Hypoxic-Ischemic EncephalopathyPhase 2STARNCT05778188
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
A Phase 2 study testing RLS-0071 in people with Hypoxic-Ischemic Encephalopathy, run by ReAlta Life Sciences, Inc. at 15 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages Up to 10 hours
- Conditions the study is for
- Hypoxic-Ischemic Encephalopathy
- What is being tested?
- RLS-0071
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 15 sitesUnited States
- Study dates
- 27 Jul 2023to Dec 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 10 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- ≥ 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
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- 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.
Who cannot join
- 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.
Show all 14Show fewer
- 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).
Trial locations and contacts
15 sites in 1 country. Contact the study team or a site near you to ask about taking part.
15 sites in 1 country
United States15 sites, 14 recruiting
- Recruiting
Study Site 002
Boston, Massachusetts, 02115
- Recruiting
Study Site 021
Cleveland, Ohio, 44195
- Recruiting
Study Site 003
Durham, North Carolina, 27710
- Recruiting
Study Site 022
Fort Worth, Texas, 76104
- Recruiting
Study Site 001
Gainesville, Florida, 32608
- Recruiting
Study Site 014
Indianapolis, Indiana, 46202
- Withdrawn
Study Site 012
Lexington, Kentucky, 40536
- Recruiting
Study Site 016
Little Rock, Arkansas, 72202
- Recruiting
Study Site 018
Miami, Florida, 33143
- Recruiting
Study Site 005
Morgantown, West Virginia, 26506
- Recruiting
Study Site 013
Orange, California, 92868
- Recruiting
Study Site 010
Orlando, Florida, 32803
- Recruiting
Study Site 020
San Diego, California, 92037
- Recruiting
Study Site 019
San Diego, California, 92123
- Recruiting
Study Site 006
St Louis, Missouri, 63110
About this study
Official title: A Phase 2, Two-Stage, Randomized, Double-Blind, Placebo-Controlled, Multiple-Ascending Dose 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 With Long-Term Follow-Up
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.
Read the detailed description
This is a Phase 2, two-stage, multisite, randomized, double-blind, placebo-controlled, multiple-ascending dose study of RLS-0071 to assess the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy in newborns with moderate or severe HIE undergoing therapeutic hypothermia.
In Stage 1, participants will receive either ascending doses of RLS-0071 or a matched volume of placebo for 72 hours in addition to standard of care treatment, including therapeutic hypothermia. During and after the dosing period, participants will be monitored and assessed for safety evaluations through Day 14. After completion of Stage 1, participants will transition to Stage 2 of the study for long-term observation until participants reach 24 months of age.
The first cohort subsets, consisting of Cohort 1a (moderate HIE) and 1b (severe HIE), will receive a dose of 3 mg/kg RLS-0071 or a matched volume of placebo every 8 hours (q8h). A Data Safety Monitoring Board (DSMB) will review available clinical safety and PK data from Cohort 1 subsets with completed study intervention, and make a recommendation on whether to escalate the dose for moderate and severe HIE cohorts. The Sponsor will consider the DSMB recommendation to make their decision on dose escalation in addition to their own evaluation of all available safety and PK data. If the decision is made to escalate, Cohort 2 subsets (2a [moderate] and 2b [severe]) will be recruited to receive an escalated dose of RLS-0071 (10 mg/kg) or a matched volume of placebo. Following the completion of study intervention for each Cohort 2 subset (2a [moderate] or 2b [severe]), the DSMB will review available safety and PK data and make a recommendation whether to expand enrollment for Cohort 2+ (2a+ [moderate] or 2b+ [severe]) at 10 mg/kg RLS-0071 or a matched volume of placebo.
- Conditions
- Hypoxic-Ischemic Encephalopathy
- Being tested
- RLS-0071, Placebo
- Keywords
- Birth Asphyxia, Anoxic brain injury
- Medical subject headings
- Hypoxia-Ischemia, Brain, Asphyxia Neonatorum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RLS-0071Drug
RLS-0071 (unit strength 10 mg/mL) will be administered by infusion for a dose level of 3 or 10 mg/kg. Planned infusion duration is 10 minutes for all dose levels.
