RECRUITING

Dose Optimization of Caffeine for HIE

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.

Conditions

Hypoxic-Ischemic Encephalopathy
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Related Conditions:

Hypoxic-Ischemic Encephalopathy

Study Overview

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Study Details

Study overview

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

Dose Optimization of Caffeine in Neonates With Hypoxic-Ischemic Encephalopathy

Dose Optimization of Caffeine for HIE

Condition
Hypoxic-Ischemic Encephalopathy
Intervention / Treatment

-

Contacts and Locations

Chapel Hill

The University of North Carolina at Chapel Hill Newborn Critical Care Center, Chapel Hill, North Carolina, United States, 27599

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

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

Ages Eligible for Study

to 24 Hours

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of North Carolina, Chapel Hill,

Wesley M Jackson, MD, MPH, PRINCIPAL_INVESTIGATOR, University of North Carolina, Chapel Hill

Study Record Dates

2028-11