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ClinicalTrials.gov public records Last synced Oct 10, 2026, 11:38 PM EDT

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Showing 1–24 of 59 matching trials from the live ClinicalTrials.gov search.
Filters: Condition: Neonatal Encephalopathy (Neonatal Hypoxic-ischemic Encephalopathy) Clear all
Completed No phase listed Observational

Developmental Outcomes

NCT02264808
View directory record Official record
Conditions
Hypoxic-Ischemic Encephalopathy
Interventions
Developmental Outcomes
Other
Lead sponsor
University of Florida
Other
Eligibility
18 Months to 20 Months
Enrollment
21 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014 – 2018
U.S. locations
1
States / cities
Gainesville, Florida
Source: ClinicalTrials.gov public record
Updated Jan 18, 2020 · Synced Oct 10, 2026, 11:38 PM EDT
Recruiting Phase 2 Interventional

A Dose Escalation Study of Levetiracetam in the Treatment of Neonatal Seizures

NCT05610085
View directory record Official record
Conditions
Neonatal Seizure, Neonatal Encephalopathy, Hypoxic-Ischemic Encephalopathy, Seizure Newborn
Interventions
Levetiracetam Injection, Phenobarbital Sodium Injection
Drug
Lead sponsor
University of California, San Diego
Other
Eligibility
Up to 1 Month
Enrollment
133 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2027
U.S. locations
2
States / cities
San Diego, California • Minneapolis, Minnesota
Source: ClinicalTrials.gov public record
Updated Jun 15, 2026 · Synced Oct 10, 2026, 11:38 PM EDT
Recruiting Phase 2 Interventional

Treatment of Neonatal Encephalopathy With Oral Sildenafil Suspension to Repair Brain Injury Secondary to Birth Asphyxia

NCT06098833
View directory record Official record
Conditions
Neonatal Encephalopathy
Interventions
Sildenafil, Ora-Blend
Drug
Lead sponsor
Pia Wintermark
Other
Eligibility
0 Minutes to 48 Hours
Enrollment
60 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2031
U.S. locations
1
States / cities
Denver, Colorado
Source: ClinicalTrials.gov public record
Updated Sep 17, 2026 · Synced Oct 10, 2026, 11:38 PM 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 17, 2026 · Synced Oct 10, 2026, 11:38 PM EDT
Active, not 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 Aug 14, 2026 · Synced Oct 10, 2026, 11:38 PM 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 6, 2026 · Synced Oct 10, 2026, 11:38 PM 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 21, 2021 · Synced Oct 10, 2026, 11:38 PM EDT
Recruiting Not applicable Interventional

The HIEnome Study: Genome Sequencing for Perinatal HIE

NCT06762795
View directory record Official record
Conditions
Hypoxic Ischemic Encephalopathy of Newborn, Hypoxic Ischemic Encephalopathy, Hypoxic Ischemic Encephalopathy (HIE)
Interventions
Genome sequencing
Genetic
Lead sponsor
Baylor College of Medicine
Other
Eligibility
0 Days to 1 Year
Enrollment
25 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2027
U.S. locations
1
States / cities
Houston, Texas
Source: ClinicalTrials.gov public record
Updated Oct 1, 2026 · Synced Oct 10, 2026, 11:38 PM EDT
Completed Not applicable Interventional Results available

Preemie Hypothermia for Neonatal Encephalopathy

NCT01793129
View directory record Official record
Conditions
Infant, Newborn, Hypoxia, Brain, Hypoxia-Ischemia, Brain, Encephalopathy, Hypoxic-Ischemic, Hypoxic-Ischemic Encephalopathy, Ischemic-Hypoxic Encephalopathy
Interventions
Hypothermia, Normothermic Control
Device · Procedure
Lead sponsor
NICHD Neonatal Research Network
Network
Eligibility
33 Weeks to 35 Weeks
Enrollment
168 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2022
U.S. locations
18
States / cities
Birmingham, Alabama • Palo Alto, California • Atlanta, Georgia + 14 more
Source: ClinicalTrials.gov public record
Updated Nov 4, 2024 · Synced Oct 10, 2026, 11:38 PM EDT
Withdrawn Not applicable Interventional Accepts healthy volunteers

