Dose Optimization of Caffeine for HIE

Part of paid clinical trials in Chapel Hill, North Carolina.

Sponsor
University of North Carolina, Chapel Hill
Study ID
NCT06448780
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Hypoxic-Ischemic Encephalopathy

Eligibility Criteria

Sex
ALL
Age
N/A - 24 Hours
Healthy Volunteers
Not accepted

Interventions

  • Caffeine citrate 20 mg/kg — DRUG
    Following loading dose of 20 mg/kg of caffeine citrate IV, participants will receive 2 daily doses of 10 mg/kg caffeine citrate IV.
  • Caffeine citrate 30 mg/kg — DRUG
    Following loading dose of 30 mg/kg of caffeine citrate IV, participants will receive 2 daily doses of 10 mg/kg caffeine citrate IV.

Study Details

This is a phase Ib, open-label, dose-validating and safety study of caffeine in neonates with hypoxic-ischemic encephalopathy (HIE) undergoing therapeutic hypothermia.

Key Dates

Start date
Jul 26, 2024
Status verified
Feb 2026
Primary completion
Dec 31, 2026
Completion
Nov 30, 2028

Study Design

Enrollment
16 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Apparent Caffeine Clearance [ Time Frame: 7 samples will be collected after the first dose of study drug and up to 72 hours after final dose of study drug ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
The University of North Carolina at Chapel Hill Newborn Critical Care CenterChapel HillNorth Carolina27599
Wesley M Jackson, MD, MPH
[email protected]
984-215-3449
Novant Health New Hanover Regional Medical CenterWilmingtonNorth Carolina28401
Sheri Carroll, MD
[email protected]
910-667-3251

Find similar trials in Chapel Hill, NC

By research site
The University of North Carolina at Chapel Hill Newborn Critical Care Center· Chapel Hill, NCNovant Health New Hanover Regional Medical Center· Wilmington, NC

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