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Glutamine Supplementation to Prevent Death or Infection in Extremely Premature Infants (Glutamine)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00005775
First Posted: June 2, 2000
Last Update Posted: June 8, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Center for Research Resources (NCRR)
Information provided by:
NICHD Neonatal Research Network
June 1, 2000
June 2, 2000
June 8, 2015
July 1999
December 2000   (Final data collection date for primary outcome measure)
Death or late-onset sepsis [ Time Frame: At hospital discharge ]
Not Provided
Complete list of historical versions of study NCT00005775 on ClinicalTrials.gov Archive Site
  • Tolerance of enteral feeding (number of days to reach full enteral feeds) and decrease number of episodes of feeding intolerance [ Time Frame: At hospital discharge ]
  • Necrotizing Enterocolitis [ Time Frame: At hospital discharge ]
  • Episodes of late-onset sepsis [ Time Frame: At hospital discharge ]
  • Growth (days to reach 1500 grams) [ Time Frame: At hospital discharge ]
  • Number of days on parenteral nutrition [ Time Frame: At hospital discharge ]
  • Length of stay in NICU [ Time Frame: At hospital discharge ]
  • Neurodevelopmental outcome [ Time Frame: 18-22 months corrrected age ]
  • Levels of pro-inflammatory cytokines [ Time Frame: In the perinatal period ]
Not Provided
Not Provided
Not Provided
 
Glutamine Supplementation to Prevent Death or Infection in Extremely Premature Infants
Randomized Controlled Trial of Parenteral Glutamine Supplementation for Extremely-Low-Birth-Weight (ELBW) Infants
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.

Meeting the protein and energy requirements of extremely premature infants in early postnatal life requires early hyperalimentation and the gradual introduction of enteral feedings. Glutamine, which is the most abundant amino acid in the human body and taken up in greatest quantity by the fetus from the placenta, is not routinely provided in neonatal parenteral nutrition preparations.

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.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Infant, Newborn
  • Infant, Low Birth Weight
  • Infant, Small for Gestational Age
  • Infant, Premature
  • Sepsis
  • Drug: Glutamine
    Infants randomized to glutamine supplementation will receive glutamine any time that parenteral nutrition is required during the first 120 days of hospitalization.
    Other Names:
    • L-Glutamine
    • TrophAmine
  • Drug: Placebo
    TrophAmine given any time that parenteral nutrition is required during the first 120 days of hospitalization.
    Other Name: TrophAmine
  • Experimental: Glutamine
    TrophAmine (B. Braun/McGaw) with cysteine hydrochloride (40mg/gm amino acids) with L-glutamine added (20% of the total amount of amino acids)
    Intervention: Drug: Glutamine
  • Placebo Comparator: Placebo
    Standard TrophAmine (B. Braun/McGaw) with cysteine hydrochloride (40mg/gm amino acids)
    Intervention: Drug: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1433
August 2001
December 2000   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 401-1000 gm
  • More than 12 hrs and less than 72 hrs after birth; intravenous access
  • Parental consent

Exclusion Criteria:

  • One or more major congenital anomalies
  • Infants meeting criteria for terminal illness
  • Congenital nonbacterial infection with overt signs at birth
Sexes Eligible for Study: All
up to 72 Hours   (Child)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00005775
NICHD-NRN-0020
U10HD027856 ( U.S. NIH Grant/Contract )
U10HD021364 ( U.S. NIH Grant/Contract )
U10HD034216 ( U.S. NIH Grant/Contract )
U10HD034167 ( U.S. NIH Grant/Contract )
U10HD021397 ( U.S. NIH Grant/Contract )
U10HD027853 ( U.S. NIH Grant/Contract )
U10HD027871 ( U.S. NIH Grant/Contract )
U10HD021415 ( U.S. NIH Grant/Contract )
U10HD027904 ( U.S. NIH Grant/Contract )
U10HD027881 ( U.S. NIH Grant/Contract )
U10HD021385 ( U.S. NIH Grant/Contract )
U10HD027851 ( U.S. NIH Grant/Contract )
U10HD027880 ( U.S. NIH Grant/Contract )
U10HD021373 ( U.S. NIH Grant/Contract )
U01HD036790 ( U.S. NIH Grant/Contract )
M01RR008084 ( U.S. NIH Grant/Contract )
M01RR006022 ( U.S. NIH Grant/Contract )
M01RR000750 ( U.S. NIH Grant/Contract )
M01RR000997 ( U.S. NIH Grant/Contract )
M01RR000070 ( U.S. NIH Grant/Contract )
M01RR001032 ( U.S. NIH Grant/Contract )
Yes
Not Provided
Not Provided
Brenda B. Poindexter, Lead Principal Investigator, Indiana University
NICHD Neonatal Research Network
National Center for Research Resources (NCRR)
Principal Investigator: Brenda B. Poindexter, MD MS Indiana University
Principal Investigator: Waldemar A. Carlo, MD University of Alabama at Birmingham
Principal Investigator: Neil N. Finer, MD University of California, San Diego
Principal Investigator: Avroy A. Fanaroff, MD Case Western Reserve University
Principal Investigator: Edward F. Donovan, MD Children's Hospital Medical Center, Cincinnati
Principal Investigator: Barbara J. Stoll, MD Emory University
Principal Investigator: Charles R. Bauer, MD University of Miami
Principal Investigator: Lu-Ann Papile, MD University of New Mexico
Principal Investigator: W. Kenneth Poole, PhD RTI International
Principal Investigator: David K. Stevenson, MD Stanford University
Principal Investigator: Sheldon B. Korones, MD University of Tennessee
Principal Investigator: Jon E. Tyson, MD MPH The University of Texas Health Science Center, Houston
Principal Investigator: Abbot R. Laptook, MD University of Texas Southwestern Medical Center
Principal Investigator: Seetha Shankaran, MD Wayne State University
Principal Investigator: William Oh, MD Women and Infants Hospital, Brown University
Principal Investigator: Richard A. Ehrenkranz, MD Yale University
NICHD Neonatal Research Network
June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP