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Caffeine for Brain Injury

Phase 1
Waitlist Available
Led By Wesley M Jackson, MD, MPH
Research Sponsored by University of North Carolina, Chapel Hill
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Receiving therapeutic hypothermia for a diagnosis of HIE
≥ 36 weeks gestational age at birth
Must not have
Receiving > 1 anti-epileptic drug for seizures
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18-24 months of age
Awards & highlights

Summary

This trial will study whether adding caffeine to therapeutic hypothermia improves neurodevelopmental outcomes in infants with HIE.

Who is the study for?
This trial is for newborns born at or after 36 weeks of pregnancy, diagnosed with brain injury due to oxygen deprivation (HIE), and are undergoing cooling therapy. They must have IV access and be less than 24 hours old. Babies on multiple seizure medications, with very high heart rates, major birth defects, or other conditions making them unsuitable for the study can't participate.
What is being tested?
The study tests caffeine as an additional treatment to improve brain development outcomes in infants with HIE. Two different doses of Caffeine Citrate (5 mg/kg and 10 mg/kg) are being studied to see how they're processed by the body, their safety, and early signs of effectiveness.
What are the potential side effects?
Potential side effects from Caffeine Citrate may include increased heart rate, sleep disturbances, feeding difficulties, jitteriness or nervousness in infants; however specific side effects will be closely monitored given this is a phase I trial assessing safety.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am undergoing cooling treatment for brain injury due to lack of oxygen.
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I was born at or after 36 weeks of pregnancy.
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My baby is less than 24 hours old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am taking more than one medication for seizures.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18-24 months of age
This trial's timeline: 3 weeks for screening, Varies for treatment, and 18-24 months of age for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Area Under Plasma Concentration-time at Time t (AUC0-t) for Caffeine
Secondary study objectives
Incidence of seizures and necrotizing enterocolitis, which are potential complications of caffeine exposure
Number of participants with a Bayley Scales of Infant Development (BSID-III) cognitive, language, or motor composite score < 85
Number of participants with abnormal MRI brain findings based on NICHD Neonatal Research Network score

Trial Design

2Treatment groups
Active Control
Group I: Low Dose Caffeine (5 mg/kg)Active Control1 Intervention
Within 24 hours of delivery, participants will receive low dose administration of Caffeine citrate.
Group II: High Dose Caffeine (10 mg/kg)Active Control1 Intervention
Within 24 hours of delivery, participants will receive high dose administration of Caffeine citrate.

Find a Location

Who is running the clinical trial?

University of North Carolina, Chapel HillLead Sponsor
1,543 Previous Clinical Trials
4,249,025 Total Patients Enrolled
Thrasher Research FundOTHER
132 Previous Clinical Trials
94,395 Total Patients Enrolled
Wesley M Jackson, MD, MPHPrincipal InvestigatorUniversity of North Carolina, Chapel Hill
1 Previous Clinical Trials
16 Total Patients Enrolled

Media Library

Low Dose Caffeine (5 mg/kg) Clinical Trial Eligibility Overview. Trial Name: NCT03913221 — Phase 1
Hypoxic-Ischemic Encephalopathy Research Study Groups: Low Dose Caffeine (5 mg/kg), High Dose Caffeine (10 mg/kg)
Hypoxic-Ischemic Encephalopathy Clinical Trial 2023: Low Dose Caffeine (5 mg/kg) Highlights & Side Effects. Trial Name: NCT03913221 — Phase 1
Low Dose Caffeine (5 mg/kg) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03913221 — Phase 1
~3 spots leftby Sep 2025
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