PlaceboDrug
Placebo control (commercial sterile saline) will be administered by infusion at a volume matched to RLS-0071 (3 or 10 mg/kg). Planned infusion duration is 10 minutes for all matched dose levels.
| Study group | Role | What they receive |
|---|---|---|
| RLS-0071 | Experimental | Doses of RLS-0071 to be administered every 8 hours (q8h), for a total of 10 doses over 72 hours. Receives: Drug: RLS-0071 |
| Placebo | Placebo comparator | Doses of sterile saline (sodium chloride, 0.9%) to be administered every 8 hours (q8h), for a total of 10 doses over 72 hours. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency and severity of adverse events (AEs) and serious adverse events (SAEs) by treatment group at Day 14
Number of participants with AEs and SAEs graded between Grade 1 (mild in severity) and Grade 5 (death related to AE).
Measured: Day 1 to Day 14
Frequency and severity of events of special interest and SAEs by treatment group at 24 months
Number of participants with events of special interest and SAEs graded between Grade 1 (mild in severity) and Grade 5 (death related to AE).
Events of special interest are: autoimmune disorder, persistent hypotension, persistent pulmonary hypertension, acute kidney injury, major venous thrombosis, severe intracranial hemorrhage, pulmonary hemorrhage, culture proven sepsis, necrotizing enterocolitis, severe thrombocytopenia, hepatic dysfunction, hyperbilirubinemia, coagulopathy, hypocalcemia, cerebral palsy, developmental or speech delay, learning disability, and visual or hearing impairment.
Measured: Day 1 to 24 months
Frequency of premature discontinuation by treatment group due to AEs at Day 14
Number of participants who prematurely discontinue from the study due to AEs
Measured: Day 1 to Day 14
Acute brain injury at Day 4, assessed through magnetic resonance imaging (MRI), using a standardized scoring system
Brain injury MRI score includes scoring extent of injury across 4 domains (Grey matter, White matter/cortex, Cerebellum, and Additional). A score of 0 indicates a normal brain MRI, whereas the maximum score of 57 indicates extensive bilateral injury.
Measured: Day 4
Acute brain injury at Day 12, assessed through magnetic resonance imaging (MRI), using a standardized scoring system
Brain injury MRI score includes scoring extent of injury across 4 domains (Grey matter, White matter/cortex, Cerebellum, and Additional). A score of 0 indicates a normal brain MRI, whereas the maximum score of 57 indicates extensive bilateral injury.
Measured: Day 12
Secondary outcomes (14)
Composite of mortality and neurodevelopmental impairment (NDI) at 24 months
Measured: Day 1 to 24 months
Mortality at 3, 6, 12, 18, and 24 months
Number of participants alive at each timepoint
Measured: Day 1 to 3, 6, 12, 18, and 24 months
Number of participants with clinically significant laboratory abnormalities, events of special interest, and SAEs at 3, 6, 12, and 18 months
Measured: Day 1 to 3, 6, 12, and 18 months
Neurocognitive developmental outcome assessed by Bayley-4 at 24 months of age
The Bayley Scales of Infant and Toddler Development (4th Edition) consists of 5 subdomains: the Cognitive, Language, Motor, Social-Emotional, and Adaptive Behavior scales. Cognitive, Language, and Motor domains include a total of 264 items, each ranked between 0-2 (where 0 is not present and 2 is mastery); the Social-Emotional and Adaptive Behavior domains are assessed through caregiver questionnaires.
Measured: 24 months
Neurodevelopmental growth impact: Diagnosis of cerebral palsy at 24 months of age
Number of participants diagnosed with cerebral palsy
Measured: 24 months
Neurodevelopmental growth impact: Grading of cerebral palsy by using the Gross Motor Function Classification System-Expanded and Revised (GMFCS-E&R) at 24 months of age
The GMFCS is a 5-level classification system for children and young people with cerebral palsy, where Level 1 indicates ability to walk without limitations and Level 5 indicates reliance on a manual wheelchair.
Measured: 24 months
Number of participants diagnosed with mild, moderate, or severe visual impairment and hearing impairment
Measured: Day 1 to 24 months
Number of days of supplemental nutritional support required
Measured: Day 1 to 24 months
Seizure occurrence
Discrete number of seizures recorded
Measured: Day 1 to Day 14
Total seizure burden (total number of minutes seizing as measured by continuous electroencephalogram [EEG]) during hospitalization
Measured: Day 1 to Day 14
Electrical activity abnormality scoring as measured by EEG
Measured: Day 1 to Day 14
Impact on infant and family wellness, assessed by the Mother-to-Infant Bonding Scale (MIBS)
The MIBS is a 9-item questionnaire, with total scores ranging from 0 to 27. A high score indicates weaker mother-to-infant bonding.
