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Methylxanthine

Caffeine for Newborn Brain Injury

Phase 1
Recruiting
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
≥ 36 weeks gestational age at birth
Postnatal age < 24 hours
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
No Placebo-Only Group

Summary

This trial is testing different doses of caffeine in newborn babies with a brain injury caused by lack of oxygen and blood flow. The babies are also receiving cooling therapy.

Who is the study for?
This trial is for newborns born at or after 36 weeks of pregnancy with brain injuries due to lack of oxygen (HIE) who are being treated with therapeutic cooling. They must be less than 24 hours old and have IV access. Babies with very fast heart rates, major birth defects, or on multiple seizure medications cannot join.
What is being tested?
The study tests two different doses of caffeine citrate (20 mg/kg and 30 mg/kg) in these babies to find the best dose and check for safety. It's an early-phase trial where all participants receive the drug openly without a comparison group.
What are the potential side effects?
Possible side effects from caffeine treatment may include increased heart rate, sleep disturbances, digestive issues, jitteriness, and rarely seizures. The exact side effects in this vulnerable population will be closely monitored.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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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.
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I am undergoing cooling treatment for brain injury due to lack of oxygen.

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
Apparent Caffeine Clearance
Volume of Distribution of Caffeine
Secondary study objectives
Number of Participants with Abnormal MRI Brain Finding Score
Number of Participants with Death or Neurodevelopmental Impairment
Number of Participants with Pre-Specified Adverse Events

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Active Control
Group I: Lower loading dose (20 mg/kg)Active Control1 Intervention
Within 24 hours after delivery, participants will receive a loading dose of 20 mg/kg caffeine citrate IV.
Group II: Higher loading dose (30 mg/kg)Active Control1 Intervention
Within 24 hours after delivery, participants will receive a loading dose of 30 mg/kg caffeine citrate IV.

Find a Location

Who is running the clinical trial?

University of North Carolina, Chapel HillLead Sponsor
1,557 Previous Clinical Trials
4,298,553 Total Patients Enrolled
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
2,055 Previous Clinical Trials
2,731,870 Total Patients Enrolled
Wesley M Jackson, MD, MPHPrincipal InvestigatorUniversity of North Carolina, Chapel Hill
1 Previous Clinical Trials
17 Total Patients Enrolled
~11 spots leftby Dec 2026
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