title: Parenteral glutamine supplementation does not reduce the risk of mortality or late-onset sepsis in extremely low birth weight infants.
abstract: BACKGROUND
  Glutamine is one of the most abundant amino acids in both plasma and human milk, yet it is not included in standard intravenous amino acid solutions. Previous studies have suggested that parenteral nutrition (PN) supplemented with glutamine may reduce sepsis and mortality in critically ill adults. Whether glutamine supplementation would provide a similar benefit to extremely low birth weight (ELBW) infants is not known.
  
  
  METHODS
  We performed a multicenter, randomized, double-masked, clinical trial to assess the safety and efficacy of early PN supplemented with glutamine in decreasing the risk of death or late-onset sepsis in ELBW infants. Infants 401 to 1000 g were randomized within 72 hours of birth to receive either TrophAmine (control) or an isonitrogenous study amino acid solution with 20% glutamine whenever they received PN up to 120 days of age, death, or discharge from the hospital. The primary outcome was death or late-onset sepsis.
  
  
  RESULTS
  Of the 721 infants who were assigned to glutamine supplementation, 370 (51%) died or developed late-onset sepsis, as compared with 343 of the 712 infants (48%) assigned to control (relative risk: 1.07; 95% confidence interval: 0.97-1.17). Glutamine had no effect on tolerance of enteral feeds, necrotizing enterocolitis, or growth. No significant adverse events were observed with glutamine supplementation.
  
  
  CONCLUSIONS
  Parenteral glutamine supplementation as studied did not decrease mortality or the incidence of late-onset sepsis in ELBW infants. Consequently, although no harm was demonstrated, routine use of parenteral glutamine supplementation cannot be recommended in this population.
authors.affiliation: Department of Pediatrics, Indiana University School of Medicine, Indianapolis, Indiana, USA. bpoindex@iupui.edu
authors.forename: Brenda B
authors.initials: BB
authors.lastname: Poindexter
authors.forename: Richard A
authors.initials: RA
authors.lastname: Ehrenkranz
authors.forename: Barbara J
authors.initials: BJ
authors.lastname: Stoll
authors.forename: Linda L
authors.initials: LL
authors.lastname: Wright
authors.forename: W Kenneth
authors.initials: WK
authors.lastname: Poole
authors.forename: William
authors.initials: W
authors.lastname: Oh
authors.forename: Charles R
authors.initials: CR
authors.lastname: Bauer
authors.forename: Lu-Ann
authors.initials: LA
authors.lastname: Papile
authors.forename: Jon E
authors.initials: JE
authors.lastname: Tyson
authors.forename: Waldemar A
authors.initials: WA
authors.lastname: Carlo
authors.forename: Abbot R
authors.initials: AR
authors.lastname: Laptook
authors.forename: Vivek
authors.initials: V
authors.lastname: Narendran
authors.forename: David K
authors.initials: DK
authors.lastname: Stevenson
authors.forename: Avroy A
authors.initials: AA
authors.lastname: Fanaroff
authors.forename: Sheldon B
authors.initials: SB
authors.lastname: Korones
authors.forename: Seetha
authors.initials: S
authors.lastname: Shankaran
authors.forename: Neil N
authors.initials: NN
authors.lastname: Finer
authors.forename: James A
authors.initials: JA
authors.lastname: Lemons
mesh_terms: D019587:Dietary Supplements; D004311:Double-Blind Method; D005260:Female; D005973:Glutamine / Q000008:administration & dosage*; D006801:Humans; D007226:Infant Mortality; D007231:Infant, Newborn; D007234:Infant, Premature; D019102:Infant, Very Low Birth Weight; D008297:Male; D010288:Parenteral Nutrition; D018805:Sepsis / Q000453:epidemiology / Q000517:prevention & control*; D016019:Survival Analysis
chemical_list: D005973:Glutamine