๐๏ธ Verified NIH Record โข Updated 2026-08-12
Dose Optimization of Caffeine for HIE (NCT06448780)
Dose Optimization of Caffeine in Neonates With Hypoxic-Ischemic Encephalopathy
๐ต Active, Not Recruiting Phase1 ๐ Investigational Drug / Biologic Sponsor: University of North Carolina, Chapel Hill
๐ฉบ Plain-English Summary (8th-Grade Level)
This is a phase Ib, open-label, dose-validating and safety study of caffeine in neonates with hypoxic-ischemic encephalopathy (HIE) undergoing therapeutic hypothermia.
Who can join: Review the eligibility criteria below.
Location: The University of North Carolina at Chapel Hill Newborn Critical Care Center โ Chapel Hill, North Carolina
Age range: Not specified to 24 Hours
๐งช Interventions in This Study
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria โ
๐ All Participating Trial Locations (2 Sites)
- The University of North Carolina at Chapel Hill Newborn Critical Care Center โ Chapel Hill, North Carolina
- Novant Health New Hanover Regional Medical Center โ Wilmington, North Carolina
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Hypoxic-Ischemic Encephalopathy
- Healthy Little Eyes โ Madison, Wisconsin
- A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of RLS-0071 in Newborns With Moderate or Severe Hypoxic-Ischemic Encephalopathy Undergoing Therapeutic Hypothermia โ Little Rock, Arkansas
- Evaluating a Wireless NIRS Device in the Neonatal Intensive Care Unit โ Montreal, Quebec
Explore by condition: All Hypoxic-Ischemic Encephalopathy clinical trials
๐ก How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.