Clinical Research Directory
Browse clinical research sites, groups, and studies.
Dose Optimization of Caffeine for HIE
Sponsor: University of North Carolina, Chapel Hill
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.
Official title: Dose Optimization of Caffeine in Neonates With Hypoxic-Ischemic Encephalopathy
Key Details
Gender
All
Age Range
Any - 24 Hours
Study Type
INTERVENTIONAL
Enrollment
16
Start Date
2024-07-26
Completion Date
2028-11
Last Updated
2026-04-07
Healthy Volunteers
No
Conditions
Interventions
Caffeine citrate 20 mg/kg
Following loading dose of 20 mg/kg of caffeine citrate IV, participants will receive 2 daily doses of 10 mg/kg caffeine citrate IV.
Caffeine citrate 30 mg/kg
Following loading dose of 30 mg/kg of caffeine citrate IV, participants will receive 2 daily doses of 10 mg/kg caffeine citrate IV.
Locations (2)
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