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Tests treatment safety and results for Hypoxic-Ischemic Encephalopathy
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
ClinicalTrials.gov ID: NCT05778188
What this study is testing
What is RLS-0071?
RLS-0071 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for hypoxic-ischemic encephalopathy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages up to 10
You may be able to join if
- ≥ 36 weeks gestation.
- Sentinel event prior to delivery such as abruption, tight nuchal cord, uterine rupture, profound bradycardia, shoulder dystocia, or cord prolapse or...
- Moderate or severe encephalopathy based on at least one risk of encephalopathy criterion (a) and one clinical signs of encephalopathy criterion (b):
- 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...
You likely can't join if
- Inability to enroll in the study and initiate the first dose of RLS-0071 within 10 hours of life.
- Known major congenital and/or chromosomal abnormality(ies).
- Severe growth restriction (birth weight ≤ 1800 g).
- Prenatal diagnosis of brain abnormality or hydrocephalus.
- Patient's head circumference is \< 30 cm.
- 10-minute APGAR score \< 2, if available.
See the full eligibility criteria
- ≥ 36 weeks gestation.
- 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...
- Moderate or severe encephalopathy based on at least one risk of encephalopathy criterion (a) and one clinical signs of encephalopathy criterion (b):
- 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]).
- 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).
- Be eligible to receive therapeutic hypothermia.
- Active whole-body cooling to be started prior to 6 hours of age (passive cooling is permitted prior to active whole body cooling).
- Product of a singleton pregnancy.
- Written informed consent obtained from parent or legal guardian.
- Inability to enroll in the study and initiate the first dose of RLS-0071 within 10 hours of life.
- Known major congenital and/or chromosomal abnormality(ies).
- Severe growth restriction (birth weight ≤ 1800 g).
- Prenatal diagnosis of brain abnormality or hydrocephalus.
- Patient's head circumference is \< 30 cm.
- 10-minute APGAR score \< 2, if available.
- Infants suspected of overwhelming sepsis or congenital infection based on the Investigator's clinical consideration at the time of enrollment.
- Persistent severe hypotension unresponsive to inotropic support (requiring \>2 inotropes, not inclusive of hydrocortisone).
- Persistent severe hypoxia in the setting of 100% fraction of inspired oxygen (FiO₂) and unresponsive to nitric oxide or requiring extracorporeal membrane oxygenation (ECMO).
- Severe disseminated intravascular coagulation with clinical bleeding.
- Neonatal encephalopathy believed to be due to a cause other than perinatal hypoxia (ie, other than HIE).
- Moribund infants for whom withdrawal of care being considered.
- Suspected or confirmed fetal alcohol syndrome or suspected substance withdraw seizures.
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Little Rock, Arkansas, United States
- Orange, California, United States
- San Diego, California, United States
- Gainesville, Florida, United States
- Miami, Florida, United States
- Orlando, Florida, United States
- Indianapolis, Indiana, United States
- Lexington, Kentucky, United States
- Boston, Massachusetts, United States
- St Louis, Missouri, United States
- Durham, North Carolina, United States
- Cleveland, Ohio, United States
- Fort Worth, Texas, United States
- Morgantown, West Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, up to 10 hours. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Little Rock, Arkansas, United States; Orange, California, United States; San Diego, California, United States; Gainesville, Florida, United States; Miami, Florida, United States; Orlando, Florida, United States and 8 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.