Glutamine Supplementation to Prevent Death or Infection in Extremely Premature Infants

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.

Conditions

• Infant, Newborn
• Infant, Low Birth Weight
• Infant, Small for Gestational Age
• Infant, Premature
• Sepsis

Interventions

DRUG

Glutamine

Infants randomized to glutamine supplementation will receive glutamine any time that parenteral nutrition is required during the first 120 days of hospitalization.

DRUG

Placebo

TrophAmine given any time that parenteral nutrition is required during the first 120 days of hospitalization.

Sponsors & Collaborators

• National Center for Research Resources (NCRR)

  collaborator NIH

• NICHD Neonatal Research Network

  lead NETWORK

Principal Investigators

• Brenda B. Poindexter, MD MS · Indiana University

• Waldemar A. Carlo, MD · University of Alabama at Birmingham

• Neil N. Finer, MD · University of California, San Diego

• Avroy A. Fanaroff, MD · Case Western Reserve University

• Edward F. Donovan, MD · Children's Hospital Medical Center, Cincinnati

• Barbara J. Stoll, MD · Emory University

• Charles R. Bauer, MD · University of Miami

• Lu-Ann Papile, MD · University of New Mexico

• W. Kenneth Poole, PhD · RTI International

• David K. Stevenson, MD · Stanford University

• Sheldon B. Korones, MD · University of Tennessee

• Jon E. Tyson, MD MPH · The University of Texas Health Science Center, Houston

• Abbot R. Laptook, MD · University of Texas Southwestern Medical Center

• Seetha Shankaran, MD · Wayne State University

• William Oh, MD · Women and Infants Hospital, Brown University

• Richard A. Ehrenkranz, MD · Yale University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

SINGLE_GROUP

Eligibility

Max Age

72 Hours

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

1999-07-31

Primary Completion

2000-12-31

Completion

2001-08-31

Countries

• United States

Study Locations