Glutamine Supplementation to Prevent Death or Infection in Extremely Premature Infants
NCT ID: NCT00005775
Last Updated: 2015-06-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
1433 participants
INTERVENTIONAL
1999-07-31
2001-08-31
Brief Summary
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Detailed Description
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This large multicenter double-masked clinical trial tested whether supplementation of standard neonatal parenteral nutrition with glutamine would reduce the risk of death or late-onset sepsis in extremely-low-birth-weight (ELBW, less than or equal to 1000 gm) infants. Neonates with birth weights of 401-1000gm were randomized to standard TrophAmine or TrophAmine supplemented with glutamine before 72 hours and continued until the infants are tolerating full enteral feedings.
Infants received a neurodevelopmental assessment by masked, certified examiners at 18-22 months postmenstrual age.
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
QUADRUPLE
Study Groups
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Glutamine
TrophAmine (B. Braun/McGaw) with cysteine hydrochloride (40mg/gm amino acids) with L-glutamine added (20% of the total amount of amino acids)
Glutamine
Infants randomized to glutamine supplementation will receive glutamine any time that parenteral nutrition is required during the first 120 days of hospitalization.
Placebo
Standard TrophAmine (B. Braun/McGaw) with cysteine hydrochloride (40mg/gm amino acids)
Placebo
TrophAmine given any time that parenteral nutrition is required during the first 120 days of hospitalization.
Interventions
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Glutamine
Infants randomized to glutamine supplementation will receive glutamine any time that parenteral nutrition is required during the first 120 days of hospitalization.
Placebo
TrophAmine given any time that parenteral nutrition is required during the first 120 days of hospitalization.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* More than 12 hrs and less than 72 hrs after birth; intravenous access
* Parental consent
Exclusion Criteria
* Infants meeting criteria for terminal illness
* Congenital nonbacterial infection with overt signs at birth
72 Hours
ALL
No
Sponsors
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National Center for Research Resources (NCRR)
NIH
NICHD Neonatal Research Network
NETWORK
Responsible Party
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Indiana University
Principal Investigators
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Brenda B. Poindexter, MD MS
Role: PRINCIPAL_INVESTIGATOR
Indiana University
Waldemar A. Carlo, MD
Role: PRINCIPAL_INVESTIGATOR
University of Alabama at Birmingham
Neil N. Finer, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Diego
Avroy A. Fanaroff, MD
Role: PRINCIPAL_INVESTIGATOR
Case Western Reserve University
Edward F. Donovan, MD
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital Medical Center, Cincinnati
Barbara J. Stoll, MD
Role: PRINCIPAL_INVESTIGATOR
Emory University
Charles R. Bauer, MD
Role: PRINCIPAL_INVESTIGATOR
University of Miami
Lu-Ann Papile, MD
Role: PRINCIPAL_INVESTIGATOR
University of New Mexico
W. Kenneth Poole, PhD
Role: PRINCIPAL_INVESTIGATOR
RTI International
David K. Stevenson, MD
Role: PRINCIPAL_INVESTIGATOR
Stanford University
Sheldon B. Korones, MD
Role: PRINCIPAL_INVESTIGATOR
University of Tennessee
Jon E. Tyson, MD MPH
Role: PRINCIPAL_INVESTIGATOR
The University of Texas Health Science Center, Houston
Abbot R. Laptook, MD
Role: PRINCIPAL_INVESTIGATOR
University of Texas Southwestern Medical Center
Seetha Shankaran, MD
Role: PRINCIPAL_INVESTIGATOR
Wayne State University
William Oh, MD
Role: PRINCIPAL_INVESTIGATOR
Women and Infants Hospital, Brown University
Richard A. Ehrenkranz, MD
Role: PRINCIPAL_INVESTIGATOR
Yale University
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Stanford University
Palo Alto, California, United States
University of California at San Diego
San Diego, California, United States
Yale University
New Haven, Connecticut, United States
University of Miami
Miami, Florida, United States
Emory University
Atlanta, Georgia, United States
Indiana University
Indianapolis, Indiana, United States
Wayne State University
Detroit, Michigan, United States
University of New Mexico
Albuquerque, New Mexico, United States
RTI International
Durham, North Carolina, United States
Cincinnati Children's Medical Center
Cincinnati, Ohio, United States
Case Western Reserve University, Rainbow Babies and Children's Hospital
Cleveland, Ohio, United States
Brown University, Women & Infants Hospital of Rhode Island
Providence, Rhode Island, United States
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, United States
University of Texas Health Science Center at Houston
Houston, Texas, United States
Countries
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References
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Poindexter BB, Ehrenkranz RA, Stoll BJ, Koch MA, Wright LL, Oh W, Papile LA, Bauer CR, Carlo WA, Donovan EF, Fanaroff AA, Korones SB, Laptook AR, Shankaran S, Stevenson DK, Tyson JE, Lemons JA; National Institute of Child Health and Human Development Neonatal Research Network. Effect of parenteral glutamine supplementation on plasma amino acid concentrations in extremely low-birth-weight infants. Am J Clin Nutr. 2003 Mar;77(3):737-43. doi: 10.1093/ajcn/77.3.737.