Maternal Hyperoxygenation for Intrapartum Fetal Heart Rate Tracing Abnormalities

NCT03996317
View directory record Official record
Conditions
Perinatal Death, Respiratory Distress Syndrome, Newborn, Hypoxic-Ischemic Encephalopathy, Neonatal Seizure, Meconium Aspiration Syndrome, Intracranial Hemorrhages, Neonatal Hypotension
Interventions
Room air
Other
Lead sponsor
Loma Linda University
Other
Eligibility
18 Years to 55 Years · Female only
Healthy volunteers
Accepts healthy volunteers
Timeline
2021 – 2022
U.S. locations
1
States / cities
Loma Linda, California
Source: ClinicalTrials.gov public record
Updated Aug 17, 2021 · Synced Oct 10, 2026, 11:38 PM EDT
Not yet recruiting No phase listed Observational

Newborn Brain Assessment - CergenX Wave

NCT07857070
View directory record Official record
Conditions
Neonatal Encephalopathy, Neonatal Encephalopathy (Neonatal Hypoxic-ischemic Encephalopathy), Neonatal Encephalopathy, Unspecified
Interventions
CergenX Wave
Device
Lead sponsor
CergenX Limited
Industry
Eligibility
36 Weeks and older
Enrollment
165 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2027
U.S. locations
1
States / cities
Dallas, Texas
Source: ClinicalTrials.gov public record
Updated Oct 5, 2026 · Synced Oct 10, 2026, 11:38 PM EDT
Completed Phase 3 Interventional Results available

CEUS Evaluation of Hypoxic Ischemic Injury

NCT03549520
View directory record Official record
Conditions
Hypoxic-Ischemic Encephalopathy, Brain Ischemia Hypoxia
Interventions
Sulfur hexafluoride lipid-type A microspheres
Drug
Lead sponsor
Children's Hospital of Philadelphia
Other
Eligibility
1 Minute to 18 Months
Enrollment
1 participant
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2024
U.S. locations
1
States / cities
Philadelphia, Pennsylvania
Source: ClinicalTrials.gov public record
Updated May 14, 2025 · Synced Oct 10, 2026, 11:38 PM EDT
Completed Phase 2 Interventional Results available

A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of TAK-935 (OV935) as an Adjunctive Therapy in Pediatric Participants With Developmental and/or Epileptic Encephalopathies

NCT03650452
View directory record Official record
Conditions
Epilepsy, Dravet Syndrome, Lennox-Gastaut Syndrome
Interventions
TAK-935, Placebo
Drug
Lead sponsor
Takeda
Industry
Eligibility
2 Years to 17 Years
Enrollment
141 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2020
U.S. locations
15
States / cities
Phoenix, Arizona • Los Angeles, California • Aurora, Colorado + 12 more
Source: ClinicalTrials.gov public record
Updated Sep 14, 2026 · Synced Oct 10, 2026, 11:38 PM 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 16, 2024 · Synced Oct 10, 2026, 11:38 PM 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 10, 2025 · Synced Oct 10, 2026, 11:38 PM EDT
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 25, 2026 · Synced Oct 10, 2026, 11:38 PM EDT
Completed Phase 2 Interventional Results available

Mild Encephalopathy in the Newborn Treated With Darbepoetin

NCT03071861
View directory record Official record
Conditions
Neonatal Encephalopathy, Hypoxic-Ischemic Encephalopathy Mild
Interventions
Darbepoetin Alfa, Normal Saline
Drug
Lead sponsor
University of New Mexico
Other
Eligibility
1 Hour to 24 Hours
Enrollment
28 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2022
U.S. locations
1
States / cities
Salt Lake City, Utah
Source: ClinicalTrials.gov public record
Updated Dec 21, 2023 · Synced Oct 10, 2026, 11:38 PM EDT
Completed No phase listed Observational

