Optimizing caffeine dosage for newborns with brain injury
Dose Optimization of Caffeine in Neonates With Hypoxic-Ischemic Encephalopathy
PHASE1 · University of North Carolina, Chapel Hill · NCT06448780
This study is testing different doses of caffeine to see which one is safest and most effective for newborns with brain injury who are being treated with cooling therapy.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 16 (estimated) |
| Ages | N/A to 24 Hours |
| Sex | All |
| Sponsor | University of North Carolina, Chapel Hill (other) |
| Locations | 2 sites (Chapel Hill, North Carolina and 1 other locations) |
| Trial ID | NCT06448780 on ClinicalTrials.gov |
What this trial studies
This phase Ib study investigates the safety and optimal dosing of caffeine citrate in neonates diagnosed with hypoxic-ischemic encephalopathy (HIE) who are undergoing therapeutic hypothermia. Building on previous pharmacokinetic research, this open-label trial aims to validate a population pharmacokinetic model for caffeine in this vulnerable population. The study will administer two different doses of caffeine citrate to determine the most effective and safe dosage for these infants.
Who should consider this trial
Good fit: Ideal candidates are neonates with HIE who are at least 36 weeks gestational age and receiving therapeutic hypothermia.
Not a fit: Patients with major congenital anomalies or those receiving multiple anti-epileptic drugs may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve treatment outcomes for neonates with HIE by optimizing caffeine dosing.
How similar studies have performed: Previous studies have explored caffeine use in similar contexts, but this specific dose optimization approach is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion 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 Exclusion Criteria: * Receiving \> 1 anti-epileptic drug for seizures * Sustained (\>4 hours) heart rate \> 180 beats per minute * Known major congenital anomaly
Where this trial is running
Chapel Hill, North Carolina and 1 other locations
- The University of North Carolina at Chapel Hill Newborn Critical Care Center — Chapel Hill, North Carolina, United States (RECRUITING)
- Novant Health New Hanover Regional Medical Center — Wilmington, North Carolina, United States (RECRUITING)
Study contacts
- Principal investigator: Wesley M Jackson, MD, MPH — University of North Carolina, Chapel Hill
- Study coordinator: Wesley M Jackson, MD, MPH
- Email: wesley.jackson@unc.edu
- Phone: 984-215-3449
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Hypoxic-Ischemic Encephalopathy, caffeine citrate