Intravenous gammaglobulin in the prophylaxis of late sepsis in very-low-birth-weight infants: preliminary results of a randomized, double-blind, placebo-controlled trial.

The efficacy of intravenous immunoglobulin (IVIG) as prophylaxis for late sepsis was evaluated in a placebo-controlled, randomized, double-blind trial involving 240 infants of very low birth weight (less than 1,300 g). Each infant received a total of five doses of either IVIG (1 g/d) or an albumin placebo. The first four doses were administered between days 1 and 5 of life, and the last dose was administered on day 15 or shortly thereafter. Preliminary analysis of data available for 126 patients showed that in the first 30 days, sepsis developed in nine of 61 patients given IVIG and in 16 of 65 given placebo (one-tailed P = .065). At 70 days, the number who developed sepsis was similar in the two groups: 20 for those who received IVIG vs. 23 for those who received placebo. When patients with coagulase-negative staphylococcal infections were deleted from the totals, the results were essentially the same, i.e., three of 61 who received IVIG vs. nine of 65 who received placebo (one-tailed P = .041), developed sepsis during the first 30 days and 12 of 61 vs. 13 of 65, respectively, had developed sepsis at 70 days. In the IVIG group, the median peak level of serum IgG at day 7 was 1,700 mg/dL and the IgG levels were significantly greater than those in the placebo group for days 7-42. These data suggest that infusions of IVIG at the doses and dosing intervals used in this study may be effective in decreasing the incidence of late-onset sepsis during the first month of life in infants of very low birth weight.