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NCT03417999 · ClinicalTrials.gov registry record · Phase 1
Pharmacokinetic Study of Intranasal Dexmedetomidine in Pediatric Patients With Congenital Heart Disease
A Phase 1 study, sponsored by Children's Hospital of Philadelphia.
- Terminated
- Registry status
- Phase 1
- Development phase
- 28
- Enrollment target
NCT03417999: Clinical Trial Phase 1 study, sponsored by Children's Hospital of Philadelphia.
NCT03417999 is a Phase 1 study that was terminated before completion, run by Children's Hospital of Philadelphia. The registered enrollment target is 28 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (53% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03417999, a Phase 1 study, was terminated before completion, sponsored by Children's Hospital of Philadelphia.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 28 participants
- Enrollment target
Study Summary
The main objectives of the study are to determine peak plasma drug concentration levels and corresponding time of dexmedetomidine following intranasal administration in children age ≥1 mo to ≤ 6 yr with congenital heart disease undergoing an elective diagnostic or interventional cardiac catheterization procedure.
Primary Outcome
Following the administration of atomized intranasal dexmedetomidine, serum samples will be drawn at 0, 10, 15, 20, 30, 45, 60, 90, 120, 180, 240 and 300 minutes post drug administration. This is the number of samples obtained per subject.
Interventions
- DRUG Dexmedetomidine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2018-06-14 |
| Est. Completion | 2021-10-12 |
| Phase | Phase 1 |
Why NCT03417999 stopped before completion
NCT03417999 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (53% lower).
The record links to 0 conditions, and to 1 intervention - of which Dexmedetomidine is the first listed.
NCT03417999 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03417999 about?
NCT03417999 is a clinical study titled "Pharmacokinetic Study of Intranasal Dexmedetomidine in Pediatric Patients With Congenital Heart Disease". The main objectives of the study are to determine peak plasma drug concentration levels and corresponding time of dexmedetomidine following intranasal administration in children age ≥1 mo to ≤ 6 yr with congenital heart disease undergoing an elective diagnostic or interventional cardiac catheterizat...
What is the current status of trial NCT03417999?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 28 participants. The study started on 2018-06-14. Estimated completion is 2021-10-12.
What interventions are being tested in trial NCT03417999?
The interventions under investigation include: Dexmedetomidine (DRUG).
Who is sponsoring clinical trial NCT03417999?
This trial is sponsored by Children's Hospital of Philadelphia, which has 431 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03417999's enrollment target sits among peer trials
28 1447th of 2000 higher than 538 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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