Glutamine Supplementation to Prevent Death or Infection in Extremely Premature Infants

Completed · Phase 3 · Has a placebo group

Conditions studied: Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature, Sepsis

In brief

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.

Key facts

Study ID

NCT00005775

Run by

NICHD Neonatal Research Network

People needed

1433

Starts

1999-07-01

Expected to finish

2001-08-01

Last updated by the study team

2015-06-08

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• One or more major congenital anomalies
• Infants meeting criteria for terminal illness
• Congenital nonbacterial infection with overt signs at birth

Where it is running

• 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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.