Journal of critical care
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Journal of critical care · Dec 1993
Randomized Controlled Trial Clinical TrialSafety 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. ⋯ 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.