Neonatal Seizure Registry - Developmental Functional EValuation

NCT04337697
View directory record Official record
Conditions
Neonatal Seizure, Hypoxic-Ischemic Encephalopathy, Stroke, Intracranial Hemorrhages, Epilepsy, Cerebral Palsy, Intellectual Disability
Interventions
Not listed
Lead sponsor
University of California, San Francisco
Other
Eligibility
2 Years to 8 Years
Enrollment
188 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2025
U.S. locations
9
States / cities
San Francisco, California • Stanford, California • Washington D.C., District of Columbia + 5 more
Source: ClinicalTrials.gov public record
Updated Feb 5, 2026 · Synced Oct 10, 2026, 11:38 PM EDT
Recruiting No phase listed Observational

Cool Prime Comparative Effectiveness Study for Mild HIE

NCT04621279
View directory record Official record
Conditions
Mild Hypoxic Ischemic Encephalopathy of Newborn
Interventions
Normothermia, Whole body therapeutic hypothermia
Procedure
Lead sponsor
University of Texas Southwestern Medical Center
Other
Eligibility
36 Weeks and older
Enrollment
460 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2029
U.S. locations
1
States / cities
Dallas, Texas
Source: ClinicalTrials.gov public record
Updated Sep 25, 2026 · Synced Oct 10, 2026, 11:38 PM EDT
Completed Not applicable Interventional

The Impact of Holding on Stress and Bonding in Mother-Infant Pairs During Therapeutic Hypothermia

NCT03837717
View directory record Official record
Conditions
Hypoxic-Ischemic Encephalopathy, Neonatal Encephalopathy
Interventions
Holding, Saliva collection, No Holding
Behavioral · Other
Lead sponsor
MaineHealth
Other
Eligibility
24 Hours to 2 Days
Enrollment
34 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2021
U.S. locations
1
States / cities
Portland, Maine
Source: ClinicalTrials.gov public record
Updated Dec 17, 2021 · Synced Oct 10, 2026, 11:38 PM EDT
Recruiting Early Phase 1 Interventional

Melatonin as a Neuroprotective Therapy in Neonates With HIE Undergoing Hypothermia

NCT02621944
View directory record Official record
Conditions
Hypoxic Ischemic Encephalopathy
Interventions
Melatonin, Magnetic Resonance Imaging, Pharmacokinetics, Neurological Outcome Assessment
Drug · Other · Behavioral
Lead sponsor
University of Florida
Other
Eligibility
Up to 6 Hours
Enrollment
70 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2027
U.S. locations
2
States / cities
Gainesville, Florida • Orlando, Florida
Source: ClinicalTrials.gov public record
Updated Jun 29, 2026 · Synced Oct 10, 2026, 11:38 PM 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 18, 2020 · Synced Oct 10, 2026, 11:38 PM EDT
Completed Early Phase 1 Interventional

Dexmedetomidine Pharmacokinetics in Neonates During Therapeutic Hypothermia

NCT02529202
View directory record Official record
Conditions
Hypoxic-ischemic Encephalopathy
Interventions
Dexmedetomidine
Drug
Lead sponsor
Seattle Children's Hospital
Other
Eligibility
1 Hour to 1 Day
Enrollment
7 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2017
U.S. locations
1
States / cities
Seattle, Washington
Source: ClinicalTrials.gov public record
Updated Jan 12, 2017 · Synced Oct 10, 2026, 11:38 PM EDT
Completed Phase 3 Interventional

Whole-Body Cooling for Birth Asphyxia in Term Infants

NCT00005772
View directory record Official record
Conditions
Infant, Newborn, Hypoxia-Ischemia, Brain
Interventions
Induced hypothermia, Control
Device
Lead sponsor
NICHD Neonatal Research Network
Network
Eligibility
Up to 6 Hours
Enrollment
208 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
1999 – 2010
U.S. locations
16
States / cities
Birmingham, Alabama • Palo Alto, California • New Haven, Connecticut + 13 more
Source: ClinicalTrials.gov public record
Updated Mar 22, 2019 · Synced Oct 10, 2026, 11:38 PM EDT