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NCT06448780

Dose Optimization of Caffeine for HIE

Active, Not Recruiting
PHASE1Up to 24InterventionalTreatment
University of North Carolina, Chapel Hill
~16 participants
Updated 2026-08-14 on ClinicalTrials.gov
What's tested:Caffeine citrate 20 mg/kgCaffeine citrate 30 mg/kg

At a glance

Recruiting sites
0 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Apparent Caffeine Clearance
Measured over 7 samples will be collected after the first dose of study drug and up to 72 hours after final dose of study drug
+1 more outcome measured

Conditions

Hypoxic-Ischemic Encephalopathy

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Hypoxic Ischemic Encephalopathy

Where it's being run

2 sites across 1 states
North Carolina2

Study leadership

  • Wesley M Jackson, MD, MPH · PRINCIPAL_INVESTIGATOR · University of North Carolina, Chapel Hill

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Receiving \> 1 anti-epileptic drug for seizures
Sustained (\>4 hours) heart rate \> 180 beats per minute
Known major congenital anomaly

What this trial measures

  • Apparent Caffeine Clearance7 samples will be collected after the first dose of study drug and up to 72 hours after final dose of study drug

    Clearance is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Caffeine concentrations will be used to calculate population estimates of caffeine clearance, with inter-individual variabilty and residual variabilty .

  • Volume of Distribution of Caffeine7 samples will be collected after the first dose of study drug and up to 72 hours after final dose of study drug

    Caffeine concentrations will be used to calculate population estimates of volume of distribution with inter-individual variability and residual variability.