ClinicalTrialsFinder
RecruitingPhase 1NCT06448780

Dose Optimization of Caffeine for HIE

Dose Optimization of Caffeine in Neonates With Hypoxic-Ischemic Encephalopathy

Sponsor

University of North Carolina, Chapel Hill

Enrollment

16 participants

Start Date

Jul 26, 2024

Study Type

INTERVENTIONAL

Conditions

Hypoxic-ischemic encephalopathy.

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

Max Age: 24 Hours

Inclusion Criteria5

  • 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 Criteria3

  • Receiving > 1 anti-epileptic drug for seizures
  • Sustained (>4 hours) heart rate > 180 beats per minute
  • Known major congenital anomaly

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGCaffeine 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.

DRUGCaffeine 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.

Locations(2)

The University of North Carolina at Chapel Hill Newborn Critical Care Center

Chapel Hill, North Carolina, United States

Novant Health New Hanover Regional Medical Center

Wilmington, North Carolina, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06448780

Related Trials

Individual Cerebral Hemodynamic Oxygenation Relationships (ICHOR 1)

NCT061953451 location

Hydrocortisone Therapy Optimization During Hypothermia Treatment in Asphyxiated Neonates

NCT058366101 location

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of RLS-0071 in Newborns With Moderate or Severe Hypoxic-Ischemic Encephalopathy Undergoing Therapeutic Hypothermia

NCT0577818815 locations

Intensive Multimodal Neurorehabilitation Targeting Neuroplasticity in Pediatric Neurodevelopmental and Chromosomal Disorders

NCT074930961 location

Assess Safety and Efficacy of Sovateltide in Hypoxic-ischemic Encephalopathy

NCT055143404 locations