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Glutamine Supplementation to Prevent Death or Infection in Extremely Premature Infants
NCT00005775 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,433 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NICHD Neonatal Research Network, which has 44 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00005775 reports 15 study locations spanning 12 distinct geographic areas — top geographies include California, Ohio, Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00005775?
The interventions under investigation include: Placebo (DRUG), Glutamine (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00005775?
This trial is sponsored by NICHD Neonatal Research Network, which has 44 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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