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ClinicalTrials.gov public records Last synced Jun 10, 2026, 8:29 AM EDT

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Showing 25–48 of 24 matching trials from the live ClinicalTrials.gov search.
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Filters: Condition: Neonatal Hypoxic-Ischemic Encephalopathy (HIE) Clear all
Recruiting No phase listed Observational

Intensive Multimodal Neurorehabilitation Targeting Neuroplasticity in Pediatric Neurodevelopmental and Chromosomal Disorders

NCT07493096
View directory record Official record
Conditions
Neurodevelopmental Disorders, Neurodevelopmental Disorders (NDD), Neurodevelopmental Disorders and Developmental Abnormalities, Developmental Delay (Disorder), Cerebral Palsy (CP), Cerebral Palsy Hemiparetic Cerebral Palsy Spasticity Gait Disorders, Neurologic Postural Balance Impairment, Cerebral Palsy Infantile, Cerebral Palsy Spastic Hemiplegic, Cerebral Palsy, Dyskinetic, Autism Spectrum Disorder, Autism Spectrum Disorder (ASD, Hypoxic Ischemic Encephalopathy, Hypoxic Ischemic Encephalopathy (HIE), Traumatic Brain Injury (TBI), Sensory Processing Disorder, Chromosomal Abnormalities, Genetic Disorders, Down Syndrome (Trisomy 21), Fragile X Syndrome (FXS), RETT Syndrome With Proven MECP2 Mutation, Williams Syndrome, 22q11.2 Deletion Syndrome, Sensorimotor Integration
Interventions
Not listed
Lead sponsor
Healing Hope International
Other
Eligibility
4 Years to 12 Years
Enrollment
100 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2036
U.S. locations
1
States / cities
The Woodlands, Texas
Source: ClinicalTrials.gov public record
Updated Mar 24, 2026 · Synced Jun 10, 2026, 8:29 AM EDT
Completed Phase 1Phase 2 Interventional Results available

Darbe Administration in Newborns Undergoing Cooling for Encephalopathy

NCT01471015
View directory record Official record
Conditions
Hypoxic Ischemic Encephalopathy
Interventions
Darbepoetin alfa, Placebo
Drug
Lead sponsor
University of Utah
Other
Eligibility
Up to 24 Hours
Enrollment
30 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2012 – 2014
U.S. locations
7
States / cities
Albuquerque, New Mexico • Nashville, Tennessee • Ogden, Utah + 3 more
Source: ClinicalTrials.gov public record
Updated Jul 22, 2024 · Synced Jun 10, 2026, 8:29 AM EDT
Completed Not applicable Interventional

CoolCap Trial, Treatment of Perinatal Hypoxic-Ischemic Encephalopathy

NCT00383305
View directory record Official record
Conditions
Neonatal Hypoxic-Ischemic Encephalopathy (HIE)
Interventions
Cool-Cap
Device
Lead sponsor
Olympic Medical
Industry
Eligibility
1 Hour to 6 Hours
Enrollment
235 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
1999 – 2003
U.S. locations
19
States / cities
Little Rock, Arkansas • Oakland, California • San Diego, California + 15 more
Source: ClinicalTrials.gov public record
Updated Oct 2, 2006 · Synced Jun 10, 2026, 8:29 AM EDT
Withdrawn Phase 1 Interventional

PK and Safety of Caffeine in Neonates With Hypoxic Ischemic Encephalopathy Receiving Therapeutic Hypothermia

NCT05295784
View directory record Official record
Conditions
Acute Kidney Injury, Hypoxic-Ischemic Encephalopathy, Caffeine
Interventions
Caffeine citrate
Drug
Lead sponsor
University of Arkansas
Other
Eligibility
0 Hours to 24 Hours
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024
U.S. locations
2
States / cities
Little Rock, Arkansas
Source: ClinicalTrials.gov public record
Updated May 9, 2024 · Synced Jun 10, 2026, 8:29 AM EDT
Withdrawn Phase 2 Interventional

Autologous Cord Blood and Human Placental Derived Stem Cells in Neonates With Severe Hypoxic-Ischemic Encephalopathy

