Dose Optimization of Caffeine for HIE

Running, not enrolling · Phase 1

Conditions studied: Hypoxic-Ischemic Encephalopathy

In brief

This is a phase Ib, open-label, dose-validating and safety study of caffeine in neonates with hypoxic-ischemic encephalopathy (HIE) undergoing therapeutic hypothermia.

Key facts

Study ID

NCT06448780

Run by

University of North Carolina, Chapel Hill

People needed

16

Starts

2024-07-26

Expected to finish

2028-07-01

Last updated by the study team

2026-06-18

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

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

Where it is running

• The University of North Carolina at Chapel Hill Newborn Critical Care Center — Chapel Hill, North Carolina, United States
• Novant Health New Hanover Regional Medical Center — Wilmington, North Carolina, United States

Full record on ClinicalTrials.gov

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