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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 intolerance

Necrotizing 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

Page last updated: August 23, 2015

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