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NCT01426542 · ClinicalTrials.gov registry record · Phase 1
Preventing Brain Injury in Infants With Congenital Heart Disease
A Phase 1 study, sponsored by University of California, Davis.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
NCT01426542 is a Phase 1 study that has completed, run by University of California, Davis. The registered enrollment target is 24 participants.
The verdict
NCT01426542, a Phase 1 study, has completed, sponsored by University of California, Davis.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
Study Summary
Newborn babies with congenital heart disease often require surgery in the first month of life. The risks of brain damage from congenital heart disease and from the various corrective surgeries are high because of poor levels of oxygen reaching the brain. Topiramate is an anti-convulsant medication that protects brain cells from damage due to low amounts of oxygen in animal studies. The investigators hypothesize that giving topiramate to babies with congenital heart disease before and after surgery will decrease the amount of brain damage caused by the heart disease and/or the surgery to correct the heart disease.
Interventions
- DRUG Topiramate
- OTHER No medication, but routine heart surgery
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2011-03 |
| Est. Completion | 2017-07-28 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01426542
The ClinicalTrials.gov registry entry for NCT01426542 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, Davis, which has 657 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Topiramate is the first listed.
NCT01426542 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01426542 about?
NCT01426542 is a clinical study titled "Preventing Brain Injury in Infants With Congenital Heart Disease". Newborn babies with congenital heart disease often require surgery in the first month of life. The risks of brain damage from congenital heart disease and from the various corrective surgeries are high because of poor levels of oxygen reaching the brain. Topiramate is an anti-convulsant medication t...
What is the current status of trial NCT01426542?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2011-03. Estimated completion is 2017-07-28.
What interventions are being tested in trial NCT01426542?
The interventions under investigation include: Topiramate (DRUG), No medication, but routine heart surgery (OTHER).
Who is sponsoring clinical trial NCT01426542?
This trial is sponsored by University of California, Davis, which has 657 total clinical trials registered on ClinicalTrials.gov.
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