Parenteral Glutamine Supplementation Does Not Reduce the Risk of Mortality or Late-Onset Sepsis in Extremely Low Birth Weight Infants

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

Research output: Contribution to journalArticle

136 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)1209-1215
Number of pages7
JournalPediatrics
Volume113
Issue number5 I
DOIs
StatePublished - May 1 2004

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Extremely Low Birth Weight Infant
Glutamine
Sepsis
Mortality
Parenteral Nutrition
Amino Acids
Necrotizing Enterocolitis
Human Milk
Critical Illness
Small Intestine

Keywords

  • Extremely low birth weight infants
  • Glutamine
  • Parenteral nutrition
  • Randomized clinical trial

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health

Cite this

Poindexter, B. B., Ehrenkranz, R. A., Stoll, B. J., Wright, L. L., Poole, W. K., Oh, W., ... Lemons, J. A. (2004). Parenteral Glutamine Supplementation Does Not Reduce the Risk of Mortality or Late-Onset Sepsis in Extremely Low Birth Weight Infants. Pediatrics, 113(5 I), 1209-1215. https://doi.org/10.1542/peds.113.5.1209

Parenteral Glutamine Supplementation Does Not Reduce the Risk of Mortality or Late-Onset Sepsis in Extremely Low Birth Weight Infants. / Poindexter, Brenda B.; Ehrenkranz, Richard A.; Stoll, Barbara J.; Wright, Linda L.; Poole, W. Kenneth; Oh, William; Bauer, Charles R; Papile, Lu Ann; Tyson, Jon E.; Carlo, Waldemar A.; Laptook, Abbot R.; Narendran, Vivek; Stevenson, David K.; Fanaroff, Avroy A.; Korones, Sheldon B.; Shankaran, Seetha; Finer, Neil N.; Lemons, James A.

In: Pediatrics, Vol. 113, No. 5 I, 01.05.2004, p. 1209-1215.

Research output: Contribution to journalArticle

Poindexter, BB, Ehrenkranz, RA, Stoll, BJ, Wright, LL, Poole, WK, Oh, W, Bauer, CR, Papile, LA, Tyson, JE, Carlo, WA, Laptook, AR, Narendran, V, Stevenson, DK, Fanaroff, AA, Korones, SB, Shankaran, S, Finer, NN & Lemons, JA 2004, 'Parenteral Glutamine Supplementation Does Not Reduce the Risk of Mortality or Late-Onset Sepsis in Extremely Low Birth Weight Infants', Pediatrics, vol. 113, no. 5 I, pp. 1209-1215. https://doi.org/10.1542/peds.113.5.1209
Poindexter, Brenda B. ; Ehrenkranz, Richard A. ; Stoll, Barbara J. ; Wright, Linda L. ; Poole, W. Kenneth ; Oh, William ; Bauer, Charles R ; Papile, Lu Ann ; Tyson, Jon E. ; Carlo, Waldemar A. ; Laptook, Abbot R. ; Narendran, Vivek ; Stevenson, David K. ; Fanaroff, Avroy A. ; Korones, Sheldon B. ; Shankaran, Seetha ; Finer, Neil N. ; Lemons, James A. / Parenteral Glutamine Supplementation Does Not Reduce the Risk of Mortality or Late-Onset Sepsis in Extremely Low Birth Weight Infants. In: Pediatrics. 2004 ; Vol. 113, No. 5 I. pp. 1209-1215.
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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.",
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T1 - Parenteral Glutamine Supplementation Does Not Reduce the Risk of Mortality or Late-Onset Sepsis in Extremely Low Birth Weight Infants

AU - Poindexter, Brenda B.

AU - Ehrenkranz, Richard A.

AU - Stoll, Barbara J.

AU - Wright, Linda L.

AU - Poole, W. Kenneth

AU - Oh, William

AU - Bauer, Charles R

AU - Papile, Lu Ann

AU - Tyson, Jon E.

AU - Carlo, Waldemar A.

AU - Laptook, Abbot R.

AU - Narendran, Vivek

AU - Stevenson, David K.

AU - Fanaroff, Avroy A.

AU - Korones, Sheldon B.

AU - Shankaran, Seetha

AU - Finer, Neil N.

AU - Lemons, James A.

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N2 - 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.

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KW - Randomized clinical trial

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