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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
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 Jul 21, 2026, 9:26 AM 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Withdrawn Phase 1 Interventional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 21, 2026, 9:26 AM 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 21, 2026, 9:26 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 Jul 21, 2026, 9:26 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 Jul 21, 2026, 9:26 AM 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, 9:26 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 Jul 21, 2026, 9:26 AM 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, 9:26 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 Jul 21, 2026, 9:26 AM 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, 9:26 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 Jul 21, 2026, 9:26 AM EDT
Completed Phase 2Phase 3 Interventional

Cylexin for Reduction of Reperfusion Injury in Infant Heart Surgery

NCT00226369
View directory record Official record
Conditions
Congenital Heart Defects
Interventions
CY-1503
Drug
Lead sponsor
Boston Children's Hospital
Other
Eligibility
Up to 45 Days
Enrollment
242 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
1997 – 2001
U.S. locations
1
States / cities
Boston, Massachusetts
Source: ClinicalTrials.gov public record
Updated Feb 11, 2010 · Synced Jul 21, 2026, 9:26 AM 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, 9:26 AM 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 Jul 21, 2026, 9:26 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 Jul 21, 2026, 9:26 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 Jul 21, 2026, 9:26 AM 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 21, 2026, 9:26 AM 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, 9:26 AM 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, 9:26 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 Jul 21, 2026, 9:26 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 Jul 21, 2026, 9:26 AM 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 21, 2026, 9:26 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 Jul 21, 2026, 9:26 AM 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 21, 2026, 9:26 AM EDT