RecruitingHypoxic-Ischemic Encephalopathy

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

Eligible age

All ages

Accepts

All genders

Locations

11 states

Healthy volunteers

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About this study

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.

Sponsor: ReAlta Life Sciences, Inc.

You may qualify if…

✓ 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 \[CPAP\]).

You may not qualify if…

✕ 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).