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Showing 1–24 of 56 matching trials from the live ClinicalTrials.gov search.
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Filters: Condition: Neonatal Hypoxic-Ischemic Encephalopathy (HIE) Clear all
Withdrawn Phase 1 Interventional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 Jul 21, 2026, 3:59 PM EDT
Terminated Phase 1Phase 2 Interventional Results available

Topiramate in Neonates Receiving Whole Body Cooling for Hypoxic Ischemic Encephalopathy

NCT01765218
View directory record Official record
Conditions
Hypoxic Ischemic Encephalopathy
Interventions
Topiramate, Placebo
Drug
Lead sponsor
Kristin R Hoffman
Other
Eligibility
Up to 6 Hours
Enrollment
34 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2022
U.S. locations
1
States / cities
Sacramento, California
Source: ClinicalTrials.gov public record
Updated Jun 10, 2024 · Synced Jul 21, 2026, 3:59 PM 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 Jul 21, 2026, 3:59 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 20, 2021 · Synced Jul 21, 2026, 3:59 PM EDT
Active, not recruiting No phase listed Observational

Neonatal Seizure Registry, GEnetics of Post-Neonatal Epilepsy

NCT05361070
View directory record Official record
Conditions
Neonatal Seizure, Hypoxic-Ischemic Encephalopathy, Stroke, Intracranial Hemorrhage, Epilepsy, Gene Abnormality
Interventions
Not listed
Lead sponsor
University of California, San Francisco
Other
Eligibility
Not listed
Enrollment
300 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2027
U.S. locations
8
States / cities
San Francisco, California • Washington D.C., District of Columbia • Boston, Massachusetts + 4 more
Source: ClinicalTrials.gov public record
Updated Feb 4, 2026 · Synced Jul 21, 2026, 3:59 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 11, 2017 · Synced Jul 21, 2026, 3:59 PM EDT
Terminated Not applicable Interventional Results available

Optimizing (Longer, Deeper) Cooling for Neonatal Hypoxic-Ischemic Encephalopathy(HIE)

NCT01192776
View directory record Official record
Conditions
Infant, Newborn, Hypoxia, Brain, Hypoxia-Ischemia, Brain, Encephalopathy, Hypoxic-Ischemic, Hypoxic-Ischemic Encephalopathy, Ischemic-Hypoxic Encephalopathy
Interventions
Whole-body Cooling
Procedure
Lead sponsor
NICHD Neonatal Research Network
Network
Eligibility
Up to 6 Hours
Enrollment
364 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2010 – 2016
U.S. locations
19
States / cities
Birmingham, Alabama • Los Angeles, California • Palo Alto, California + 15 more
Source: ClinicalTrials.gov public record
Updated Jun 23, 2026 · Synced Jul 21, 2026, 3:59 PM EDT
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 17, 2020 · Synced Jul 21, 2026, 3:59 PM EDT
Completed Phase 1 Interventional

Neonatal Erythropoietin in Asphyxiated Term Newborns

NCT00719407
View directory record Official record
Conditions
Hypoxic-ischemic Encephalopathy
Interventions
erythropoietin
Drug
Lead sponsor
University of California, San Francisco
Other
Eligibility
Up to 24 Hours
Enrollment
24 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2010 – 2012
U.S. locations
1
States / cities
San Francisco, California
Source: ClinicalTrials.gov public record
Updated Nov 8, 2012 · Synced Jul 21, 2026, 3:59 PM EDT
Completed No phase listed Observational

Bedside Optical Retinal Assessment of Hypoxic Ischemic Encephalopathy in Infants

NCT03640494
View directory record Official record
Conditions
Hypoxic-Ischemic Encephalopathy
Interventions
Optical Coherence Tomography
Device
Lead sponsor
Duke University
Other
Eligibility
Up to 20 Days
Enrollment
57 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2021
U.S. locations
2
States / cities
Durham, North Carolina • Salt Lake City, Utah
Source: ClinicalTrials.gov public record
Updated Apr 7, 2021 · Synced Jul 21, 2026, 3:59 PM 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 Jul 21, 2026, 3:59 PM 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 Jul 21, 2026, 3:59 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 4, 2026 · Synced Jul 21, 2026, 3:59 PM EDT
Recruiting Not applicable Interventional

