Dose Optimization of Caffeine in Neonates With Hypoxic-Ischemic Encephalopathy
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY
This is a phase Ib, open-label, dose-validating and safety study of caffeine in neonates with hypoxic-ischemic encephalopathy (HIE) undergoing therapeutic hypothermia.
Eligibility
Participation Requirements
Sex: All
Maximum Age: 1 day
Healthy Volunteers: f
View:
• 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
Locations
United States
North Carolina
The University of North Carolina at Chapel Hill Newborn Critical Care Center
RECRUITING
Chapel Hill
Novant Health New Hanover Regional Medical Center
RECRUITING
Wilmington
Contact Information
Primary
Wesley M Jackson, MD, MPH
wesley.jackson@unc.edu
984-215-3449
Time Frame
Start Date: 2024-07-26
Estimated Completion Date: 2028-11
Participants
Target number of participants: 16
Treatments
Active_comparator: Lower loading dose (20 mg/kg)
Within 24 hours after delivery, participants will receive a loading dose of 20 mg/kg caffeine citrate IV.
Active_comparator: Higher loading dose (30 mg/kg)
Within 24 hours after delivery, participants will receive a loading dose of 30 mg/kg caffeine citrate IV.
Related Therapeutic Areas
Sponsors
Leads: University of North Carolina, Chapel Hill
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)