Actively Recruiting

Phase 2
Age: 0 - 10Hours
All Genders
NCT05778188

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of RLS-0071 in Newborns With Moderate or Severe Hypoxic-Ischemic Encephalopathy Undergoing Therapeutic Hypothermia

Led by ReAlta Life Sciences, Inc. · Updated on 2026-04-13

70

Participants Needed

15

Research Sites

279 weeks

Total Duration

On this page

Sponsors

R

ReAlta Life Sciences, Inc.

Lead Sponsor

P

Premier Research

Collaborating Sponsor

AI-Summary

What this Trial Is About

Hypoxic-ischemic encephalopathy (HIE) affects approximately 4,000 to 12,000 persons annually in the United States. Mortality from HIE has been reported up to 60%, with at least 25% of survivors left with significant neurocognitive disability. Despite this vital unmet medical need, no pharmacological adjunct or alternative therapy has proven beneficial in improving outcomes in neonatal HIE. RLS-0071 is a novel peptide being developed for the treatment of neonatal HIE. This study is designed to evaluate the safety and tolerability of RLS-0071 in the treatment of newborns with moderate or severe HIE.

CONDITIONS

Official Title

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of RLS-0071 in Newborns With Moderate or Severe Hypoxic-Ischemic Encephalopathy Undergoing Therapeutic Hypothermia

Who Can Participate

Age: 0 - 10Hours
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Born at or after 36 weeks gestation
  • Experienced a sentinel event before delivery such as abruption, tight nuchal cord, uterine rupture, profound bradycardia, shoulder dystocia, or cord prolapse
  • Have moderate or severe encephalopathy with at least one risk factor (low blood pH, low APGAR score, or need for assisted ventilation) and one clinical sign (moderate/severe encephalopathy or seizures)
  • Eligible to receive therapeutic hypothermia
  • Whole-body cooling started before 6 hours of age (passive cooling allowed before active cooling)
  • Product of a singleton pregnancy
  • Parent or legal guardian has provided written informed consent
Not Eligible

You will not qualify if you...

  • Cannot start the first dose of RLS-0071 within 10 hours of birth
  • Known major congenital or chromosomal abnormalities
  • Severe growth restriction with birth weight 1800 g or less
  • Prenatal brain abnormalities or hydrocephalus
  • Head circumference less than 30 cm
  • APGAR score less than 2 at 10 minutes, if available
  • Suspected overwhelming sepsis or congenital infection
  • Severe hypotension not responding to treatment
  • Severe hypoxia despite 100% oxygen and additional treatments or requiring ECMO
  • Severe bleeding due to disseminated intravascular coagulation
  • Neonatal encephalopathy caused by reasons other than perinatal hypoxia
  • Moribund infants with care withdrawal being considered
  • Suspected or confirmed fetal alcohol syndrome or substance withdrawal seizures
  • Any condition considered by the investigator to make participation unsafe, including severe intracranial hemorrhage

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 15 locations

1

Study Site 016

Little Rock, Arkansas, United States, 72202

Actively Recruiting

2

Study Site 013

Orange, California, United States, 92868

Actively Recruiting

3

Study Site 020

San Diego, California, United States, 92037

Actively Recruiting

4

Study Site 019

San Diego, California, United States, 92123

Actively Recruiting

5

Study Site 001

Gainesville, Florida, United States, 32608

Actively Recruiting

6

Study Site 018

Miami, Florida, United States, 33143

Actively Recruiting

7

Study Site 010

Orlando, Florida, United States, 32803

Actively Recruiting

8

Study Site 014

Indianapolis, Indiana, United States, 46202

Actively Recruiting

9

Study Site 012

Lexington, Kentucky, United States, 40536

Withdrawn

10

Study Site 002

Boston, Massachusetts, United States, 02115

Actively Recruiting

11

Study Site 006

St Louis, Missouri, United States, 63110

Actively Recruiting

12

Study Site 003

Durham, North Carolina, United States, 27710

Actively Recruiting

13

Study Site 021

Cleveland, Ohio, United States, 44195

Actively Recruiting

14

Study Site 022

Fort Worth, Texas, United States, 76104

Actively Recruiting

15

Study Site 005

Morgantown, West Virginia, United States, 26506

Actively Recruiting

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Research Team

L

Lori Upham

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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