Optic IconOptic Logo
|
SearchCollectionsBenchmarks
Clinical trial

Dose Optimization of Caffeine in Neonates With Hypoxic-Ischemic Encephalopathy

ID
Name
24-0654
Description
This is a phase Ib, open-label, dose-validating and safety study of caffeine in neonates with hypoxic-ischemic encephalopathy (HIE) undergoing therapeutic hypothermia.
Trial arms
Trial start
2024-11-01
Estimated PCD
2026-12-01
Trial end
2028-11-01
Status
Not yet recruiting
Phase
Early phase I
Treatment
Caffeine citrate 20 mg/kg
Following loading dose of 20 mg/kg of caffeine citrate IV, participants will receive 2 daily doses of 10 mg/kg caffeine citrate IV.
Arms:
Lower loading dose (20 mg/kg)
Other names:
Cafcit
Caffeine citrate 30 mg/kg
Following loading dose of 30 mg/kg of caffeine citrate IV, participants will receive 2 daily doses of 10 mg/kg caffeine citrate IV.
Arms:
Higher loading dose (30 mg/kg)
Other names:
Cafcit
Size
16
Primary endpoint
Apparent Caffeine Clearance
7 samples will be collected after the first dose of study drug and up to 72 hours after final dose of study drug
Volume of Distribution of Caffeine
7 samples will be collected after the first dose of study drug and up to 72 hours after final dose of study drug
Eligibility criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Receiving \> 1 anti-epileptic drug for seizures * Sustained (\>4 hours) heart rate \> 180 beats per minute * Known major congenital anomaly
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'The first cohort of 8 infants will receive a lower loading dose of caffeine. Following a safety review, an additional 8 infants will receive a higher loading dose.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 16, 'type': 'ESTIMATED'}}
Updated at
2024-06-10

1 organization

1 product

1 indication

Organization
University of North Carolina, Chapel Hill
Product
Caffeine citrate
Indication
Hypoxic-Ischemic Encephalopathy