Dose Optimization of Caffeine in Neonates With Hypoxic-Ischemic Encephalopathy
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.
Description
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.
Eligibility
- Age range
- Up to 24 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Documented informed consent from parent or guardian * ≥ 36 weeks gestational age at birth * Receiving therapeutic hypothermia for a diagnosis of HIE * Intravenous (IV) access * Postnatal age \< 24 hours Exclusion Criteria: * Receiving \> 1 anti-epileptic drug for seizures * Sustained (\>4 hours) heart rate \> 180 beats per minute * Known major congenital anomaly
Interventions
- DrugCaffeine 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.
- DrugCaffeine 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 CenterChapel Hill, North Carolina
- Novant Health New Hanover Regional Medical CenterWilmington, North Carolina