NCT02434965
View directory record Official record
Conditions
Severe Hypoxic-ischemic Encephalopathy
Interventions
HPDSC, Cord blood
Drug
Lead sponsor
New York Medical College
Other
Eligibility
1 Minute to 6 Hours
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2022
U.S. locations
1
States / cities
Valhalla, New York
Source: ClinicalTrials.gov public record
Updated Feb 22, 2021 · Synced Jun 10, 2026, 8:29 AM EDT
Not listed Not applicable Interventional

TIME Study: Therapeutic Hypothermia for Infants With Mild Encephalopathy

NCT04176471
View directory record Official record
Conditions
Hypoxic-Ischemic Encephalopathy Mild, Neonatal Encephalopathy
Interventions
Therapeutic Hypothermia, Normothermia
Other
Lead sponsor
Stanford University
Other
Eligibility
Up to 6 Hours
Enrollment
68 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2025
U.S. locations
5
States / cities
Loma Linda, California • Oakland, California • Orange, California + 2 more
Source: ClinicalTrials.gov public record
Updated Mar 17, 2020 · Synced Jun 10, 2026, 8:29 AM EDT
Completed Phase 2 Interventional Results available

A Multi-site Study of Autologous Cord Blood Cells for Hypoxic Ischemic Encephalopathy

NCT02612155
View directory record Official record
Conditions
Moderate or Severe Hypoxic-ischemic Encephalopathy in Newborns
Interventions
Infusion of autologous cord blood, Placebo
Biological
Lead sponsor
Michael Cotten
Other
Eligibility
0 Hours to 6 Hours
Enrollment
35 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2019
U.S. locations
1
States / cities
Durham, North Carolina
Source: ClinicalTrials.gov public record
Updated May 15, 2024 · Synced Jun 10, 2026, 8:29 AM EDT
Recruiting Phase 2 Interventional

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

NCT05778188
View directory record Official record
Conditions
Hypoxic-Ischemic Encephalopathy
Interventions
RLS-0071, Placebo
Drug
Lead sponsor
ReAlta Life Sciences, Inc.
Industry
Eligibility
Up to 10 Hours
Enrollment
70 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2028
U.S. locations
15
States / cities
Little Rock, Arkansas • Orange, California • San Diego, California + 11 more
Source: ClinicalTrials.gov public record
Updated Apr 12, 2026 · Synced Jun 10, 2026, 8:29 AM EDT
Not yet recruiting No phase listed Observational Accepts healthy volunteers

Neonatal Neurological Observation With Video AI

NCT07628829
View directory record Official record
Conditions
Neonatal Encephalopathy, Hypoxic-Ischemic Encephalopathy, Sedation, Sleep
Interventions
Continuous bedside video monitoring with AI anatomic landmark tracking for neurologic monitoring
Device
Lead sponsor
Artemis AI Labs
Industry
Eligibility
Not listed
Enrollment
200 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2026 – 2029
U.S. locations
2
States / cities
New York, New York
Source: ClinicalTrials.gov public record
Updated Jun 7, 2026 · Synced Jun 10, 2026, 8:29 AM EDT
Completed No phase listed Observational Results available

Prospective Research in Infants With Mild Encephalopathy

NCT01747863
View directory record Official record
Conditions
Hypoxic-Ischemic Encephalopathy, Brain Injury, Neonatal Seizure
Interventions
Neurologic examination
Other
Lead sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Other
Eligibility
Up to 6 Hours
Enrollment
63 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2012 – 2017
U.S. locations
4
States / cities
Detroit, Michigan • Columbus, Ohio • Providence, Rhode Island + 1 more
Source: ClinicalTrials.gov public record
Updated Jan 27, 2025 · Synced Jun 10, 2026, 8:29 AM EDT
Recruiting No phase listed Observational

Perinatal Brain Injury: Potential of Innovative NIRS to Optimize Hypothermia

NCT02793999
View directory record Official record
Conditions
Hypoxic Ischemic Brain Injury, Neonatal Encephalopathy
Interventions
Near-Infrared Spectroscopy (NIRS)
Device
Lead sponsor
Boston Children's Hospital
Other
Eligibility
Up to 2 Years
Enrollment
125 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2028
U.S. locations
3
States / cities
Boston, Massachusetts
Source: ClinicalTrials.gov public record
Updated Dec 9, 2025 · Synced Jun 10, 2026, 8:29 AM EDT
Recruiting No phase listed Observational Accepts healthy volunteers

