title: Treatment of neonatal sepsis with intravenous immune globulin.
abstract: BACKGROUND
  Neonatal sepsis is a major cause of death and complications despite antibiotic treatment. Effective adjunctive treatments are needed. Newborn infants are relatively deficient in endogenous immunoglobulin. Meta-analyses of trials of intravenous immune globulin for suspected or proven neonatal sepsis suggest a reduced rate of death from any cause, but the trials have been small and have varied in quality.
  
  
  METHODS
  At 113 hospitals in nine countries, we enrolled 3493 infants receiving antibiotics for suspected or proven serious infection and randomly assigned them to receive two infusions of either polyvalent IgG immune globulin (at a dose of 500 mg per kilogram of body weight) or matching placebo 48 hours apart. The primary outcome was death or major disability at the age of 2 years.
  
  
  RESULTS
  There was no significant between-group difference in the rates of the primary outcome, which occurred in 686 of 1759 infants (39.0%) who received intravenous immune globulin and in 677 of 1734 infants (39.0%) who received placebo (relative risk, 1.00; 95% confidence interval, 0.92 to 1.08). Similarly, there were no significant differences in the rates of secondary outcomes, including the incidence of subsequent sepsis episodes. In follow-up of 2-year-old infants, there were no significant differences in the rates of major or nonmajor disability or of adverse events.
  
  
  CONCLUSIONS
  Therapy with intravenous immune globulin had no effect on the outcomes of suspected or proven neonatal sepsis.
authors.affiliation: National Perinatal Epidemiology Unit, University of Oxford, Old Road Campus, Headington, Oxford OX3 7LF, United Kingdom.
authors.forename: Peter
authors.initials: P
authors.lastname: Brocklehurst
authors.forename: Barbara
authors.initials: B
authors.lastname: Farrell
authors.forename: Andrew
authors.initials: A
authors.lastname: King
authors.forename: Edmund
authors.initials: E
authors.lastname: Juszczak
authors.forename: Brian
authors.initials: B
authors.lastname: Darlow
authors.forename: Khalid
authors.initials: K
authors.lastname: Haque
authors.forename: Alison
authors.initials: A
authors.lastname: Salt
authors.forename: Ben
authors.initials: B
authors.lastname: Stenson
authors.forename: William
authors.initials: W
authors.lastname: Tarnow-Mordi
mesh_terms: D000900:Anti-Bacterial Agents / Q000627:therapeutic use; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D016908:Gram-Positive Bacterial Infections / Q000188:drug therapy; D006801:Humans; D016756:Immunoglobulins, Intravenous / Q000627:therapeutic use*; D007155:Immunologic Factors / Q000627:therapeutic use*; D007231:Infant, Newborn; D008297:Male; D012306:Risk; D055502:Secondary Prevention; D018805:Sepsis / Q000188:drug therapy*; D013203:Staphylococcal Infections / Q000188:drug therapy
chemical_list: D000900:Anti-Bacterial Agents; D016756:Immunoglobulins, Intravenous; D007155:Immunologic Factors