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New drug could protect Babies' brains after birth complications

NCT ID NCT05778188

Recruiting now Disease control Sponsor: ReAlta Life Sciences, Inc. Source: ClinicalTrials.gov ↗

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a drug called RLS-0071 in newborns who have brain damage from lack of oxygen during birth. The babies also receive standard cooling therapy. The goal is to see if the drug is safe and may help reduce brain injury. About 70 babies will take part, and they will be followed for up to 2 years.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance
RLS-0071 (a peptide drug given by infusion)
What this could lead to
If it works, this could point toward a treatment that reduces brain damage and improves outcomes for newborns with HIE.
What could go wrong
This is an early phase 2 trial with only 70 babies, so results are preliminary. The drug may not prove effective or could have side effects.

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.

brain hypoxia - ischemia perinatal asphyxia

As listed by the trial registrant

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

HYPOXIC-ISCHEMIC ENCEPHALOPATHY

Contacts and locations

Locations

  • Study Site 001

    RECRUITING

    Gainesville, Florida, 32608, United States

  • Study Site 002

    RECRUITING

    Boston, Massachusetts, 02115, United States

  • Study Site 003

    RECRUITING

    Durham, North Carolina, 27710, United States

  • Study Site 005

    RECRUITING

    Morgantown, West Virginia, 26506, United States

  • Study Site 006

    RECRUITING

    St Louis, Missouri, 63110, United States

  • Study Site 010

    RECRUITING

    Orlando, Florida, 32803, United States

  • Study Site 012

    WITHDRAWN

    Lexington, Kentucky, 40536, United States

  • Study Site 013

    RECRUITING

    Orange, California, 92868, United States

  • Study Site 014

    RECRUITING

    Indianapolis, Indiana, 46202, United States

  • Study Site 016

    RECRUITING

    Little Rock, Arkansas, 72202, United States

  • Study Site 018

    RECRUITING

    Miami, Florida, 33143, United States

  • Study Site 019

    RECRUITING

    San Diego, California, 92123, United States

  • Study Site 020

    RECRUITING

    San Diego, California, 92037, United States

  • Study Site 021

    RECRUITING

    Cleveland, Ohio, 44195, United States

  • Study Site 022

    RECRUITING

    Fort Worth, Texas, 76104, United States

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