Actively Recruiting
Led by University of North Carolina, Chapel Hill · Updated on 2026-04-07
16
Participants Needed
2
Research Sites
100 weeks
Total Duration
U
University of North Carolina, Chapel Hill
Lead Sponsor
E
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborating Sponsor
Researchers are evaluating caffeine citrate dosing in newborns diagnosed with hypoxic-ischemic encephalopathy (HIE) who are undergoing therapeutic hypothermia. This phase Ib open-label study aims to validate a previously developed population pharmacokinetic model for caffeine and determine optimal dosing for these neonates to support their treatment during this critical condition. Participants will receive an intravenous loading dose of caffeine citrate within 24 hours after delivery, either 20 mg/kg or 30 mg/kg, followed by two daily intravenous doses of 10 mg/kg caffeine citrate. The study compares these two dosing regimens to assess their effects and pharmacokinetics in this vulnerable patient group. Throughout the study, up to seven blood samples will be collected from each participant after the initial caffeine dose and up to 72 hours after the final dose to measure caffeine clearance and distribution volume. Researchers will also monitor safety by recording adverse events from the first dose to seven days after the final dose, assess brain MRI findings during initial hospitalization, and evaluate neurodevelopmental outcomes up to 24 months of age. Participation includes close medical monitoring and follow-up assessments over time.
CONDITIONS
Dose Optimization of Caffeine for HIE
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Complete this quick 3-step screening to check your eligibility
Duration - Up to 24 hours after birth
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Duration - Up to 7 days
Participants receive a loading dose of caffeine citrate IV followed by two daily doses of caffeine citrate IV to optimize dosing for hypoxic-ischemic encephalopathy.
Daily visits for dosing and monitoring during treatment
Duration - Up to 24 months
Participants are monitored for adverse events, brain MRI findings during initial hospitalization, and neurodevelopmental outcomes up to 24 months of age.
Approximately 3 to 5 visits during initial hospitalization and periodic follow-up visits up to 24 months
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
W
Wesley M Jackson, MD, MPH
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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