Orlando, FLNCT05778188Now EnrollingIRB Ready

Birth Asphyxia Clinical Trial in Orlando, FL

Access cutting-edge birth asphyxia treatment through this phase 2 clinical trial at a research site in Orlando. Study-provided care at no cost to qualified participants.

Sponsored by ReAlta Life Sciences, Inc.

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Expert Care in Orlando

Access birth asphyxia specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related birth asphyxia treatment provided free

Apply for This Orlando Location

Check if you qualify for this birth asphyxia clinical trial in Orlando, FL

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Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Local to Orlando

    Convenient for FL residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Orlando site if eligible
  4. 4Begin participation

About This Birth Asphyxia Study in Orlando

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 e

Sponsor: ReAlta Life Sciences, Inc.

Who Can Participate

Inclusion 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 delivery or an acute change in the fetal status with a clinical presentation consistent with an acute sentinel event with no clearly defined etiology.
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.

Exclusion Criteria

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 \[eg, Grade 3 or 4\] intracranial hemorrhage).

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Orlando?

Yes, this clinical trial (NCT05778188) has an active research site in Orlando, FL that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Birth Asphyxia Treatment Options in Orlando, FL

If you're searching for birth asphyxia treatment options in Orlando, FL, this clinical trial (NCT05778188) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Orlando research site is actively enrolling participants for this phase 2 clinical trial. You'll receive care from experienced birth asphyxia specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all birth asphyxia clinical trials near you to find additional studies recruiting in your area.

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