๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-08-12

Dose Optimization of Caffeine for HIE (NCT06448780)

Dose Optimization of Caffeine in Neonates With Hypoxic-Ischemic Encephalopathy

๐Ÿ”ต Active, Not Recruiting Phase1 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: University of North Carolina, Chapel Hill

๐Ÿฉบ 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

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ 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

๐Ÿ’ฐ 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.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—