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Dose Optimization of Caffeine in Neonates With Hypoxic-Ischemic Encephalopathy
This is a phase Ib, open-label, dose-validating and safety study of caffeine in neonates with hypoxic-ischemic encephalopathy (HIE) undergoing therapeutic hypothermia.
Details
| Lead sponsor | University of North Carolina, Chapel Hill |
|---|---|
| Phase | Phase 1 |
| Status | RECRUITING |
| Enrolment | 16 |
| Start date | 2024-07-26 |
| Completion | 2028-11 |
Conditions
- Hypoxic-Ischemic Encephalopathy
Interventions
- Caffeine citrate 20 mg/kg
- Caffeine citrate 30 mg/kg
Primary outcomes
- Apparent Caffeine Clearance — 7 samples will be collected after the first dose of study drug and up to 72 hours after final dose of study drug
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 . - Volume of Distribution of Caffeine — 7 samples will be collected after the first dose of study drug and up to 72 hours after final dose of study drug
Caffeine concentrations will be used to calculate population estimates of volume of distribution with inter-individual variability and residual variability.
Countries
United States