RecruitingPhase 1

Dose Optimization of Caffeine for HIE

United States16 participantsStarted 2024-07-26

Plain-language 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.

Who can participate

Age range24 Hours

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Apparent Caffeine Clearance

Timeframe: 7 samples will be collected after the first dose of study drug and up to 72 hours after final dose of study drug

Volume of Distribution of Caffeine

Timeframe: 7 samples will be collected after the first dose of study drug and up to 72 hours after final dose of study drug

Trial details

NCT IDNCT06448780

SponsorUniversity of North Carolina, Chapel Hill

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12

Contact for this trial

Wesley M Jackson, MD, MPH

984-215-3449 wesley.jackson@unc.edu

View on ClinicalTrials.gov More Hypoxic-Ischemic Encephalopathy trials