Glutamine Supplementation to Prevent Death or Infection in Extremely Premature Infants

PHASE3CompletedINTERVENTIONAL
Enrollment

1,433

Participants

Timeline

Start Date

July 31, 1999

Primary Completion Date

December 31, 2000

Study Completion Date

August 31, 2001

Conditions
Infant, NewbornInfant, Low Birth WeightInfant, Small for Gestational AgeInfant, PrematureSepsis
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.

Trial Locations (15)

27705

RTI International, Durham

30303

Emory University, Atlanta

33136

University of Miami, Miami

35233

University of Alabama at Birmingham, Birmingham

44106

Case Western Reserve University, Rainbow Babies and Children's Hospital, Cleveland

45267

Cincinnati Children's Medical Center, Cincinnati

46202

Indiana University, Indianapolis

48201

Wayne State University, Detroit

75235

University of Texas Southwestern Medical Center at Dallas, Dallas

77030

University of Texas Health Science Center at Houston, Houston

87131

University of New Mexico, Albuquerque

94304

Stanford University, Palo Alto

92103-8774

University of California at San Diego, San Diego

06504

Yale University, New Haven

02905

Brown University, Women & Infants Hospital of Rhode Island, Providence

All Listed Sponsors
collaborator

National Center for Research Resources (NCRR)

NIH

lead

NICHD Neonatal Research Network

NETWORK

NCT00005775 - Glutamine Supplementation to Prevent Death or Infection in Extremely Premature Infants | Biotech Hunter | Biotech Hunter