Safety and efficacy of intravenous immunoglobulin prophylaxis in pediatric head trauma patients: a double-blind controlled trial.

Infection is one of the major complications of severe head trauma in children. To assess whether intravenous immunoglobulin (IVIg) decreases the incidence of secondary infection after head injury in children, a randomized, double-blind trial was performed. Thirty-three children (mean age, 6.67 years; mean injury severity score, 32.8; mean Glasgow coma score, 6.1) with severe head injuries were enrolled; 1 child was excluded, 18 received IVIg, and 14 received the placebo preparation. Four hundred milligrams per kilogram of IVIg or albumin placebo was administered within 48 hours of admission. IgG levels were obtained before the infusion and then 1 week later. Patients were monitored for evidence of infection for the next 21 days. There was a 66% increase in mean IgG levels in the treatment group compared with 45% in the control group (P = .057). One death occurred in the IVIg group and two in the placebo group. No significant differences in the incidence of pneumonia, sepsis, presumed sepsis, or any other type of infection was noted. There was no difference in the number of days on mechanical ventilation or in number of hospital days. There were no side effects. It is concluded that prophylactic administration of commercial IVIg at a dose of 400 mg/kg, although safe, had no effect on the incidence of secondary infections in children with severe head injuries.