Evaluating a new treatment for newborns with brain injury from lack of oxygen

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial assesses the safety, tolerability, pharmacokinetics, and preliminary efficacy of RLS-0071, a novel peptide, in newborns diagnosed with moderate or severe hypoxic-ischemic encephalopathy (HIE) undergoing therapeutic hypothermia. The study is designed as a Phase 2, two-stage, multisite, randomized, double-blind, placebo-controlled trial. Participants will receive either RLS-0071 or a placebo for 72 hours, followed by long-term observation until they reach 24 months of age. Safety evaluations will be conducted throughout the study to monitor any adverse effects and the drug's pharmacokinetics.

Why it matters

Who can join: the full rules

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 to 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 from criterion (a) and one clinical sign of encephalopathy from 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 2-5 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. Participant'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 is being considered.
13. Suspected or confirmed fetal alcohol syndrome or suspected substance withdrawal seizures.
14. Any other condition that the investigator may consider would make the participant ineligible for the study or place the participant at an unacceptable risk, including a clinically significant (eg, Grade 3 or 4) intracranial hemorrhage.

Where it's running

• Study Site 016
  Little Rock, Arkansas, United States Recruiting
• Study Site 013
  Orange, California, United States Recruiting
• Study Site 020
  San Diego, California, United States Recruiting
• Study Site 019
  San Diego, California, United States Recruiting
• Study Site 027
  Aurora, Colorado, United States Recruiting
• Study Site 001
  Gainesville, Florida, United States Recruiting

Study contacts

• Study coordinator: Lori Upham
• Email: Lupham@realtals.com
• Phone: 757-901-0331

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.