Clinical trials: Targeted Temperature Management
Newborn Asphyxia
Is Feeding During Therapeutic Hypothermia Safe and Can Improve Outcomes in Infants With Hypoxic-ischaemic Encephalopathy
Therapeutic hypothermia (TH) is the standard of care for newborns with moderate to severe hypoxic-ischaemic encephalopathy (HIE) born at 35 weeks or more of gestation.
- Trial name
- NCT06394453
- Testing
- enteral feeding with mother milk or human donor breast milk
- Where
- Poland
- Volunteers
- 104 people
- Sponsor
- Nutricia Foundation
Hypoxic-Ischemic Encephalopathy
Metabolic Monitoring During Therapeutic Hypothermia (Cooling) for Hypoxic Ischaemic Encephalopathy
This study aims to determine if CGM can be safely used in these babies, and to use this alongside innovative methods to measure alternative fuels to optimise care of these vulnerable babies.
- Trial name
- MeCool (NCT06932354)
- Testing
- CGM
- Where
- United Kingdom
- Volunteers
- 16 people
- Sponsor
- Kathryn Beardsall
Hypoxic-Ischemic Encephalopathy, Pain
The Effect of Maternal Scent and Knitted Octopus Application on Pain in Infants Diagnosed With Neonatal Asphyxia and Receiving Therapeutic Hypothermia Treatment
This study was designed to determine the effects of maternal scent and knitted octopus application on pain in infants born with asphyxia beyond 36 weeks' gestation and receiving Therapeutic Hypothermia (TH) treatment in the…
- Trial name
- Pain in HIE (NCT07526233)
- Testing
- scent
- Where
- Turkey (Türkiye)
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Alev Sivasli
Hypoxic-Ischemic Encephalopathy
The Effects of Minimal Enteral Nutrition on Mesenteric Blood Flow and Oxygenation in Neonates With HIE
The goal of this clinical trial is to evaluate the effects of minimal enteral nutrition (MEN) on mesenteric blood flow and oxygenation with Doppler USG and Near Infrared Spectroscopy (NIRS) during therapeutic hypo¬thermia (TH) in…
- Trial name
- NCT06344286
- Testing
- Minimal enteral nutrition, Distilled water
- Where
- Turkey (Türkiye)
- Volunteers
- 60 people
- Sponsor
- Istanbul Training and Research Hospital
Narcotic Consumption, Pain
Motorized Continuous Cold Therapy Versus Standard Post-op Icing Protocol for Two Foot and Ankle Procedures
This study will compares differences in pain level, narcotic consumption, wound healing, patient satisfaction in patients randomized to the Iceman® cold pack therapy system (djOrtho, Inc) versus those who use ice.
- Conditions
- Narcotic Consumption, Pain, Wound Healing, Patient Satisfaction
- Trial name
- NCT00950183
- Testing
- Iceman® Cold Therapy unit (djOrtho), Ice
- Where
- United States
- Volunteers
- 36 people
- Sponsor
- OrthoCarolina Research Institute, Inc.
Temperature Monitoring
Non-invasive Temperature Monitoring in Pediatric Intensive Care Patients Requiring Targeted Temperature Management: Evaluation of Temple Touch Pro
The purpose of this study is to evaluate the Temple Touch Pro (TTP) in Pediatric Intensive Care Unity (PICU) patients requiring targeted temperature control.
- Trial name
- NCT07507396
- Testing
- Temple Touch Pro
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Medical College of Wisconsin
Encephalopathy, Hypoxic-Ischemic, Infant, Newborn, Diseases
Effect of Allopurinol for Hypoxic-ischemic Brain Injury on Neurocognitive Outcome
Neonatal hypoxic-ischemic encephalopathy (HIE) is a major cause of death or long-term disability in infants born at term in the western world, affecting about 1-4 per 1.000 life births and consequently about 5-20.000 infants per…
- Trial name
- ALBINO (NCT03162653)
- Testing
- Allopurinol, Mannitol
- Where
- 12 sites in Austria, Belgium and 10 more
- Volunteers
- 760 people
- Sponsor
- University Hospital Tuebingen
Anoxic-Ischemic Encephalopathy
Becoming Children With Perinatal Anoxo-Ischemic Encephalopathy Without Indication of Therapeutic Hypothermia
There are 3 levels of severity of anoxo-ischemic encephalopathy (EAI): mild, moderate and severe. Therapeutic hypothermia is beneficial in children with moderate EAI.
