Abstract | BACKGROUND: 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 | Brenda B Poindexter, Richard A Ehrenkranz, Barbara J Stoll, Linda L Wright, W Kenneth Poole, William Oh, Charles R Bauer, Lu-Ann Papile, Jon E Tyson, Waldemar A Carlo, Abbot R Laptook, Vivek Narendran, David K Stevenson, Avroy A Fanaroff, Sheldon B Korones, Seetha Shankaran, Neil N Finer, James A Lemons, National Institute of Child Health and Human Development Neonatal Research Network |
Journal | Pediatrics
(Pediatrics)
Vol. 113
Issue 5
Pg. 1209-15
(May 2004)
ISSN: 1098-4275 [Electronic] United States |
PMID | 15121931
(Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, U.S. Gov't, P.H.S.)
|
Chemical References |
|
Topics |
- Dietary Supplements
- Double-Blind Method
- Female
- Glutamine
(administration & dosage)
- Humans
- Infant Mortality
- Infant, Newborn
- Infant, Premature
- Infant, Very Low Birth Weight
- Male
- Parenteral Nutrition
- Sepsis
(epidemiology, prevention & control)
- Survival Analysis
|