title: Intravenous immune globulin prophylaxis of late-onset sepsis in premature neonates.
abstract: To determine whether a single dose of intravenously administered immune globulin (IVIG) decreases late-onset sepsis in premature infants, we prospectively entered 753 neonates with birth weight 500 to 2000 gm, gestation < or = 34 weeks, and age < or = 12 hours into a multicenter, double-blind, controlled trial. Infants were randomly selected to receive a single intravenous infusion, 10 ml/kg, of either IVIG (500 mg/kg) or albumin (5 mg/kg) and were observed for 8 weeks for infection. Maternal and neonatal risk factors for infection did not differ between groups. Although serum IgG values before infusion were related to gestation (R = 0.62), the change in serum IgG or half-life of IgG after IVIG infusion was not (R < or = 0.09). The serum IgG concentration was increased (p < 0.05) in IVIG-treated patients for 8 weeks. There were 88 episodes of late-onset sepsis in 79 neonates (10.5%). Causative organisms included the following: Staphylococcus epidermidis (37 episodes), Enterococcus (9), Staphylococcus aureus (7), Candida (6), Escherichia coli (6), and multiple organisms (11). Sepsis, death, and death as a result of infection were unaffected by treatment. We conclude that a single infusion of IVIG, 500 mg/kg, shortly after birth was not effective prophylaxis for late-onset infection in premature neonates. Future studies of late-onset sepsis prophylaxis should consider IVIG with known pathogen-specific antibody concentrations against organisms causing these infections, in particular S. epidermidis.
authors.affiliation: Department of Pediatrics, Uniformed Services University of the Health Sciences, Bethesda, Maryland.
authors.forename: L E
authors.initials: LE
authors.lastname: Weisman
authors.forename: B J
authors.initials: BJ
authors.lastname: Stoll
authors.forename: T J
authors.initials: TJ
authors.lastname: Kueser
authors.forename: T T
authors.initials: TT
authors.lastname: Rubio
authors.forename: C G
authors.initials: CG
authors.lastname: Frank
authors.forename: H S
authors.initials: HS
authors.lastname: Heiman
authors.forename: K N
authors.initials: KN
authors.lastname: Subramanian
authors.forename: C T
authors.initials: CT
authors.lastname: Hankins
authors.forename: D F
authors.initials: DF
authors.lastname: Cruess
authors.forename: V G
authors.initials: VG
authors.lastname: Hemming
mesh_terms: D000418:Albumins / Q000627:therapeutic use*; D016470:Bacteremia / Q000453:epidemiology / Q000382:microbiology / Q000517:prevention & control*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007074:Immunoglobulin G / Q000097:blood / Q000187:drug effects; D016756:Immunoglobulins, Intravenous / Q000627:therapeutic use*; D007231:Infant, Newborn; D007235:Infant, Premature, Diseases / Q000453:epidemiology / Q000382:microbiology / Q000517:prevention & control*; D007262:Infusions, Intravenous; D008297:Male; D012307:Risk Factors; D013997:Time Factors
chemical_list: D000418:Albumins; D007074:Immunoglobulin G; D016756:Immunoglobulins, Intravenous