NCT06448780

Dose Optimization of Caffeine for HIE

Dose Optimization of Caffeine in Neonates With Hypoxic-Ischemic Encephalopathy

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (estimated)
• Sponsor: University of North Carolina, Chapel Hill · Academic / Other
• Sex: All
• Age: 24 Hours
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Hypoxic-Ischemic Encephalopathy

Interventions

Type	Name	Description
DRUG	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.
DRUG	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.

Timeline

• Start date: 2024-07-26
• Primary completion: 2026-12-01
• Completion: 2028-11-01
• First posted: 2024-06-07
• Last updated: 2026-04-07

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study