Biomarkers Study in Infants With Prior Neonatal Brain Injury

NCT07413900
View directory record Official record
Conditions
HIE - Hypoxic - Ischemic Encephalopathy, Perinatal Anoxic-ischemic Brain Injury, Premature Birth, Healthy Participants
Interventions
Not listed
Lead sponsor
University of Wisconsin, Madison
Other
Eligibility
3 Months to 24 Months
Enrollment
100 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2023 – 2030
U.S. locations
1
States / cities
Madison, Wisconsin
Source: ClinicalTrials.gov public record
Updated Feb 16, 2026 · Synced Jun 10, 2026, 8:29 AM EDT
Enrolling by invitation No phase listed Observational

Florida Neonatal Neurologic Network

NCT02260271
View directory record Official record
Conditions
Hypoxic-Ischemic Encephalopathy
Interventions
Database Entry/Biospecimen Collection
Other
Lead sponsor
University of Florida
Other
Eligibility
1 Day to 3 Weeks
Enrollment
1,000 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2011 – 2045
U.S. locations
1
States / cities
Gainesville, Florida
Source: ClinicalTrials.gov public record
Updated Feb 10, 2026 · Synced Jun 10, 2026, 8:29 AM EDT
Completed No phase listed Observational

Pharmacokinetics of Ampicillin in Neonates With Moderate to Severe Hypoxic-Ischemic Encephalopathy

NCT03129620
View directory record Official record
Conditions
Hypothermia
Interventions
Not listed
Lead sponsor
Drexel University
Other
Eligibility
6 Hours to 24 Hours
Enrollment
14 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2016
U.S. locations
1
States / cities
Philadelphia, Pennsylvania
Source: ClinicalTrials.gov public record
Updated Apr 25, 2017 · Synced Jun 10, 2026, 8:29 AM EDT
Completed Phase 1 Interventional Results available

Pilot Study of Head Cooling in Preterm Infants With Hypoxic Ischemic Encephalopathy

NCT00620711
View directory record Official record
Conditions
Hypoxic Ischemic Encephalopathy
Interventions
Olympic Cool Cap
Device
Lead sponsor
Vanderbilt University
Other
Eligibility
30 Minutes to 6 Hours
Enrollment
4 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2008 – 2013
U.S. locations
1
States / cities
Nashville, Tennessee
Source: ClinicalTrials.gov public record
Updated Jan 28, 2019 · Synced Jun 10, 2026, 8:29 AM EDT
Recruiting No phase listed Observational Accepts healthy volunteers

Healthy Little Eyes

NCT05971446
View directory record Official record
Conditions
Hypoxic-Ischemic Encephalopathy, Neonatal Encephalopathy, Encephalopathy
Interventions
Visual Evoked Potential (VEP), Electroretinogram (ERG)
Device
Lead sponsor
University of Wisconsin, Madison
Other
Eligibility
Up to 36 Months
Enrollment
125 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2020 – 2029
U.S. locations
1
States / cities
Madison, Wisconsin
Source: ClinicalTrials.gov public record
Updated May 13, 2026 · Synced Jun 10, 2026, 8:29 AM EDT
Completed No phase listed Observational

Umbilical Cord Blood Proteomic Analysis and Neonatal Brain Injury

NCT00375908
View directory record Official record
Conditions
Hypoxia-Ischemia, Brain, Periventricular Leukomalacia
Interventions
Not listed
Lead sponsor
Johns Hopkins University
Other
Eligibility
Not listed
Enrollment
4 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2005 – 2008
U.S. locations
1
States / cities
Baltimore, Maryland
Source: ClinicalTrials.gov public record
Updated Aug 31, 2015 · Synced Jun 10, 2026, 8:29 AM EDT
Recruiting Phase 1 Interventional

Dose Optimization of Caffeine for HIE

NCT06448780
View directory record Official record
Conditions
Hypoxic-Ischemic Encephalopathy
Interventions
Caffeine citrate 20 mg/kg, Caffeine citrate 30 mg/kg
Drug
Lead sponsor
University of North Carolina, Chapel Hill
Other
Eligibility
Up to 24 Hours
Enrollment
16 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2028
U.S. locations
2
States / cities
Chapel Hill, North Carolina • Wilmington, North Carolina
Source: ClinicalTrials.gov public record
Updated Apr 6, 2026 · Synced Jun 10, 2026, 8:29 AM EDT
Completed Not applicable Interventional Results available

