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NCT00589953 · ClinicalTrials.gov registry record · Phase 2
High-Dose Erythropoietin in Extremely Premature Infants to Prevent/Attenuate Brain Injury: A Phase II Study
A Phase 2 study, sponsored by Atlantic Health System.
- Terminated
- Registry status
- Phase 2
- Development phase
- 22
- Enrollment target
NCT00589953: Clinical Trial Phase 2 study, sponsored by Atlantic Health System.
NCT00589953 is a Phase 2 study that was terminated before completion, run by Atlantic Health System. The registered enrollment target is 22 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00589953, a Phase 2 study, was terminated before completion, sponsored by Atlantic Health System.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 22 participants
- Enrollment target
Study Summary
The highest risk for perinatal brain injury occurs among extremely premature infants who weigh less than 1250 grams at birth. Such perinatal brain injury is currently irreversible, associated with neurodevelopmental disability, and without adequate treatment modalities. Research in recent years suggest in both animal and human studies that erythropoietin (Epo) may have significant neuroprotective effects. Given the historical safe medical profile of Epo when used for anemia of prematurity but the likely need for a greater dosage regimen for activation of neuroprotective pathways against neonatal brain injury, we therefore propose this phase II study of high-dose Epo in very low birth weight infants for the prevention and/or attenuation of prematurity-related cerebral hemorrhagic-ischemic injury.
Interventions
- DRUG Saline placebo
- DRUG Erythropoietin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2007-07 |
| Est. Completion | 2010-09 |
| Phase | Phase 2 |
Why NCT00589953 stopped before completion
NCT00589953 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 2 interventions - of which Saline placebo is the first listed.
NCT00589953 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00589953 about?
NCT00589953 is a clinical study titled "High-Dose Erythropoietin in Extremely Premature Infants to Prevent/Attenuate Brain Injury: A Phase II Study". The highest risk for perinatal brain injury occurs among extremely premature infants who weigh less than 1250 grams at birth. Such perinatal brain injury is currently irreversible, associated with neurodevelopmental disability, and without adequate treatment modalities. Research in recent years sugg...
What is the current status of trial NCT00589953?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 22 participants. The study started on 2007-07. Estimated completion is 2010-09.
What interventions are being tested in trial NCT00589953?
The interventions under investigation include: Saline placebo (DRUG), Erythropoietin (DRUG).
Who is sponsoring clinical trial NCT00589953?
This trial is sponsored by Atlantic Health System, which has 43 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00589953's enrollment target sits among peer trials
22 1790th of 2000 higher than 207 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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