Should mildly Brain-Injured newborns be cooled? major trial aims to find out
NCT ID NCT04621279
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether cooling therapy (lowering body temperature for 72 hours) helps babies born with mild brain injury from oxygen loss, compared to standard care without cooling. Researchers will track 460 newborns' development at age 2 and monitor side effects. The goal is to see if cooling improves long-term brain health and is safe for these infants.
What this could mean
Our plain-language read of the trial. This is informational only — not medical advice or a prediction.
- Active substance
- Whole body therapeutic hypothermia (cooling therapy) or normothermia (usual care)
- What this could lead to
- If cooling works better than usual care, it could become a standard treatment to improve brain development in babies with mild HIE.
- What could go wrong
- This is a mid-stage trial with 460 babies, so results may not apply to all. Cooling has known risks like bleeding or infection, and it may not improve outcomes over simple monitoring.
This is an AI summary of the original study and may miss details. Read our disclaimer.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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University of Texas Southwestern Medical Center
RECRUITINGDallas, Texas, 75208, United States