Measured: 3 and 12 months
Impact on infant and family wellness, assessed by the Parenting Stress Index, 4th Edition Short Form (PSI-4-SF)
The PSI-4 is a 36-item questionnaire focusing on three domains: Parental Distress, Parent-Child Dysfunctional Interaction, and Difficult Child, which combine to form a Total Stress scale. Scores are assessed following conversion into percentile ranks. Scores falling in the 90th or higher percentile indicate clinically significant parenting stress.
Measured: 3, 12, and 24 months
Quality of life assessment over the first 24 months of life
A quality of life questionnaire will be used to collect information regarding the care of the aging child over the first 24 months of life.
Measured: Day 4 to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2023
- Study start27 Jul 2023
- Primary completionDec 2026 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypoxic-Ischemic EncephalopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two-Stage, Randomized, Double-Blind, Placebo-Controlled, Multiple-Ascending Dose Study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ReAlta Life Sciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Premier Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05778188
- Sponsor's protocol ID
- RLS-0071-202
- Acronym
- STAR
- Status last verified
- Apr 2026
- First submitted
- 3 Mar 2023
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Two-Stage, Randomized, Double-Blind, Placebo-Controlled, Multiple-Ascending Dose 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 With Long-Term Follow-Up
- ClinicalTrials.gov ID
- NCT05778188
- Acronym / sponsor ID
- STAR / RLS-0071-202
- Conditions
- Hypoxic-Ischemic Encephalopathy
- Keywords
- Birth Asphyxia, Anoxic brain injury
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- ReAlta Life Sciences, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Premier Research
- Study start
- 27 Jul 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 21 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a Phase 2, two-stage, multisite, randomized, double-blind, placebo-controlled, multiple-ascending dose study of RLS-0071 to assess the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy in newborns with moderate or severe HIE undergoing therapeutic hypothermia.
In Stage 1, participants will receive either ascending doses of RLS-0071 or a matched volume of placebo for 72 hours in addition to standard of care treatment, including therapeutic hypothermia. During and after the dosing period, participants will be monitored and assessed for safety evaluations through Day 14. After completion of Stage 1, participants will transition to Stage 2 of the study for long-term observation until participants reach 24 months of age.
The first cohort subsets, consisting of Cohort 1a (moderate HIE) and 1b (severe HIE), will receive a dose of 3 mg/kg RLS-0071 or a matched volume of placebo every 8 hours (q8h). A Data Safety Monitoring Board (DSMB) will review available clinical safety and PK data from Cohort 1 subsets with completed study intervention, and make a recommendation on whether to escalate the dose for moderate and severe HIE cohorts. The Sponsor will consider the DSMB recommendation to make their decision on dose escalation in addition to their own evaluation of all available safety and PK data. If the decision is made to escalate, Cohort 2 subsets (2a [moderate] and 2b [severe]) will be recruited to receive an escalated dose of RLS-0071 (10 mg/kg) or a matched volume of placebo. Following the completion of study intervention for each Cohort 2 subset (2a [moderate] or 2b [severe]), the DSMB will review available safety and PK data and make a recommendation whether to expand enrollment for Cohort 2+ (2a+ [moderate] or 2b+ [severe]) at 10 mg/kg RLS-0071 or a matched volume of placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Two-Stage, Randomized, Double-Blind, Placebo-Controlled, Multiple-Ascending Dose Study
| Arm | Type | Receives |
|---|---|---|
| RLS-0071 | Experimental | Drug: RLS-0071Doses of RLS-0071 to be administered every 8 hours (q8h), for a total of 10 doses over 72 hours. |
| Placebo | Placebo comparator | Drug: PlaceboDoses of sterile saline (sodium chloride, 0.9%) to be administered every 8 hours (q8h), for a total of 10 doses over 72 hours. |
Who may qualify
- Ages
- Up to 10 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (15 listed)
- ≥ 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):
- OR
- Be eligible to receive therapeutic hypothermia.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RLS-0071RLS-0071 (unit strength 10 mg/mL) will be administered by infusion for a dose level of 3 or 10 mg/kg. Planned infusion duration is 10 minutes for all dose levels. | Drug | RLS-0071 |
| PlaceboPlacebo control (commercial sterile saline) will be administered by infusion at a volume matched to RLS-0071 (3 or 10 mg/kg). Planned infusion duration is 10 minutes for all matched dose levels. | Drug | Placebo |
Primary outcome
Frequency and severity of adverse events (AEs) and serious adverse events (SAEs) by treatment group at Day 14
Time frame: Day 1 to Day 14
Number of participants with AEs and SAEs graded between Grade 1 (mild in severity) and Grade 5 (death related to AE).
