Actively Recruiting
Dose Optimization of Caffeine for HIE
Led by University of North Carolina, Chapel Hill · Updated on 2026-04-07
16
Participants Needed
2
Research Sites
222 weeks
Total Duration
On this page
Sponsors
U
University of North Carolina, Chapel Hill
Lead Sponsor
E
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a phase Ib, open-label, dose-validating and safety study of caffeine in neonates with hypoxic-ischemic encephalopathy (HIE) undergoing therapeutic hypothermia.
CONDITIONS
Official Title
Dose Optimization of Caffeine for HIE
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Documented informed consent from parent or guardian
- At least 36 weeks gestational age at birth
- Receiving therapeutic hypothermia for a diagnosis of hypoxic-ischemic encephalopathy
- Has intravenous (IV) access
- Postnatal age less than 24 hours
You will not qualify if you...
- Receiving more than one anti-epileptic drug for seizures
- Sustained heart rate over 180 beats per minute for more than 4 hours
- Known major congenital anomaly
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
The University of North Carolina at Chapel Hill Newborn Critical Care Center
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
2
Novant Health New Hanover Regional Medical Center
Wilmington, North Carolina, United States, 28401
Actively Recruiting
Research Team
W
Wesley M Jackson, MD, MPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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