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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 is a Phase 1 study that has completed, run by Baylor College of Medicine. The registered enrollment target is 62 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00513240
The ClinicalTrials.gov registry entry for NCT00513240 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 62 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Baylor College of Medicine, which has 616 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Normal saline is the first listed.
NCT00513240 reports 0 study locations.
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.
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