
Prophylactic intravenous immunoglobulin in pre-term infants: a controlled trial.
Sixty-six pre-term infants of less than 30 weeks gestation consecutively admitted to either of two neonatal intensive care units were randomized to receive routine intensive care only or prophylactic intravenous immunoglobulin, 200 mg/kg body weight at 3-weekly intervals in addition to routine intensive care. Eleven babies, 6 in the control group and 5 in the treatment group, were withdrawn from the trial due to early death from extreme prematurity (7 babies), early return to the referring hospital (3 babies), and elective treatment with intravenous immunoglobulin for severe congenital septicaemia (1 baby). Of the 55 who remained in the trial, significantly fewer babies in the treatment group had infection, 8 compared to 17 (p = 0.01). This difference was not significant when blood-culture-proven septicaemia only was considered, 8 compared to 14 (p = 0.09). Twenty-seven (84%) of 32 blood-culture-positive episodes of infection were caused by coagulase-negative staphylococci. Serum IgG was significantly higher with treatment and achieved levels comparable to those of normal full-term babies at the same post-natal age.