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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: Completed Phase 1 study, sponsored by University of California, Davis.
NCT01426542 is a Phase 1 study that has completed, run by University of California, Davis. The registered enrollment target is 24 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Baseline plasma S100B levels will be determined prior to surgery (at enrollment) with repeat levels at the two timepoints after surgery. Main outcome will be change from baseline.
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 |
What the finished NCT01426542 record still lists
NCT01426542 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 2 interventions - of which Topiramate is the first listed.
NCT01426542 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01426542's enrollment target sits among peer trials
24 1520th of 2000 higher than 405 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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