Glutamine Supplementation to Prevent Death or Infection in Extremely Premature Infants
Information source: NICHD Neonatal Research Network
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Infant, Newborn; Infant, Low Birth Weight; Infant, Small for Gestational Age; Infant, Premature; Sepsis
Intervention: Glutamine (Drug); Placebo (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: NICHD Neonatal Research Network Official(s) and/or principal investigator(s): Brenda B. Poindexter, MD MS, Principal Investigator, Affiliation: Indiana University Waldemar A. Carlo, MD, Principal Investigator, Affiliation: University of Alabama at Birmingham Neil N. Finer, MD, Principal Investigator, Affiliation: University of California, San Diego Avroy A. Fanaroff, MD, Principal Investigator, Affiliation: Case Western Reserve University Edward F. Donovan, MD, Principal Investigator, Affiliation: Cincinnati Children's Medical Center Barbara J. Stoll, MD, Principal Investigator, Affiliation: Emory University Charles R. Bauer, MD, Principal Investigator, Affiliation: University of Miami Lu-Ann Papile, MD, Principal Investigator, Affiliation: University of New Mexico W. Kenneth Poole, PhD, Principal Investigator, Affiliation: RTI International David K. Stevenson, MD, Principal Investigator, Affiliation: Stanford University Sheldon B. Korones, MD, Principal Investigator, Affiliation: University of Tennessee Jon E. Tyson, MD MPH, Principal Investigator, Affiliation: The University of Texas Health Science Center, Houston Abbot R. Laptook, MD, Principal Investigator, Affiliation: University of Texas Southwestern Medical Center Seetha Shankaran, MD, Principal Investigator, Affiliation: Wayne State University William Oh, MD, Principal Investigator, Affiliation: Women and Infants Hospital, Brown University Richard A. Ehrenkranz, MD, Principal Investigator, Affiliation: Yale University
Summary
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.
Clinical Details
Official title: Randomized Controlled Trial of Parenteral Glutamine Supplementation for Extremely-Low-Birth-Weight (ELBW) Infants
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Death or late-onset sepsis
Secondary outcome: Tolerance of enteral feeding (number of days to reach full enteral feeds) and decrease number of episodes of feeding intoleranceNecrotizing Enterocolitis Episodes of late-onset sepsis Growth (days to reach 1500 grams) Number of days on parenteral nutrition Length of stay in NICU Neurodevelopmental outcome Levels of pro-inflammatory cytokines
Detailed description:
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.
Eligibility
Minimum age: N/A.
Maximum age: 72 Hours.
Gender(s): Both.
Criteria:
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
Locations and Contacts
University of Alabama at Birmingham, Birmingham, Alabama 35233, United States
Stanford University, Palo Alto, California 94304, United States
University of California at San Diego, San Diego, California 92103-8774, United States
Yale University, New Haven, Connecticut 06504, United States
University of Miami, Miami, Florida 33136, United States
Emory University, Atlanta, Georgia 30303, United States
Indiana University, Indianapolis, Indiana 46202, United States
Wayne State University, Detroit, Michigan 48201, United States
University of New Mexico, Albuquerque, New Mexico 87131, United States
RTI International, Durham, North Carolina 27705, United States
Cincinnati Children's Medical Center, Cincinnati, Ohio 45267, United States
Case Western Reserve University, Rainbow Babies and Children's Hospital, Cleveland, Ohio 44106, United States
Brown University, Women & Infants Hospital of Rhode Island, Providence, Rhode Island 02905, United States
University of Texas Southwestern Medical Center at Dallas, Dallas, Texas 75235, United States
University of Texas Health Science Center at Houston, Houston, Texas 77030, United States
Additional Information
NICHD Neonatal Research Network Click here for the Cochrane review "Glutamine supplementation for preventionof morbidity in the preterm infant." NICHD Pregnancy & Perinatology Branch
Starting date: July 1999
Last updated: June 3, 2015
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