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Showing 1–24 of 41 matching trials from the live ClinicalTrials.gov search.
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Filters: Condition: Hypothermia, Newborn 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Withdrawn Phase 1 Interventional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 Sep 25, 2026, 1:29 AM 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 25, 2026, 1:29 AM EDT
Completed Not applicable Interventional

Evaluation of a Novel Patient Warming System During MRI

NCT03150953
View directory record Official record
Conditions
Anesthesia; Hypothermia, Congenital Heart Disease
Interventions
MRI-safe bore covering
Device
Lead sponsor
Andrew Matisoff
Other
Eligibility
Up to 7 Years
Enrollment
60 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2018
U.S. locations
1
States / cities
Washington D.C., District of Columbia
Source: ClinicalTrials.gov public record
Updated Mar 27, 2019 · Synced Sep 25, 2026, 1:29 AM 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 Sep 25, 2026, 1:29 AM 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 25, 2026, 1:29 AM 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 25, 2026, 1:29 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 Sep 25, 2026, 1:29 AM EDT
Active, not recruiting Phase 1Phase 2 Interventional

Theophylline Prophylaxis During Hypothermia to Limit Neonatal Nephron Damage

NCT05853601
View directory record Official record
Conditions
Acute Kidney Injury, HIE
Interventions
Single Dose Theophylline, Repeat Dose Theophylline
Drug
Lead sponsor
Medical College of Wisconsin
Other
Eligibility
1 Hour to 18 Hours
Enrollment
30 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2027
U.S. locations
1
States / cities
Oklahoma City, Oklahoma
Source: ClinicalTrials.gov public record
Updated Jun 22, 2026 · Synced Sep 25, 2026, 1:29 AM 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 25, 2026, 1:29 AM 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 25, 2026, 1:29 AM EDT
Withdrawn Not applicable Interventional

Hypothermia During ECMO to Decrease Brain Injury

NCT01675388
View directory record Official record
Conditions
Neonatal Respiratory Failure
Interventions
Hypothermia
Other
Lead sponsor
Sood, Beena G., MD, MS
Individual
Eligibility
1 Day to 28 Days
Healthy volunteers
Healthy volunteers not accepted
Timeline
2012 – 2017
U.S. locations
1
States / cities
Detroit, Michigan
Source: ClinicalTrials.gov public record
Updated Nov 17, 2014 · Synced Sep 25, 2026, 1:29 AM 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 Sep 25, 2026, 1:29 AM 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 Sep 25, 2026, 1:29 AM 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 25, 2026, 1:29 AM 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 25, 2026, 1:29 AM 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 25, 2026, 1:29 AM 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 25, 2026, 1:29 AM EDT
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 Sep 25, 2026, 1:29 AM 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 25, 2026, 1:29 AM EDT
Completed Not applicable Interventional Accepts healthy volunteers

OMT to Improve Feeding After Hypothermia

NCT03380013
View directory record Official record
Conditions
Neonatal Encephalopathy, Feeding; Difficult, Newborn
Interventions
Osteopathic Manipulative Treatment (OMT)
Procedure
Lead sponsor
MaineHealth
Other
Eligibility
37 Weeks and older
Enrollment
12 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2017 – 2019
U.S. locations
1
States / cities
Portland, Maine
Source: ClinicalTrials.gov public record
Updated May 30, 2019 · Synced Sep 25, 2026, 1:29 AM 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 25, 2026, 1:29 AM EDT
Completed No phase listed Observational Results available

CoolCap Followup Study-Coordination of Participating Centers

NCT00581581
View directory record Official record
Conditions
Neonatal Encephalopathy
Interventions
Not listed
Lead sponsor
University of Rochester
Other
Eligibility
6 Years to 8 Years
Enrollment
62 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2007 – 2009
U.S. locations
1
States / cities
Rochester, New York
Source: ClinicalTrials.gov public record
Updated Mar 7, 2013 · Synced Sep 25, 2026, 1:29 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 Sep 25, 2026, 1:29 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 Sep 25, 2026, 1:29 AM EDT