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

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.

RCT Entities:   Population Interventions Outcomes