Therapeutic Intervention Supporting Development From NICU to 6 Months for Infants Post Hypoxic-Ischemic Encephalopathy

NCT05130528
View directory record Official record
Conditions
Cerebral Palsy, Hypoxic-Ischemic Encephalopathy
Interventions
Sensorimotor Intervention
Behavioral
Lead sponsor
University of Southern California
Other
Eligibility
Up to 6 Months
Enrollment
11 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2024
U.S. locations
2
States / cities
Los Angeles, California
Source: ClinicalTrials.gov public record
Updated May 18, 2026 · Synced Jun 10, 2026, 8:29 AM EDT
Withdrawn Phase 1 Interventional

Melatonin Treatment for Newborn Infants With Moderate to Severe Hypoxic Ischemic Encephalopathy

NCT01904786
View directory record Official record
Conditions
Newborn Hypoxic Ischemic Encephalopathy
Interventions
Melatonin, placebo
Drug
Lead sponsor
St. Louis University
Other
Eligibility
1 Hour to 8 Hours
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014 – 2018
U.S. locations
1
States / cities
St Louis, Missouri
Source: ClinicalTrials.gov public record
Updated Jul 2, 2015 · Synced Jun 10, 2026, 8:29 AM EDT
Active, not recruiting No phase listed Observational

Transcutaneous Carbon Dioxide Monitoring in Neonates Receiving Therapeutic Hypothermia for Neonatal Encephalopathy

NCT04603547
View directory record Official record
Conditions
Neonatal Encephalopathy
Interventions
Transcutaneous Carbon Dioxide Monitoring
Device
Lead sponsor
Brigham and Women's Hospital
Other
Eligibility
0 Days to 3 Days
Enrollment
53 participants
Timeline
2019 – 2027
U.S. locations
1
States / cities
Boston, Massachusetts
Source: ClinicalTrials.gov public record
Updated Feb 24, 2026 · Synced Jun 10, 2026, 8:29 AM EDT
Completed Phase 1 Interventional Results available

Caffeine for Hypoxic-Ischemic Encephalopathy

NCT03913221
View directory record Official record
Conditions
Hypoxic-Ischemic Encephalopathy
Interventions
Caffeine Citrate 5 mg/kg, Caffeine Citrate 10 mg/kg
Drug
Lead sponsor
University of North Carolina, Chapel Hill
Other
Eligibility
Up to 24 Hours
Enrollment
17 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2024
U.S. locations
1
States / cities
Chapel Hill, North Carolina
Source: ClinicalTrials.gov public record
Updated Mar 26, 2025 · Synced Jun 10, 2026, 8:29 AM EDT
Completed Phase 2 Interventional Results available

Dexmedetomidine Use in Infants Undergoing Cooling Due to Neonatal Encephalopathy (DICE Trial)

NCT04772222
View directory record Official record
Conditions
Hypoxic-Ischemic Encephalopathy, Pain
Interventions
Dexmedetomidine Hydrochloride, Morphine Sulfate
Drug
Lead sponsor
University of Utah
Other
Eligibility
Up to 24 Hours
Enrollment
50 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2025
U.S. locations
5
States / cities
Murray, Utah • Ogden, Utah • Provo, Utah + 1 more
Source: ClinicalTrials.gov public record
Updated Mar 5, 2026 · Synced Jun 10, 2026, 8:29 AM EDT
Terminated No phase listed Observational Accepts healthy volunteers

Quantitative Assessment of Sucking for Early Diagnosis of Brain Injury in Infants at High Risk

NCT03246243
View directory record Official record
Conditions
Hypoxic-Ischemic Encephalopathy, Hypoglycemia, Neonatal Abstinence Syndrome
Interventions
nfant feeding solution
Device
Lead sponsor
Boston Children's Hospital
Other
Eligibility
Up to 6 Months
Enrollment
16 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2017 – 2021
U.S. locations
1
States / cities
Boston, Massachusetts
Source: ClinicalTrials.gov public record
Updated May 20, 2021 · Synced Jun 10, 2026, 8:29 AM EDT