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Showing 1–24 of 41 matching trials from the live ClinicalTrials.gov search.
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Filters: Condition: Hypothermia Neonatal Clear all
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 Sep 8, 2026, 4:35 PM EDT
Recruiting No phase listed Observational

Cerebral/ Cortical Visual Impairment: Screening, Identification and Outcome Prediction in Neonates

NCT07275021
View directory record Official record
Conditions
Preterm Less Than 32wks With IVH, WMI/PVL, Late Preterm or Term (37-42wks) With Neonatal Encephalopathy Treated With Hypothermia for HIE
Interventions
Prospective Clinical and Neurodevelopmental Data Collection
Other
Lead sponsor
Brigham and Women's Hospital
Other
Eligibility
31 Weeks to 42 Weeks
Enrollment
60 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2028
U.S. locations
1
States / cities
Boston, Massachusetts
Source: ClinicalTrials.gov public record
Updated Dec 9, 2025 · Synced Sep 8, 2026, 4:35 PM EDT
Completed Not applicable Interventional Results available

Neonatal Warming to Prevent Hypothermia

NCT04827394
View directory record Official record
Conditions
Hypothermia
Interventions
Neonatal warming mattress, Sterile polyethylene wrap
Device
Lead sponsor
University of Oklahoma
Other
Eligibility
Up to 55 Years · Female only
Enrollment
52 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2023
U.S. locations
1
States / cities
Oklahoma City, Oklahoma
Source: ClinicalTrials.gov public record
Updated Apr 30, 2024 · Synced Sep 8, 2026, 4:35 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 Sep 8, 2026, 4:35 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 9, 2025 · Synced Sep 8, 2026, 4:35 PM EDT
Completed Not applicable Interventional Results available

Telemedicine to Improve Use of Therapeutic Hypothermia in Rural Settings

NCT03706417
View directory record Official record
Conditions
Neonatal Encephalopathy
Interventions
Telemedicine consult
Diagnostic Test
Lead sponsor
MaineHealth
Other
Eligibility
Up to 6 Hours
Enrollment
115 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2023
U.S. locations
1
States / cities
Portland, Maine
Source: ClinicalTrials.gov public record
Updated Sep 11, 2025 · Synced Sep 8, 2026, 4:35 PM EDT
Completed No phase listed Observational Accepts healthy volunteers

Testing A Visual Thermometer in Newborns and Young Infants

NCT05609292
View directory record Official record
Conditions
Hyperthermia, Hypothermia
Interventions
observational
Device
Lead sponsor
University of Minnesota
Other
Eligibility
0 Months to 6 Months
Enrollment
120 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2022 – 2023
U.S. locations
1
States / cities
Minneapolis, Minnesota
Source: ClinicalTrials.gov public record
Updated Nov 27, 2023 · Synced Sep 8, 2026, 4:35 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 Sep 8, 2026, 4:35 PM 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 Sep 8, 2026, 4:35 PM EDT
Terminated Phase 1 Interventional

Cold Heart Study: A Randomized Pilot Trial of Surfactant Therapy

NCT04181255
View directory record Official record
Conditions
Congenital Heart Disease, Hypoplastic Left Heart Syndrome
Interventions
Curosurf, Sham
Drug
Lead sponsor
University of Michigan
Other
Eligibility
1 Day to 12 Weeks
Enrollment
2 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020
U.S. locations
1
States / cities
Ann Arbor, Michigan
Source: ClinicalTrials.gov public record
Updated Sep 12, 2023 · Synced Sep 8, 2026, 4:35 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 Sep 8, 2026, 4:35 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 Sep 8, 2026, 4:35 PM EDT
Not listed Not applicable Interventional

Early Weaning From Incubator To Crib

NCT06230172
View directory record Official record
Conditions
Hypothermia, Newborn, Body Temperature Changes, Newborn Thermal Injury
Interventions
Weaning incubator (heat) at an lower postnatal weight
Radiation
Lead sponsor
Augusta University
Other
Eligibility
Not listed
Enrollment
50 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2024
U.S. locations
1
States / cities
Augusta, Georgia
Source: ClinicalTrials.gov public record
Updated Feb 6, 2024 · Synced Sep 8, 2026, 4:35 PM EDT
Completed Phase 1 Interventional

Study of hCT-MSC in Newborn Infants With Moderate or Severe HIE

NCT03635450
View directory record Official record
Conditions
Moderate to Severe Hypoxic-ischemic Encephalopathy
Interventions
Infusion of hCT-MSC
Biological
Lead sponsor
Joanne Kurtzberg, MD
Other
Eligibility
0 Hours to 48 Hours
Enrollment
6 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2020
U.S. locations
1
States / cities
Durham, North Carolina
Source: ClinicalTrials.gov public record
Updated Apr 11, 2024 · Synced Sep 8, 2026, 4:35 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 Sep 8, 2026, 4:35 PM EDT
Not listed Not applicable Interventional

