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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.
In a previous phase I trial (NCT03913221), the investigators characterized the pharmacokinetics (PK) of caffeine in the setting of HIE and therapeutic hypothermia using a population PK model. This is an open-label study of caffeine citrate in neonates with HIE to validate the population PK model and determine optimal dosing for HIE.
Age
0 - 0 years
Sex
ALL
Healthy Volunteers
No
The University of North Carolina at Chapel Hill Newborn Critical Care Center
Chapel Hill, North Carolina, United States
Novant Health New Hanover Regional Medical Center
Wilmington, North Carolina, United States
Start Date
July 26, 2024
Primary Completion Date
December 1, 2026
Completion Date
November 1, 2028
Last Updated
March 3, 2026
16
ESTIMATED participants
Caffeine citrate 20 mg/kg
DRUG
Caffeine citrate 30 mg/kg
DRUG
Lead Sponsor
University of North Carolina, Chapel Hill
Collaborators
NCT05901688
NCT05836610
Data Source & Attribution
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