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NCT00005775 · ClinicalTrials.gov registry record · Phase 3
Glutamine Supplementation to Prevent Death or Infection in Extremely Premature Infants
A Phase 3 study of Sepsis and Infant, Newborn, sponsored by NICHD Neonatal Research Network.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,433
- Enrollment target
- 15
- Study locations
NCT00005775 is a Phase 3 study of Sepsis and Infant, Newborn that has completed, run by NICHD Neonatal Research Network. The registered enrollment target is 1,433 participants, below the 6,549-participant average among 90 other Sepsis trials with a reported enrollment target (78% lower). The trial reports 15 study locations across 12 states.
The verdict
NCT00005775, a Phase 3 study of Sepsis and Infant, Newborn, has completed, sponsored by NICHD Neonatal Research Network.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,433 participants
- Enrollment target
- 15
- Study locations
Study 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 Studied
Interventions
- DRUG Placebo
- DRUG Glutamine
Study Locations (15)
California
- Stanford University - Palo Alto
- University of California at San Diego - San Diego
Ohio
- Cincinnati Children's Medical Center - Cincinnati
- Case Western Reserve University, Rainbow Babies and Children's Hospital - Cleveland
Texas
- University of Texas Southwestern Medical Center at Dallas - Dallas
- University of Texas Health Science Center at Houston - Houston
Alabama
- University of Alabama at Birmingham - Birmingham
Connecticut
- Yale University - New Haven
Florida
- University of Miami - Miami
Georgia
- Emory University - Atlanta
Indiana
- Indiana University - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,433 participants |
| Start Date | 1999-07 |
| Est. Completion | 2001-08 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00005775
The ClinicalTrials.gov registry entry for NCT00005775 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,433 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 6,549-participant average among 90 other Sepsis trials with a reported enrollment target (78% lower). The listed sponsor is NICHD Neonatal Research Network, which has 61 total studies on file at ClinicalTrials.gov.
The record links to 5 conditions, with Sepsis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT00005775 reports 15 study locations spanning 12 distinct geographic areas - top geographies include California, Ohio, Texas.
Frequently Asked Questions
What is clinical trial NCT00005775 about?
NCT00005775 is a clinical study titled "Glutamine Supplementation to Prevent Death or Infection in Extremely Premature Infants". 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 ...
What is the current status of trial NCT00005775?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,433 participants. The study started on 1999-07. Estimated completion is 2001-08.
What conditions does trial NCT00005775 study?
This clinical trial studies the following conditions: Sepsis, Infant, Newborn, Infant, Premature, Infant, Small for Gestational Age, Infant, Low Birth Weight.
What interventions are being tested in trial NCT00005775?
The interventions under investigation include: Placebo (DRUG), Glutamine (DRUG).
Who is sponsoring clinical trial NCT00005775?
This trial is sponsored by NICHD Neonatal Research Network, which has 61 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00005775 being conducted?
This trial has 15 study locations across Alabama, California, Connecticut, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.