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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 is a Phase 2 study that was terminated before completion, run by Atlantic Health System. The registered enrollment target is 22 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00589953
The ClinicalTrials.gov registry entry for NCT00589953 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 22 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Atlantic Health System, which has 43 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Saline placebo is the first listed.
NCT00589953 reports 0 study locations.
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.
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