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NCT01089504 · ClinicalTrials.gov registry record · Phase 4
Prophylactic Phenobarbital After Neonatal Seizures
A Phase 4 study, sponsored by University of Rochester.
- Terminated
- Registry status
- Phase 4
- Development phase
- 13
- Enrollment target
NCT01089504: Clinical Trial Phase 4 study, sponsored by University of Rochester.
NCT01089504 is a Phase 4 study that was terminated before completion, run by University of Rochester. The registered enrollment target is 13 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01089504, a Phase 4 study, was terminated before completion, sponsored by University of Rochester.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 13 participants
- Enrollment target
Study Summary
The treatment of infants with medications after their seizures have stopped is very variable. No one knows if continuing treatment with phenobarbital for up to several months is helpful or harmful. This clinical trial is designed to help answer that question and provide data that will help determine standard of care for these children.
Primary Outcome
The Bayley Scales of Infant Development (BSID) measure the mental and motor development and test the behavior of infants from one to 42 months of age. The test is intended to measure a child's level of development in three domains: cognitive, motor, and behavioral. The primary outcome is the Bayley assessment of development at 2 years of age. This is a standardized developmental exam that is normalized to the age of the child in months. The mean adjusted score is 100 with a standard deviation of
Interventions
- DRUG placebo
- DRUG phenobarbital
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2010-09 |
| Est. Completion | 2014-11 |
| Phase | Phase 4 |
Why NCT01089504 stopped before completion
NCT01089504 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT01089504 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01089504 about?
NCT01089504 is a clinical study titled "Prophylactic Phenobarbital After Neonatal Seizures". The treatment of infants with medications after their seizures have stopped is very variable. No one knows if continuing treatment with phenobarbital for up to several months is helpful or harmful. This clinical trial is designed to help answer that question and provide data that will help determine...
What is the current status of trial NCT01089504?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 13 participants. The study started on 2010-09. Estimated completion is 2014-11.
What interventions are being tested in trial NCT01089504?
The interventions under investigation include: placebo (DRUG), phenobarbital (DRUG).
Who is sponsoring clinical trial NCT01089504?
This trial is sponsored by University of Rochester, which has 636 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01089504's enrollment target sits among peer trials
13 1910th of 2000 higher than 88 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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