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.

Disclaimer Read more

This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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Conditions

The condition(s) this trial relates to.

brain hypoxia - ischemia brain ischemia Hypoxia, Brain perinatal asphyxia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Study contacts

  • Contact

    Phone: •••-•••-•••• Email: •••••@•••••

  • Contact

    Phone: •••-•••-•••• Email: •••••@•••••

Locations

  • University of Texas Southwestern Medical Center

    RECRUITING

    Dallas, Texas, 75208, United States

    Contact Phone: •••-•••-•••• Email: •••••@•••••