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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 is a Phase 1 study that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 17 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03913221
The ClinicalTrials.gov registry entry for NCT03913221 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 17 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of North Carolina, Chapel Hill, which has 1,109 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Caffeine Citrate 5 mg/kg is the first listed.
NCT03913221 reports 0 study locations.
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.
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