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NCT00576381 · ClinicalTrials.gov registry record · Phase 1
Understanding Dexmedetomidine in Neonates After Open Heart Surgery
A Phase 1 study of Tetrology of Fallot and Heart Ventricle, sponsored by Athena Zuppa.
- Completed
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT00576381: Completed Phase 1 study of Tetrology of Fallot and Heart Ventricle, sponsored by Athena Zuppa.
NCT00576381 is a Phase 1 study of Tetrology of Fallot and Heart Ventricle that has completed, run by Athena Zuppa. The registered enrollment target is 30 participants, below the 82-participant average among 3 other Tetrology of Fallot trials with a reported enrollment target (63% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00576381, a Phase 1 study of Tetrology of Fallot and Heart Ventricle, has completed, sponsored by Athena Zuppa.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to determine what happens to dexmedetomidine in the body after it has been given to a newborn after heart surgery. We want to learn how long the drug stays in the body, how the drug is metabolized by the body, and how well the medicine works at a particular dose or amount.
Primary Outcome
This study measured the concentration of dex in the body and used those concentrations to determine how quickly the body metabolizes and eliminates dex(concentration-time or pharmacokinetic profile).The concentration of dex in the body is determined through serial blood sampling while administering dex and following discontinuation.
Conditions Studied
Interventions
- DRUG Dexmedetomidine
Study Locations (1)
Pennsylvania
- The Children's Hospital of Philadelphia - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2006-04 |
| Est. Completion | 2010-12 |
| Phase | Phase 1 |
What the finished NCT00576381 record still lists
NCT00576381 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 82-participant average among 3 other Tetrology of Fallot trials with a reported enrollment target (63% lower).
The record links to 3 conditions, with Tetrology of Fallot appearing as the primary indexed condition, and to 1 intervention - of which Dexmedetomidine is the first listed.
NCT00576381 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT00576381 about?
NCT00576381 is a clinical study titled "Understanding Dexmedetomidine in Neonates After Open Heart Surgery". The purpose of this study is to determine what happens to dexmedetomidine in the body after it has been given to a newborn after heart surgery. We want to learn how long the drug stays in the body, how the drug is metabolized by the body, and how well the medicine works at a particular dose or amoun...
What is the current status of trial NCT00576381?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2006-04. Estimated completion is 2010-12.
What conditions does trial NCT00576381 study?
This clinical trial studies the following conditions: Tetrology of Fallot, Heart Ventricle, Hypoplastic Left Heart.
What interventions are being tested in trial NCT00576381?
The interventions under investigation include: Dexmedetomidine (DRUG).
Who is sponsoring clinical trial NCT00576381?
This trial is sponsored by Athena Zuppa, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00576381 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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