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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18-24 months of age
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I am undergoing cooling treatment for brain injury due to lack of oxygen.
Select...
I was born at or after 36 weeks of pregnancy.
Select...
My baby is less than 24 hours old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 18-24 months of age
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18-24 months of age
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Area Under Plasma Concentration-time at Time t (AUC0-t) for Caffeine
Secondary outcome measures
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.
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Who is running the clinical trial?
University of North Carolina, Chapel HillLead Sponsor
1,508 Previous Clinical Trials
4,191,017 Total Patients Enrolled
Thrasher Research FundOTHER
132 Previous Clinical Trials
94,357 Total Patients Enrolled
Wesley M Jackson, MD, MPHPrincipal InvestigatorUniversity of North Carolina, Chapel Hill
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am taking more than one medication for seizures.I am undergoing cooling treatment for brain injury due to lack of oxygen.I was born at or after 36 weeks of pregnancy.Your heart beats very fast for a long time.My baby is less than 24 hours old.You were born with a serious physical abnormality.
Research Study Groups:
This trial has the following groups:- Group 1: Low Dose Caffeine (5 mg/kg)
- Group 2: High Dose Caffeine (10 mg/kg)
Awards:
This trial has 3 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How hazardous is ingesting a measured dosage of caffeine for individuals?
"Because this is an early-stage trial, with limited data supporting safety and efficacy, Low Dose Caffeine (5 mg/kg) scored a 1 on the risk scale."
Answered by AI
Are there any documented precedents of Low Dose Caffeine trials (5 mg/kg) being conducted?
"At present, there are 13 active studies researching the efficacy of 5 mg/kg Low Dose Caffeine. Two trials have advanced to Phase 3. Although many of these studies are being conducted in Chongqing, 121 clinical trial sites across the world are participating in this research initiative."
Answered by AI
How many individuals have joined this clinical trial?
"Affirmative. Records on clinicaltrials.gov demonstrate that this research study is actively recruiting patients since its initial posting on July 12th 2019 and latest edit on September 13th 2022. 18 participants are being recruited from 1 particular site."
Answered by AI
What medical purpose is Low Dose Caffeine (5 mg/kg) usually employed for?
"Low Dose Caffeine (5 mg/kg) is efficacious in treating a variety of symptoms, including respiratory depression, pain and menstrual pains."
Answered by AI
Are new participants still being accepted for this medical experiment?
"Affirmative. Clinicaltrials.gov indicates that this research is presently seeking volunteers, having been initially listed on July 12th 2019 and last updated September 13th 2022. A total of 18 individuals across a single site are being recruited for the trial."
Answered by AI
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