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; National Institute of Child Health and Human Development Neonatal Research Network. Parenteral glutamine supplementation does not reduce the risk of mortality or late-onset sepsis in extremely low birth weight infants. Pediatrics. 2004 May;113(5):1209-15. doi: 10.1542/peds.113.5.1209.
Oh W, Poindexter BB, Perritt R, Lemons JA, Bauer CR, Ehrenkranz RA, Stoll BJ, Poole K, Wright LL; Neonatal Research Network. Association between fluid intake and weight loss during the first ten days of life and risk of bronchopulmonary dysplasia in extremely low birth weight infants. J Pediatr. 2005 Dec;147(6):786-90. doi: 10.1016/j.jpeds.2005.06.039.
Poindexter BB, Langer JC, Dusick AM, Ehrenkranz RA; National Institute of Child Health and Human Development Neonatal Research Network. Early provision of parenteral amino acids in extremely low birth weight infants: relation to growth and neurodevelopmental outcome. J Pediatr. 2006 Mar;148(3):300-305. doi: 10.1016/j.jpeds.2005.10.038.
Vohr BR, Poindexter BB, Dusick AM, McKinley LT, Wright LL, Langer JC, Poole WK; NICHD Neonatal Research Network. Beneficial effects of breast milk in the neonatal intensive care unit on the developmental outcome of extremely low birth weight infants at 18 months of age. Pediatrics. 2006 Jul;118(1):e115-23. doi: 10.1542/peds.2005-2382.
Vohr BR, Poindexter BB, Dusick AM, McKinley LT, Higgins RD, Langer JC, Poole WK; National Institute of Child Health and Human Development National Research Network. Persistent beneficial effects of breast milk ingested in the neonatal intensive care unit on outcomes of extremely low birth weight infants at 30 months of age. Pediatrics. 2007 Oct;120(4):e953-9. doi: 10.1542/peds.2006-3227.
Meinzen-Derr J, Poindexter B, Wrage L, Morrow AL, Stoll B, Donovan EF. Role of human milk in extremely low birth weight infants' risk of necrotizing enterocolitis or death. J Perinatol. 2009 Jan;29(1):57-62. doi: 10.1038/jp.2008.117. Epub 2008 Aug 21.
Peralta-Carcelen M, Moses M, Adams-Chapman I, Gantz M, Vohr BR; NICHD Neonatal Research Network; National Institutes of Health. Stability of neuromotor outcomes at 18 and 30 months of age after extremely low birth weight status. Pediatrics. 2009 May;123(5):e887-95. doi: 10.1542/peds.2008-0135.
Amari S, Shahrook S, Namba F, Ota E, Mori R. Branched-chain amino acid supplementation for improving growth and development in term and preterm neonates. Cochrane Database Syst Rev. 2020 Oct 2;10(10):CD012273. doi: 10.1002/14651858.CD012273.pub2.
Related Links
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NICHD Neonatal Research Network
Click here for the Cochrane review "Glutamine supplementation for preventionof morbidity in the preterm infant."
NICHD Pregnancy \& Perinatology Branch
Other Identifiers
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NICHD-NRN-0020
Identifier Type: -
Identifier Source: org_study_id
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