NCT06448780View on ClinicalTrials.gov

Dose Optimization of Caffeine for HIE

PHASE1RecruitingINTERVENTIONAL
Enrollment

16

Participants

Timeline

Start Date

July 26, 2024

Primary Completion Date

December 31, 2026

Study Completion Date

November 30, 2028

Conditions
Hypoxic-Ischemic Encephalopathy
Interventions
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.

Trial Locations (1)

27599

RECRUITING

The University of North Carolina at Chapel Hill Newborn Critical Care Center, Chapel Hill

All Listed Sponsors
collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

lead

University of North Carolina, Chapel Hill

OTHER