Frequency and severity of events of special interest and SAEs by treatment group at 24 months
Time frame: Day 1 to 24 months
Number of participants with events of special interest and SAEs graded between Grade 1 (mild in severity) and Grade 5 (death related to AE). Events of special interest are: autoimmune disorder, persistent hypotension, persistent pulmonary hypertension, acute kidney injury, major venous thrombosis, severe intracranial hemorrhage, pulmonary hemorrhage, culture proven sepsis, necrotizing enterocolitis, severe thrombocytopenia, hepatic dysfunction, hyperbilirubinemia, coagulopathy, hypocalcemia, cerebral palsy, developmental or speech delay, learning disability, and visual or hearing impairment.
Frequency of premature discontinuation by treatment group due to AEs at Day 14
Time frame: Day 1 to Day 14
Number of participants who prematurely discontinue from the study due to AEs
Acute brain injury at Day 4, assessed through magnetic resonance imaging (MRI), using a standardized scoring system
Time frame: Day 4
Brain injury MRI score includes scoring extent of injury across 4 domains (Grey matter, White matter/cortex, Cerebellum, and Additional). A score of 0 indicates a normal brain MRI, whereas the maximum score of 57 indicates extensive bilateral injury.
Acute brain injury at Day 12, assessed through magnetic resonance imaging (MRI), using a standardized scoring system
Time frame: Day 12
Brain injury MRI score includes scoring extent of injury across 4 domains (Grey matter, White matter/cortex, Cerebellum, and Additional). A score of 0 indicates a normal brain MRI, whereas the maximum score of 57 indicates extensive bilateral injury.
14 secondary outcomes
Composite of mortality and neurodevelopmental impairment (NDI) at 24 months
Time frame: Day 1 to 24 months
Mortality at 3, 6, 12, 18, and 24 months
Time frame: Day 1 to 3, 6, 12, 18, and 24 months
Number of participants with clinically significant laboratory abnormalities, events of special interest, and SAEs at 3, 6, 12, and 18 months
Time frame: Day 1 to 3, 6, 12, and 18 months
Neurocognitive developmental outcome assessed by Bayley-4 at 24 months of age
Time frame: 24 months
Neurodevelopmental growth impact: Diagnosis of cerebral palsy at 24 months of age
Time frame: 24 months
Neurodevelopmental growth impact: Grading of cerebral palsy by using the Gross Motor Function Classification System-Expanded and Revised (GMFCS-E&R) at 24 months of age
Time frame: 24 months
Number of participants diagnosed with mild, moderate, or severe visual impairment and hearing impairment
Time frame: Day 1 to 24 months
Number of days of supplemental nutritional support required
Time frame: Day 1 to 24 months
Seizure occurrence
Time frame: Day 1 to Day 14
Total seizure burden (total number of minutes seizing as measured by continuous electroencephalogram [EEG]) during hospitalization
Time frame: Day 1 to Day 14
Electrical activity abnormality scoring as measured by EEG
Time frame: Day 1 to Day 14
Impact on infant and family wellness, assessed by the Mother-to-Infant Bonding Scale (MIBS)
Time frame: 3 and 12 months
Impact on infant and family wellness, assessed by the Parenting Stress Index, 4th Edition Short Form (PSI-4-SF)
Time frame: 3, 12, and 24 months
Quality of life assessment over the first 24 months of life
Time frame: Day 4 to 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RLS-0071 in people with Hypoxic-Ischemic Encephalopathy, run by ReAlta Life Sciences, Inc. at 15 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lori Upham (757-901-0331, Lupham@realtals.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency and severity of adverse events (AEs) and serious adverse events (SAEs) by treatment group at Day 14 (time frame: Day 1 to Day 14). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.