Optimising the Duration of Cooling in Mild Encephalopathy

NCT03409770
View directory record Official record
Conditions
Neonatal Encephalopathy, Hypothermia Neonatal, Magnetic Resonance Spectroscopy
Interventions
Therapeutic hypothermia
Other
Lead sponsor
Thayyil, Sudhin
Individual
Eligibility
Up to 6 Hours
Enrollment
140 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2024
U.S. locations
1
States / cities
Michigan Center, Michigan
Source: ClinicalTrials.gov public record
Updated Aug 3, 2023 · Synced Sep 8, 2026, 4:35 PM EDT
Completed Not applicable Interventional Results available

Late Hypothermia for Hypoxic-Ischemic Encephalopathy

NCT00614744
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
Procedure
Lead sponsor
NICHD Neonatal Research Network
Network
Eligibility
6 Hours to 24 Hours
Enrollment
168 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2008 – 2016
U.S. locations
22
States / cities
Birmingham, Alabama • Los Angeles, California • Palo Alto, California + 18 more
Source: ClinicalTrials.gov public record
Updated Mar 8, 2021 · Synced Sep 8, 2026, 4:35 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 Sep 8, 2026, 4:35 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 Sep 8, 2026, 4:35 PM EDT
Terminated Not applicable Interventional Results available

Perioperative Warming Measures in Cesarean Delivery

NCT05015582
View directory record Official record
Conditions
Hypothermia; Anesthesia, Hypothermia, Newborn, Hypothermia, Sequela
Interventions
Pre op upper body forced air warming (32˚C), Pre op lower body forced air warming (32˚C), Pre op fluids (45˚C), Intra op upper body forced air warming (32˚C), Intra op fluids at room temperature, Intra op upper body forced air warming at (32˚C), Intra op upper body forced air warming at (42˚C), Intra op lower body forced air warming at (32˚C), Intra op lower body forced air warming at (42˚C), Intra op fluid (42˚C)
Device
Lead sponsor
The University of Texas Health Science Center, Houston
Other
Eligibility
18 Years and older · Female only
Enrollment
16 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021
U.S. locations
1
States / cities
Houston, Texas
Source: ClinicalTrials.gov public record
Updated May 13, 2026 · Synced Sep 8, 2026, 4:35 PM EDT
Not listed Not applicable Interventional

Evaluation of a Novel Neonatal Temperature Monitor

NCT03866122
View directory record Official record
Conditions
Neonatal Hypothermia
Interventions
NTM Monitoring
Device
Lead sponsor
William Marsh Rice University
Other
Eligibility
Up to 28 Days
Enrollment
150 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2022
U.S. locations
1
States / cities
Houston, Texas
Source: ClinicalTrials.gov public record
Updated Sep 9, 2021 · Synced Sep 8, 2026, 4:35 PM EDT
Completed Not applicable Interventional Accepts healthy volunteers Results available

Warming Mattress Versus Polyethylene Wrapping to Prevent Hypothermia in Preterm Newborns.

NCT00603837
View directory record Official record
Conditions
Hypothermia
Interventions
NeoWrap, InfaTherm
Device
Lead sponsor
University of Oklahoma
Other
Eligibility
24 Weeks to 28 Weeks
Enrollment
36 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2007 – 2008
U.S. locations
1
States / cities
Oklahoma City, Oklahoma
Source: ClinicalTrials.gov public record
Updated Oct 15, 2009 · Synced Sep 8, 2026, 4:35 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 21, 2019 · Synced Sep 8, 2026, 4:35 PM EDT
Completed Phase 1Phase 2 Interventional Results available

Neonatal Erythropoietin And Therapeutic Hypothermia Outcomes in Newborn Brain Injury (NEATO)

NCT01913340
View directory record Official record
Conditions
Hypoxic-ischemic Encephalopathy, Neonatal Encephalopathy, Birth Asphyxia
Interventions
Erythropoietin, Normal saline
Drug
Lead sponsor
University of California, San Francisco
Other
Eligibility
30 Minutes to 24 Hours
Enrollment
50 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2016
U.S. locations
7
States / cities
Little Rock, Arkansas • Palo Alto, California • San Francisco, California + 4 more
Source: ClinicalTrials.gov public record
Updated Jul 12, 2020 · Synced Sep 8, 2026, 4:35 PM EDT