title: Enteral human IgG for prevention of necrotising enterocolitis: a placebo-controlled, randomised trial.
abstract: BACKGROUND
  Neonatal necrotising enterocolitis is a serious, commonly fatal disease in premature neonates. Although feeding with expressed breast milk and other good nursery practices are partly protective, preventive measures are needed. Treating neonates enterally with a mixture of human IgA and IgG, prepared from donated blood, has been claimed to protect against necrotising enterocolitis. However, no IgA preparation is available in Australia. Our aim, therefore, was to identify whether or not enteral IgG could prevent the disorder.
  
  
  METHODS
  We did a multicentre, double-blind, placebo- controlled trial. We randomly assigned 768 infants to receive human IgG 1200 mg/kg daily, and 761 to receive placebo, for up to 28 days. Treatment began at the same time as enteral feeding. The primary outcome measure was the proportion of infants who developed definite necrotising enterocolitis during the trial, and any deaths that resulted from the disorder in the treatment and placebo groups. Analysis was on an intention-to-treat basis.
  
  
  RESULTS
  43 infants developed definite necrotising enterocolitis in the IgG group, ten of whom died. In the placebo group, 41 infants contracted the disorder and six died (p=0.47). 25 infants on IgG and 36 on placebo had suspect necrotising enterocolitis (p=0.14).
  
  
  CONCLUSIONS
  Supplementation of enteral feeds with human IgG does not reduce necrotising enterocolitis.
authors.affiliation: Queensland Institute of Medical Research, PO Royal Brisbane Hospital, 4029, Brisbane, Australia. gregL@QIMR.edu.au
authors.forename: G
authors.initials: G
authors.lastname: Lawrence
authors.forename: D
authors.initials: D
authors.lastname: Tudehope
authors.forename: K
authors.initials: K
authors.lastname: Baumann
authors.forename: H
authors.initials: H
authors.lastname: Jeffery
authors.forename: A
authors.initials: A
authors.lastname: Gill
authors.forename: M
authors.initials: M
authors.lastname: Cole
authors.forename: J
authors.initials: J
authors.lastname: Drew
authors.forename: A
authors.initials: A
authors.lastname: McPhee
authors.forename: J
authors.initials: J
authors.lastname: Ratcliffe
authors.forename: G
authors.initials: G
authors.lastname: Reynolds
authors.forename: J
authors.initials: J
authors.lastname: Simes
authors.forename: C
authors.initials: C
authors.lastname: Swanson
authors.forename: D
authors.initials: D
authors.lastname: Cartwright
authors.forename: P
authors.initials: P
authors.lastname: Davis
authors.forename: I
authors.initials: I
authors.lastname: Humphrey
authors.forename: A
authors.initials: A
authors.lastname: Berry
mesh_terms: D004311:Double-Blind Method; D004750:Enteral Nutrition; D020345:Enterocolitis, Necrotizing / Q000453:epidemiology / Q000517:prevention & control*; D005260:Female; D006801:Humans; D007074:Immunoglobulin G / Q000008:administration & dosage / Q000627:therapeutic use*; D007227:Infant Nutritional Physiological Phenomena; D007231:Infant, Newborn; D007234:Infant, Premature; D007235:Infant, Premature, Diseases / Q000453:epidemiology / Q000517:prevention & control*; D016015:Logistic Models; D008297:Male; D012307:Risk Factors
chemical_list: D007074:Immunoglobulin G