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J Pediatr ; 151(3): 260-5, 265.e1, 2007 Sep.
Article in English | MEDLINE | ID: mdl-17719934

ABSTRACT

OBJECTIVE: To determine if INH-A21, an intravenous immune globulin (IGIV) derived from donors with high titers of antibody to surface adhesins of Staphylococcus epidermidis and S. aureus prevents late-onset sepsis (LOS) in very low birth weight (VLBW) infants. STUDY DESIGN: In this double-blind, placebo-controlled study, infants with birth weights 500 to 1250 g were randomized to receive up to four doses of INH-A21 (Veronate) or placebo. The primary objective was to determine the safety and efficacy of INH-A21 versus placebo for prevention of S. aureus LOS in VLBW infants. RESULTS: A total of 1983 infants from 95 neonatal intensive care units were randomized, and received at least one dose of study drug. S. aureus LOS developed in 50 of 989 (5%) and 60 of 994 (6%) infants who received placebo or INH-A21, respectively (P = .34). No differences were found in the frequencies of LOS caused by coagulase-negative staphylococci (CoNS), Candida spp, or overall mortality. No adverse events were statistically significantly associated with INH-A21 infusions compared with placebo. CONCLUSION: INH-A21 failed to reduce the incidence of staphylococcal LOS or candidemia in premature infants.


Subject(s)
Cross Infection/prevention & control , Immunoglobulins, Intravenous/therapeutic use , Immunologic Factors/therapeutic use , Infant, Premature, Diseases/prevention & control , Sepsis/microbiology , Sepsis/prevention & control , Staphylococcal Infections/prevention & control , Age of Onset , Comorbidity , Double-Blind Method , Female , Humans , Infant, Newborn , Infant, Premature , Infant, Very Low Birth Weight , Length of Stay , Male , Sepsis/epidemiology , Time Factors
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