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Showing 1–24 of 41 matching trials from the live ClinicalTrials.gov search.
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Filters: Condition: Neonatal Hypothermia Clear all
Completed Not applicable Interventional Accepts healthy volunteers

Hypothermia and the Effect of Ambient Temperature 2

NCT03008577
View directory record Official record
Conditions
Hypothermia, Neonatal Outcome, Cesarean Section
Interventions
Change in ambient operating room temperature
Other
Lead sponsor
University of Texas Southwestern Medical Center
Other
Eligibility
Female only
Enrollment
5,221 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2016 – 2018
U.S. locations
1
States / cities
Dallas, Texas
Source: ClinicalTrials.gov public record
Updated Oct 14, 2018 · Synced Jul 23, 2026, 9:31 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Withdrawn Phase 1 Interventional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 Jul 23, 2026, 9:31 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 23, 2026, 9:31 PM 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 Jul 23, 2026, 9:31 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 23, 2026, 9:31 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 Jul 23, 2026, 9:31 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 5, 2026 · Synced Jul 23, 2026, 9:31 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 Jul 23, 2026, 9:31 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 23, 2026, 9:31 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 23, 2026, 9:31 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 Jul 23, 2026, 9:31 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 Jul 23, 2026, 9:31 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 Jul 23, 2026, 9:31 PM EDT
Completed Not applicable Interventional Accepts healthy volunteers

Plastic Hat Trial to Prevent Hypothermia in Preterm Newborns in the Delivery Room

NCT00904228
View directory record Official record
Conditions
Hypothermia
Interventions
placement of plastic cap during delivery room stabilization, placement of routine cap during delivery room stabilization
Other
Lead sponsor
University of Texas Southwestern Medical Center
Other
Eligibility
Up to 1 Hour
Enrollment
260 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2008 – 2010
U.S. locations
1
States / cities
Dallas, Texas
Source: ClinicalTrials.gov public record
Updated Apr 24, 2019 · Synced Jul 23, 2026, 9:31 PM EDT
Completed Not applicable Interventional Accepts healthy volunteers

Hypothermia and the Effect of Ambient Temperature

NCT02436382
View directory record Official record
Conditions
Hypothermia
Interventions
change in temperature
Other
Lead sponsor
University of Texas Southwestern Medical Center
Other
Eligibility
Female only
Enrollment
846 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2015
U.S. locations
1
States / cities
Dallas, Texas
Source: ClinicalTrials.gov public record
Updated May 10, 2016 · Synced Jul 23, 2026, 9:31 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 23, 2026, 9:31 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 23, 2026, 9:31 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 Jul 23, 2026, 9:31 PM EDT
Completed Not applicable Interventional

Enteral Feeding and Splanchnic NIRS Values in Infants With Neonatal Encephalopathy (NE)

NCT05471336
View directory record Official record
Conditions
Neonatal Encephalopathy
Interventions
Enteral Feeding
Procedure
Lead sponsor
NYU Langone Health
Other
Eligibility
0 Days to 2 Days
Enrollment
40 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2024
U.S. locations
1
States / cities
New York, New York
Source: ClinicalTrials.gov public record
Updated May 1, 2024 · Synced Jul 23, 2026, 9:31 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 Jul 23, 2026, 9:31 PM EDT
Completed Phase 2 Interventional

Pilot Study For Hypothermia Treatment In Hyperammonemic Encephalopathy In Neonates And Very Young Infants

NCT01624311
View directory record Official record
Conditions
Urea Cycle Disorders, Organic Acidemias
Interventions
Therapeutic Hypothermia, Standard of Care Therapy
Other
Lead sponsor
Uta Lichter-Konecki
Other
Eligibility
1 Day to 30 Days
Enrollment
5 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2007 – 2015
U.S. locations
3
States / cities
Washington D.C., District of Columbia • New York, New York • Milwaukee, Wisconsin
Source: ClinicalTrials.gov public record
Updated May 31, 2015 · Synced Jul 23, 2026, 9:31 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 Jul 23, 2026, 9:31 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 Jul 23, 2026, 9:31 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 16, 2021 · Synced Jul 23, 2026, 9:31 PM EDT