PEDIATRICS Vol. 88 No. 3 September 1991, pp. 437-443
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Intravenous Immunoglobulin Therapy for Prevention of Infection in High-Risk Premature Infants: Report of a Multicenter, Double-Blind Study

Jean-François Magny MD1, Clothilde Bremard-Oury 2, Dominique Brault MD3, Claudie Menguy MD4, Marcel Voyer MD5, Paul Landais MD6, Michel Dehan MD1, and Jean-Claude Gabilan MD1

1 The newborn intensive care units of Clamart Hospital
2 The French Blood Transfusion National Center
3 The newborn intensive care units of Créteil Hospital
4 The newborn intensive care units of Montreuil Hospital
5 The newborn intensive care units of Institute of Puériculture of Paris
6 The Biostatistics Department, Necker Hospital, Paris, France

The effectiveness of intravenously administered immunoglobulin (Ig) therapy for prophylaxis of infection was evaluated in high-risk preterm infants. Two hundred thirty-five premature newborns were randomly assigned, in a double-blind controlled trial, to treatment and placebo groups. Thirty-five infants (29%) of the Ig group and 29 (25%) of the placebo group had one or more episodes of certain infection. Thirty infants (25%) of the Ig group and 18 (16%) of the placebo group had one or more episodes of probable infection. No significant differences were observed in the incidence of certain or probable infection in treated and control infants. Nevertheless, among the infants who had one or more certain or probable episodes of infection, more of them belonged to the Ig group than to the placebo group. The possible deleterious effect of the administration of large amounts of polyspecific Ig is discussed.

Key Words: immunoglobulins • infection • premature neonate • passive immunization

Submitted on July 9, 1990
Accepted on November 28, 1990




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