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Clinical Trial
. 1991;17(3-4):138-43.
doi: 10.1159/000457513.

Prevention of necrotizing enterocolitis in neonates at risk by oral administration of monomeric IgG

Affiliations
Clinical Trial

Prevention of necrotizing enterocolitis in neonates at risk by oral administration of monomeric IgG

F F Rubaltelli et al. Dev Pharmacol Ther. 1991.

Abstract

Necrotizing enterocolitis (NEC) represents one of the major causes of morbidity in low-birth-weight (LBW) preterm infants. This randomized clinical trial evaluated the efficacy of an oral immunoglobulin preparation (containing monomeric IgG in a concentration of 90%) in reducing the incidence of NEC in infants of LBW for whom maternal breast milk was not available. One hundred and thirty-two formula-fed newborns with a birth weight less than or equal to 1,500 g or a gestational age less than or equal to 34 weeks were randomly studied. Five hundred mg of IgG pro die, subdivided into 5 doses, were given orally to the test group of 65 neonates during the first 2 weeks of life. Although the number of infants included in this group is limited, the results of this study are encouraging: during the first 15 days after birth, none of the subjects developed NEC, while 4 cases were confirmed in the untreated control group. It, therefore, seems possible that oral monomeric IgG administration may prevent the development of NEC in LBW infants.

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