Caffeine for Hypoxic Ischemic Encephalopathy (NCT06855108)
Caffeine for Hypoxic Ischemic Encephalopathy (CHIME Trial)
🩺 Plain-English Summary (8th-Grade Level)
CHIME is a randomized, parallel-arm, double-blind, placebo-controlled trial focused on infants with hypoxic ischemic encephalopathy (HIE). The trial will recruit neonates who are diagnosed with HIE within six hours after birth based on physiologic criteria (acidosis noted on an umbilical cord or early \[\<1 hour\] postnatal blood sample) and neurologic criteria (modified Sarnat exam consistent with encephalopathy). Following informed consent, and by six hours after birth, neonates with HIE will be randomized to one of two treatment arms and subsequently receive one 20 mg/kg dose of oral caffeine followed by two additional 10 mg/kg doses at 24-hour intervals or placebo of the same regimen (three total doses). The goal of this clinical trial is to compare the incidence of all-cause mortality OR moderate to severe neurodevelopmental impairment (NDI) at 18-22 months between neonates with HIE who are randomized to oral caffeine or placebo. Our hypothesis is that neonates with HIE who receive oral caffeine will have 10% lower incidence of all-cause mortality or moderate to severe NDI at 18-22 months compared to placebo.
Who can join: Review the eligibility criteria below.
Location: ICDDR,B — Saidpur
Age range: Not specified to 6 Hours
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (7 Sites)
- ICDDR,B — Saidpur,
- Kinshasa School of Public Health — Kinshasa,
- Institute of Nutrition of Central America And Panama (INCAP) — Chimaltenango,
- KLE University's J N Medical College — Belagavi,
- Lata Medical Research Foundation — Nagpur,
- Aga Khan University — Karachi,
- University Teaching Hospital — Lusaka,
📞 Contact the Study Coordinator
Phone: (919) 541-6000
Email: wagner@rti.org
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 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 § 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 (HIE)
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.