Spinal Stimulation and Mobility Devices

NCT05520359
View directory record Official record
Conditions
Cerebral Palsy, Stroke, Premature Birth, Hypoxic-Ischemic Encephalopathy, Periventricular Leukomalacia
Interventions
Mobility Device, Spinal Stimulation
Device
Lead sponsor
University of Washington
Other
Eligibility
4 Years to 70 Years
Enrollment
20 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2026
U.S. locations
1
States / cities
Seattle, Washington
Source: ClinicalTrials.gov public record
Updated Aug 12, 2025 · Synced Jul 21, 2026, 3:59 PM EDT
Recruiting No phase listed Observational

Baby Brain Recovery Study

NCT05013736
View directory record Official record
Conditions
Perinatal Stroke
Interventions
Magnetic Resonance Imaging, Behavioral Assessments, Non invasive Transcranial Magnetic Stimulation
Device · Behavioral
Lead sponsor
University of Wisconsin, Madison
Other
Eligibility
0 Years to 24 Months
Enrollment
65 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2026
U.S. locations
1
States / cities
Madison, Wisconsin
Source: ClinicalTrials.gov public record
Updated Jan 7, 2026 · Synced Jul 21, 2026, 3:59 PM 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 Jul 21, 2026, 3:59 PM EDT
Recruiting No phase listed Observational

Genetics of Neonatal Encephalopathy and Related Disorders

NCT07165938
View directory record Official record
Conditions
Neonatal Encephalopathy, Hypoxic Ischaemic Encephalopathy (HIE)
Interventions
Not listed
Lead sponsor
Boston Children's Hospital
Other
Eligibility
Not listed
Enrollment
300 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2035
U.S. locations
1
States / cities
Boston, Massachusetts
Source: ClinicalTrials.gov public record
Updated Mar 10, 2026 · Synced Jul 21, 2026, 3:59 PM EDT
Completed No phase listed Observational

Hypothermia's Effect on Hepatitis B Vaccination

NCT05787899
View directory record Official record
Conditions
Hypoxic-Ischemic Encephalopathy, Hepatitis B Vaccination, Hypothermia, Newborn
Interventions
Hypothermia Protocol
Other
Lead sponsor
Medical University of South Carolina
Other
Eligibility
0 Hours to 72 Hours
Enrollment
9 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2024
U.S. locations
1
States / cities
Charleston, South Carolina
Source: ClinicalTrials.gov public record
Updated Oct 27, 2024 · Synced Jul 21, 2026, 3:59 PM 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 Jul 21, 2026, 3:59 PM EDT
Completed Phase 1 Interventional

Cord Blood for Neonatal Hypoxic-ischemic Encephalopathy

NCT00593242
View directory record Official record
Conditions
Neonatal Hypoxic Ischemic Encephalopathy
Interventions
infusion of autologous cord blood, Neurodevelopmental outcomes
Biological · Other
Lead sponsor
Michael Cotten
Other
Eligibility
Up to 14 Days
Enrollment
52 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2008 – 2017
U.S. locations
1
States / cities
Durham, North Carolina
Source: ClinicalTrials.gov public record
Updated May 15, 2024 · Synced Jul 21, 2026, 3:59 PM 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 Jul 21, 2026, 3:59 PM EDT
Recruiting Not applicable Interventional

Effects of a Physical Therapy Intervention on Motor Delay in Infants Admitted to a Neonatal Intensive Care Unit

NCT05568264
View directory record Official record
Conditions
Motor Delay, Premature Birth, Intraventricular Hemorrhage, Hypoxic-Ischemic Encephalopathy, Bronchopulmonary Dysplasia
Interventions
Physical Therapy intervention
Other
Lead sponsor
Shirley Ryan AbilityLab
Other
Eligibility
33 Weeks to 48 Weeks
Enrollment
222 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2026
U.S. locations
3
States / cities
Chicago, Illinois
Source: ClinicalTrials.gov public record
Updated May 20, 2025 · Synced Jul 21, 2026, 3:59 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 28, 2026 · Synced Jul 21, 2026, 3:59 PM 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 Jul 21, 2026, 3:59 PM EDT