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Dose Optimization of Caffeine for HIE

Dose Optimization of Caffeine for HIE

Recruiting
24 years and younger
All
Phase 1
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  • Simplified (AI rewritten)

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Overview

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

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

Study details
    Hypoxic-Ischemic Encephalopathy

NCT06448780

University of North Carolina, Chapel Hill

15 October 2025

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