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New drug could protect Babies' brains after birth complications

NCT ID NCT05778188

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 70 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2023

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Up to 10 hours

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. ≥ 36 weeks gestation. 2. Sentinel event prior to delivery such as abruption, tight nuchal cord, uterine rupture, profound bradycardia, shoulder dystocia, or cord prolapse or other acute event likely attributable for newborn depression at delivery or an acute change in the fetal status with a clinical presentation consistent with an acute sentinel event with no clearly defined etiology. 3. Moderate or severe encephalopathy based on at least one risk of encephalopathy criterion (a) and one clinical signs of encephalopathy criterion (b): 1. Risk of encephalopathy (either): * Blood gas drawn within 1 hour of birth, either arterial blood gas (ABG) or venous blood gas (VBG) (cord or infant) with pH ≤ 7.0 OR base deficit ≥ 16 mmol/L. OR * appearance, pulse, grimace, activity, and respiration (APGAR) score ≤ 5 at 10 minutes OR * The infant required assisted ventilation ≥ 10 minutes after birth (ie, endotracheal, mask ventilation, or continuous positive airway pressure \[CPAP\]). 2. Clinical signs of encephalopathy (either/both): * Moderate/Severe encephalopathy on National Institute of Child Health and Human Development assessment. * Evidence of seizures (clinical and/or electroencephalogram). 4. Be eligible to receive therapeutic hypothermia. 5. Active whole-body cooling to be started prior to 6 hours of age (passive cooling is permitted prior to active whole body cooling). 6. Product of a singleton pregnancy. 7. Written informed consent obtained from parent or legal guardian. Exclusion Criteria: 1. Inability to enroll in the study and initiate the first dose of RLS-0071 within 10 hours of life. 2. Known major congenital and/or chromosomal abnormality(ies). 3. Severe growth restriction (birth weight ≤ 1800 g). 4. Prenatal diagnosis of brain abnormality or hydrocephalus. 5. Patient's head circumference is \< 30 cm. 6. 10-minute APGAR score \< 2, if available. 7. Infants suspected of overwhelming sepsis or congenital infection based on the Investigator's clinical consideration at the time of enrollment. 8. Persistent severe hypotension unresponsive to inotropic support (requiring \>2 inotropes, not inclusive of hydrocortisone). 9. Persistent severe hypoxia in the setting of 100% fraction of inspired oxygen (FiO₂) and unresponsive to nitric oxide or requiring extracorporeal membrane oxygenation (ECMO). 10. Severe disseminated intravascular coagulation with clinical bleeding. 11. Neonatal encephalopathy believed to be due to a cause other than perinatal hypoxia (ie, other than HIE). 12. Moribund infants for whom withdrawal of care being considered. 13. Suspected or confirmed fetal alcohol syndrome or suspected substance withdraw seizures. 14. Any other condition that the investigator may consider would make the patient ineligible for the study or place the patient at an unacceptable risk (Note: this criterion would include a clinically significant \[eg, Grade 3 or 4\] intracranial hemorrhage).

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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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    14 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

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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Other studies related to the condition(s) this trial covers.