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NCT03913221 · ClinicalTrials.gov registry record · Phase 1
Caffeine for Hypoxic-Ischemic Encephalopathy
A Phase 1 study, sponsored by University of North Carolina, Chapel Hill.
- Completed
- Registry status
- Phase 1
- Development phase
- 17
- Enrollment target
NCT03913221: Completed Phase 1 study, sponsored by University of North Carolina, Chapel Hill.
NCT03913221 is a Phase 1 study that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 17 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03913221, a Phase 1 study, has completed, sponsored by University of North Carolina, Chapel Hill.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 17 participants
- Enrollment target
Study Summary
Hypoxic-ischemic encephalopathy (HIE) due to perinatal asphyxia is common and often fatal. Therapeutic hypothermia reduces mortality and morbidity in infants with HIE. Even with the widespread use of therapeutic hypothermia, \~60% of infants with HIE die or have neurodevelopmental impairment. As a result, there is an urgent, unmet public health need to develop adjuvant therapies to improve survival and neurodevelopmental outcomes in this population. Caffeine may offer neuroprotection for infants with HIE by blocking adenosine receptors in the brain and reducing neuronal cell death. In animal models of HIE, caffeine reduces white matter brain injury. Drugs in the same class as caffeine (i.e., methylxanthines) have been shown to be protective against acute kidney injury in the setting of HIE. However, their safety and efficacy have not been studied in the setting of therapeutic hypothermia and their effect on neurological outcomes is not known. Since these drugs reduce injury to the kidney in infants with HIE, they may also reduce injury to the brain. This phase I study will evaluate the pharmacokinetics, safety, and preliminary effectiveness of caffeine as an adjuvant therapy to improve neurodevelopmental outcomes in infants with HIE.
Primary Outcome
AUC0-t defines area under the plasma concentration-time curve (AUC) from administration to the last quantifiable concentration at time t.
Interventions
- DRUG Caffeine Citrate 5 mg/kg
- DRUG Caffeine Citrate 10 mg/kg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2019-08-14 |
| Est. Completion | 2024-12-31 |
| Phase | Phase 1 |
What the finished NCT03913221 record still lists
NCT03913221 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (72% lower).
The record links to 0 conditions, and to 2 interventions - of which Caffeine Citrate 5 mg/kg is the first listed.
NCT03913221 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03913221 about?
NCT03913221 is a clinical study titled "Caffeine for Hypoxic-Ischemic Encephalopathy". Hypoxic-ischemic encephalopathy (HIE) due to perinatal asphyxia is common and often fatal. Therapeutic hypothermia reduces mortality and morbidity in infants with HIE. Even with the widespread use of therapeutic hypothermia, \~60% of infants with HIE die or have neurodevelopmental impairment. As a r...
What is the current status of trial NCT03913221?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 17 participants. The study started on 2019-08-14. Estimated completion is 2024-12-31.
What interventions are being tested in trial NCT03913221?
The interventions under investigation include: Caffeine Citrate 5 mg/kg (DRUG), Caffeine Citrate 10 mg/kg (DRUG).
Who is sponsoring clinical trial NCT03913221?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03913221's enrollment target sits among peer trials
17 1785th of 2000 higher than 215 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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