Dose Optimization of Caffeine in Neonates With Hypoxic-Ischemic Encephalopathy
Status: Recruiting
Location: See location...
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
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)