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.
Intravenous immunoglobulin for prevention of sepsis in preterm and low birth weight infants.
The effect of an intravenous polyvalent immunoglobulin preparation given prophylactically to prevent neonatal sepsis was tested in preterm and low birth weight infants. Infants matched for gestational age, sex and birth weight (+/- 250 g) were randomly allocated into 3 groups of 50 each, one group (Group C) being used as control. Group A received Intraglobulin (Biotest Pharma, West Germany), 120 mg/kg intravenously, within 2 to 4 hours of delivery; Group B received the same on days 1 and 8. The control group received no immunoglobulin. The frequency of infection and serum immunoglobulin concentrations were determined in each group. Infection rate in the control group was 16% (8 of 50) while in each of the treated groups it was 4% (2 of 50) (P less than 0.005). The immunoglobulin concentrations achieved in the treated group were significantly higher than the control group. No adverse effect of the therapy was noted during the study and at a 6-month follow-up. It is suggested that in nurseries where the infection rate is high, prophylactic intravenous polyvalent immunoglobulin therapy for the preterm and low birth weight infants may provide protection from infection.