RECRUITING

Dose Optimization of Caffeine for HIE

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Conditions

Hypoxic-Ischemic Encephalopathycaffeine citrate

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Dose Optimization of Caffeine in Neonates With Hypoxic-Ischemic Encephalopathy

Quick Facts

Study Start:2024-07-26
Study Completion:2028-11
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06448780

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.

Ages Eligible for Study:Not specified to 24 Hours
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Documented informed consent from parent or guardian
  2. * ≥ 36 weeks gestational age at birth
  3. * Receiving therapeutic hypothermia for a diagnosis of HIE
  4. * Intravenous (IV) access
  5. * Postnatal age \< 24 hours
  1. * Receiving \> 1 anti-epileptic drug for seizures
  2. * Sustained (\>4 hours) heart rate \> 180 beats per minute
  3. * Known major congenital anomaly

Contacts and Locations

Study Contact

Wesley M Jackson, MD, MPH
CONTACT
984-215-3449
wesley.jackson@unc.edu

Principal Investigator

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

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: University of North Carolina, Chapel Hill

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-26
Study Completion Date2028-11

Study Record Updates

Study Start Date2024-07-26
Study Completion Date2028-11

Terms related to this study

Keywords Provided by Researchers

  • caffeine citrate

Additional Relevant MeSH Terms

  • Hypoxic-Ischemic Encephalopathy