ABSTRACT
The two large multicenter studies that have produced conflicting results bear close scrutiny. In the first multicenter double-blind placebo-controlled study (28), 577 infants (of 588 randomized) who completed the protocol were analyzed. The infants weighed between 500 and 1750 g and were stratified in 250-g increments in birth weight. A lyophilized, highly purified preparation of IVIG obtained by Cohn fractionation and ion exchange adsorption was used (Gammagard, Baxter Healthcare, Hyland Division). Five hundred milligrams per kilogram body weight IVIG were given by slow infusion over a period of 30 min. The first dose was administered at 3-7 days of age, again at 1 week, and subsequently every 14 days for a total of five infusions or until discharge from the hospital. The control infants received 5 mg/kg albumin. Serum IgG levels were measured prior to each infusion and a week after the infusion (Fig. 3). lgG levels were comparable between groups prior to the infusions and steadily declined in the placebo group, while the trough Ig level at each point tested in the IVIG group was higher than the preinfusion level. There was a significantly lower incidence of infections in the IVIG group. The infusions were well tolerated by the patients. There was a significant reduction in the number of hospital days in the infants with infection. Coagulase-negative infections were the most frequent in the IVIG (34%) and in the control group (31 %).
