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NCT06448780 · ClinicalTrials.gov registry record · Phase 1
Dose Optimization of Caffeine for HIE
A Phase 1 study of Hypoxic Ischemic Encephalopathy, sponsored by University of North Carolina, Chapel Hill.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
- 2
- Study locations
NCT06448780: Recruiting Phase 1 study of Hypoxic Ischemic Encephalopathy, sponsored by University of North Carolina, Chapel Hill.
NCT06448780 is a Phase 1 study of Hypoxic Ischemic Encephalopathy that is actively recruiting participants, run by University of North Carolina, Chapel Hill. The registered enrollment target is 16 participants, below the 82-participant average among 13 other Hypoxic Ischemic Encephalopathy trials with a reported enrollment target (80% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06448780, a Phase 1 study of Hypoxic Ischemic Encephalopathy, is actively recruiting participants, sponsored by University of North Carolina, Chapel Hill.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
- 2
- Study locations
Study Summary
This is a phase Ib, open-label, dose-validating and safety study of caffeine in neonates with hypoxic-ischemic encephalopathy (HIE) undergoing therapeutic hypothermia.
Primary Outcome
Clearance is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Caffeine concentrations will be used to calculate population estimates of caffeine clearance, with inter-individual variabilty and residual variabilty .
Conditions Studied
Interventions
- DRUG Caffeine citrate 20 mg/kg
- DRUG Caffeine citrate 30 mg/kg
Study Locations (2)
North Carolina
- The University of North Carolina at Chapel Hill Newborn Critical Care Center - Chapel Hill
- Novant Health New Hanover Regional Medical Center - Wilmington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2024-07-26 |
| Est. Completion | 2028-11 |
| Phase | Phase 1 |
What NCT06448780 shows while recruiting
NCT06448780 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 82-participant average among 13 other Hypoxic Ischemic Encephalopathy trials with a reported enrollment target (80% lower).
The record links to 1 condition, with Hypoxic Ischemic Encephalopathy appearing as the primary indexed condition, and to 2 interventions - of which Caffeine citrate 20 mg/kg is the first listed.
NCT06448780 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT06448780 about?
NCT06448780 is a clinical study titled "Dose Optimization of Caffeine for HIE". This is a phase Ib, open-label, dose-validating and safety study of caffeine in neonates with hypoxic-ischemic encephalopathy (HIE) undergoing therapeutic hypothermia.
What is the current status of trial NCT06448780?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2024-07-26. Estimated completion is 2028-11.
What conditions does trial NCT06448780 study?
This clinical trial studies the following conditions: Hypoxic Ischemic Encephalopathy.
What interventions are being tested in trial NCT06448780?
The interventions under investigation include: Caffeine citrate 20 mg/kg (DRUG), Caffeine citrate 30 mg/kg (DRUG).
Who is sponsoring clinical trial NCT06448780?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06448780 being conducted?
This trial has 2 study locations across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06448780's enrollment target sits among peer trials
16 12th of 13 higher than 2 of 13 other Hypoxic Ischemic Encephalopathy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hypoxic Ischemic Encephalopathy 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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