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NCT00513240 · ClinicalTrials.gov registry record · Phase 1
Erythropoetin Neuroprotection for Neonatal Cardiac Surgery
A Phase 1 study, sponsored by Baylor College of Medicine.
- Completed
- Registry status
- Phase 1
- Development phase
- 62
- Enrollment target
NCT00513240: Completed Phase 1 study, sponsored by Baylor College of Medicine.
NCT00513240 is a Phase 1 study that has completed, run by Baylor College of Medicine. The registered enrollment target is 62 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00513240, a Phase 1 study, has completed, sponsored by Baylor College of Medicine.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 62 participants
- Enrollment target
Study Summary
Brain problems occur in neonatal open heart surgery with a frequency of 20-70%, seen on neurological examination, brain imaging such as magnetic resonance imaging (MRI), or long term development problems such as learning disorders and hyperactivity syndromes. This study aims to determine if erythropoetin, a natural hormone made in the body, protects the brain from damage when given in high doses before and during neonatal open heart surgery. We will use brain MRI, brain wave tests (EEG), neurological examination, and long term developmental outcome testing to see if erythropoetin is better than salt water injection (placebo) in protecting the brain.
Primary Outcome
TMS is a measure of developmental maturity of the brain as assessed from T1 and T2-weighted images, grading myelination, cortical infolding, involution of the germinal matrix, and presence of bands of migrating glial cells. The brain MRIs were reviewed for infarction, hemorrhage, white matter injury (WMI), or dural sinovenous thrombosis (DVST). Injuries in each category are scored 0 for none, 1 for mild, 2 for moderate, 3 for severe. The score in each category is then multiplied by a proposed ou
Interventions
- DRUG Normal saline
- DRUG Erythropoetin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 62 participants |
| Start Date | 2006-09 |
| Est. Completion | 2015-09 |
| Phase | Phase 1 |
What the finished NCT00513240 record still lists
NCT00513240 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 62 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Normal saline is the first listed.
NCT00513240 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00513240 about?
NCT00513240 is a clinical study titled "Erythropoetin Neuroprotection for Neonatal Cardiac Surgery". Brain problems occur in neonatal open heart surgery with a frequency of 20-70%, seen on neurological examination, brain imaging such as magnetic resonance imaging (MRI), or long term development problems such as learning disorders and hyperactivity syndromes. This study aims to determine if erythrop...
What is the current status of trial NCT00513240?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 62 participants. The study started on 2006-09. Estimated completion is 2015-09.
What interventions are being tested in trial NCT00513240?
The interventions under investigation include: Normal saline (DRUG), Erythropoetin (DRUG).
Who is sponsoring clinical trial NCT00513240?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00513240's enrollment target sits among peer trials
62 824th of 2000 higher than 1,173 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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