Cool Prime Study for Mild HIE
This study is looking at how different treatments affect babies born with mild Hypoxic Ischemic Encephalopathy (HIE), a condition where the brain doesn't get enough oxygen or blood flow around birth. Researchers want to compare two approaches: usual care (Normothermia), which keeps the baby's body temperature normal, and Whole body therapeutic hypothermia, which cools the baby's body for 72 hours. The goal is to see which treatment leads to better brain development at around two years of age and to understand any side effects of cooling. About 460 infants will be included. To join, infants must be born at 36 weeks or more and show signs of mild encephalopathy within 6 hours of birth.
- Study design
- This is an observational study involving about 460 infants. It compares two existing treatment approaches based on standard practices at different hospitals.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed up until they are 22-26 months old to measure their neurodevelopmental outcomes.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Cool Prime Comparative Effectiveness Study for Mild HIE
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Lina Chalak, MD · PRINCIPAL_INVESTIGATOR · University of Texas Southwestern Medical Center
Who to contact
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What this trial measures
- Effectiveness of normothermia in infants as measured by Composite Bayley IV score22-26 months of age.
Effectiveness of normothermia in infants is measured by Composite Bayley IV score scale, which is. an extensive formal developmental assessment tool for diagnosing developmental delays in early childhood. Possible scores range from 55- 120 where lower scores indicate worse outcome.