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PEDIATRICS Vol. 113 No. 5 May 2004, pp. 1209-1215

ARTICLES

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

Brenda B. Poindexter, MD^*, Richard A. Ehrenkranz, MD, Barbara J. Stoll, MD, Linda L. Wright, MD^||, W. Kenneth Poole, PhD^¶, William Oh, MD^#, Charles R. Bauer, MD^**, Lu-Ann Papile, MD, Jon E. Tyson, MD, MPH, Waldemar A. Carlo, MD^||||, Abbot R. Laptook, MD^¶¶, Vivek Narendran, MD, MRCP^##, David K. Stevenson, MD^***, Avroy A. Fanaroff, MB, BCh, Sheldon B. Korones, MD, Seetha Shankaran, MD^||||||, Neil N. Finer, MD^¶¶¶, James A. Lemons, MD^* and for the National Institute of Child Health and Human Development Neonatal Research Network

^* Department of Pediatrics, Indiana University School of Medicine, Indianapolis, Indiana
Department of Pediatrics, Yale University School of Medicine, New Haven, Connecticut
Department of Pediatrics, Emory University School of Medicine, Atlanta, Georgia
^|| National Institute of Child Health and Human Development, Bethesda, Maryland
^¶ Research Triangle Institute, Research Triangle Park, North Carolina
^# Department of Pediatrics, Brown University, Providence, Rhode Island
^** Department of Pediatrics, University of Miami, Miami, Florida
Department of Pediatrics, University of New Mexico School of Medicine, Albuquerque, New Mexico
Center for Clinical Research and Evidence Based Medicine, University of Texas Health Science Center at Houston Medical School, Houston, Texas
^|||| Department of Pediatrics, University of Alabama, Birmingham, Alabama
^¶¶ Department of Pediatrics, University of Texas Southwestern Medical Center, Dallas, Texas
^## Department of Pediatrics, College of Medicine, University of Cincinnati, Cincinnati, Ohio
^*** Division of Neonatology, Stanford University Medical Center, Palo Alto, California
Department of Pediatrics, Case Western Reserve University, Cleveland, Ohio
The Newborn Center, University of Tennessee, Memphis, Tennessee
^|||||| Division of Neonatology and Perinatal Medicine, Wayne State University, Detroit, Michigan
^¶¶¶ University of California at San Diego Medical Center, University of California, San Diego, California

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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Key Words: glutamine • parenteral nutrition • extremely low birth weight infants • randomized clinical trial

Abbreviations: PN, parenteral nutrition • ELBW, extremely low birth weight • RR, relative risk • CI, confidence interval

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Received for publication May 15, 2003; Accepted Jul 23, 2003.

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