Cool Prime Comparative Effectiveness Study for Mild HIE (NCT04621279)
COOLPRIME: Comparative Effectiveness for Cooling Prospectively Infants With Mild Encephalopathy
🩺 Plain-English Summary (8th-Grade Level)
To determine effectiveness of therapy to improve neurodevelopmental outcomes in infants with mild HIE. To determine the adverse effects of Therapeutic Hypothermia (TH) in mild HIE on the neonate and his/her family. Determine heterogeneity of the treatment effect across key subgroups obtained in the first 6 hours after birth prior to the decision to initiate therapy.
Who can join: Review the eligibility criteria below.
Location: University of Texas Southwestern Medical Center — Dallas, Texas
Age range: 36 Weeks
🧪 Interventions in This Study
- Normothermia (PROCEDURE)
- Whole body therapeutic hypothermia (PROCEDURE)
📋 "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 (1 Sites)
- University of Texas Southwestern Medical Center — Dallas, Texas
📞 Contact the Study Coordinator
Phone: (214) 648-3903
Email: lina.chalak@utsouthwestern.edu
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.
Explore by condition: All Mild Hypoxic Ischemic Encephalopathy of Newborn clinical trials
💡 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.