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NCT00009620 · ClinicalTrials.gov registry record · Phase 3
Antenatal Phenobarbital to Prevent Neonatal Intracranial Hemorrhage
A Phase 3 study, sponsored by NICHD Neonatal Research Network.
- Completed
- Registry status
- Phase 3
- Development phase
- 610
- Enrollment target
NCT00009620 is a Phase 3 study that has completed, run by NICHD Neonatal Research Network. The registered enrollment target is 610 participants.
The verdict
NCT00009620, a Phase 3 study, has completed, sponsored by NICHD Neonatal Research Network.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 610 participants
- Enrollment target
Study Summary
This large randomized trial tested whether phenobarbital given to a pregnant woman about to deliver a premature infant would prevent brain injuries in their newborns. Women with 24 to 32 week fetuses who were in preterm labor and were expected to deliver within 24 hrs were randomized to phenobarbital or usual care. They were treated until they deliver or the fetus reaches 33 wks gestation. Babies were followed until discharge and evaluated at 18-22 mos corrected age for neurodevelopmental outcome.
Interventions
- DRUG Saline
- DRUG Phenobarbital
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 610 participants |
| Start Date | 1993-02 |
| Est. Completion | 1997-02 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00009620
The ClinicalTrials.gov registry entry for NCT00009620 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 610 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NICHD Neonatal Research Network, which has 61 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Saline is the first listed.
NCT00009620 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00009620 about?
NCT00009620 is a clinical study titled "Antenatal Phenobarbital to Prevent Neonatal Intracranial Hemorrhage". This large randomized trial tested whether phenobarbital given to a pregnant woman about to deliver a premature infant would prevent brain injuries in their newborns. Women with 24 to 32 week fetuses who were in preterm labor and were expected to deliver within 24 hrs were randomized to phenobarbita...
What is the current status of trial NCT00009620?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 610 participants. The study started on 1993-02. Estimated completion is 1997-02.
What interventions are being tested in trial NCT00009620?
The interventions under investigation include: Saline (DRUG), Phenobarbital (DRUG).
Who is sponsoring clinical trial NCT00009620?
This trial is sponsored by NICHD Neonatal Research Network, which has 61 total clinical trials registered on ClinicalTrials.gov.
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