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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, Premature, sponsored by NICHD Neonatal Research Network.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,433
- Enrollment target
- 15
- Study locations
NCT00005775: Completed Phase 3 study of Sepsis and Infant, Premature, sponsored by NICHD Neonatal Research Network.
NCT00005775 is a Phase 3 study of Sepsis and Infant, Premature 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. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00005775, a Phase 3 study of Sepsis and Infant, Premature, 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 |
What the finished NCT00005775 record still lists
NCT00005775 is an interventional study that assigns participants to a tested intervention. Its 1,433 participants enrollment target places it among the larger protocols in the corpus, below the 6,549-participant average among 90 other Sepsis trials with a reported enrollment target (78% lower).
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 lists 15 locations in 12 states (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, Premature, Infant, Newborn, 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.
Learn More About Clinical Trials
Similar trials for Sepsis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00005775's enrollment target sits among peer trials
1,433 17th of 90 higher than 74 of 90 other Sepsis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Sepsis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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