- Trial name
- SARNATUN (NCT03744481)
- Testing
- Questionaire
- Where
- France
- Volunteers
- 68 people
- Sponsor
- Hospices Civils de Lyon
Hypoxic Ischemic Encephalopathy
Reno-protective Effect of Brain Cooling in Newborn With Hypoxia
This study aims to determine the effect of therapeutic hypothermia on reducing AKI in term and late-preterm infants with hypoxic ischemic encephalopathy as estimated by measurment of serum(s) neutrophil gelatinase-associated…
- Trial name
- NCT02683915
- Testing
- Therapeutic hypothermia
- Where
- Egypt
- Volunteers
- 30 people
- Sponsor
- Mansoura University Children Hospital
Severe Hypoxic Ischemic Encephalopathy, Moderate Hypoxic Ischemic Encephalopathy
Efficacy Study of Hypothermia Plus Magnesium Sulphate(MgSO4) in the Management of Term and Near Term Babies With Hypoxic Ischemic Encephalopathy
The purpose of this study is to assess whether the addition of a drug such as Magnesium sulphate while providing therapeutic hypothermia (or cooling) to babies who are asphyxiated at birth provides additional benefit to the…
- Trial name
- MagCool (NCT01646619)
- Testing
- Magnesium Sulphate
- Where
- 7 sites in Egypt, Malaysia and 4 more
- Volunteers
- 300 people
- Sponsor
- Sajjad Rahman
Hypothermia Neonatal, Haemodynamic Instability
Evaluation of Haemodynamic in Neonates Treated With Hypothermia"
Perinatal hypoxia in the form of hypoxic-ischaemic encephalopathy (HIE) is a frequent cause of cerebral impairment in neonates. HIE occurs in 3 to 5 of 1000 neonates in developed countries and is significantly higher in…
- Conditions
- Hypothermia Neonatal, Haemodynamic Instability, Perinatal Asphyxia
- Trial name
- NCT05574855
- Where
- 4 sites in Poland
- Volunteers
- 113 people
- Sponsor
- Princess Anna Mazowiecka Hospital, Warsaw, Poland
Hypoxic Ischemic Encephalopathy (HIE)
Severity of Hypoxic Ischemic Encephalopathy and Neurological Pupil Index in Neonates
The goal of this observational study is to learn if the reactivity of a newborn's eye to light (measured as an index, using a new device -pupillometer) reflect the health of their brain recovering from disruption of blood/oxygen…
- Trial name
- SHINE (NCT07024771)
- Testing
- Automated Pupillometer
- Where
- Canada
- Volunteers
- 25 people
- Sponsor
- University of Calgary
Perinatal Anoxic-ischemic Brain Injury
Hypothermia Enhanced by Magnesium Sulphate
New 2010 neonatal resuscitation guidelines state that offering therapeutic hypothermia (TH) should be a standard of care in managing neonates with perinatal hypoxic - ischemic insult and present with signs of moderate and/or…
- Trial name
- Hemen (NCT02499393)
- Testing
- Magnesium Sulfate
- Where
- Poland
- Volunteers
- 75 people
- Sponsor
- Polish Mother Memorial Hospital Research Institute
Hypoxic Ischemic Encephalopathy
Whole Body Cooling Using Phase Changing Material
A prospective randomized control trial to examine safety and effectiveness of whole body cooling to a rectal temperature of 33.5 C using phase changing material in neonatal encephalopathy.
- Trial name
- NCT01138176
- Testing
- Cooling
- Where
- India
- Volunteers
- 35 people
- Sponsor
- Robertson, Nicola, M.D.
Neonatal Encephalopathy
Magnetic Resonance Biomarkers in Neonatal Encephalopathy
N-acetylaspartate (NAA) is a surrogate neuronal marker and its proton magnetic resonance spectroscopy (1H MRS) signal decreases with increasing neuronal mortality associated with cerebral hypoxia-ischaemia.
- Trial name
- MARBLE (NCT01309711)
- Where
- United Kingdom
- Volunteers
- 180 people, healthy volunteers welcome
- Sponsor
- Imperial College London
Hypoxic-ischemic Encephalopathy (HIE)
The PROTECT-HIE Pilot Trial
Some babies experience a lack of oxygen and blood flow around the time of birth. This can lead to a serious condition called hypoxic-ischemic encephalopathy (HIE), which can injure the brain and other organs, including the heart.
- Trial name
- PROTECT-HIE (NCT07406477)
- Testing
- Dobutamine, TnECHO
- Where
- 2 sites in Canada
- Volunteers
- 40 people
- Sponsor
- University of Alberta
Out-of-Hospital Cardiac Arrest
Induced Hypothermia in Cardiac Arrest Patients Rescued by Extracorporeal Cardiopulmonary Resuscitation.
Background： Cardiopulmonary resuscitation (CPR) with closed-chest cardiac massage has been shown that survival to discharge rate is poor.
- Trial name
- NCT00965016
- Testing
- hypothermia
- Where
- Taiwan
- Volunteers
- 45 people
- Sponsor
- Min-Sheng General Hospital
Appendicitis
Cold Therapy for Pediatric Appendectomy
This is a randomized control trial to evaluate the efficacy of an FDA approved cold therapy device vs. usual care among children undergoing appendectomy at a large children's hospital.
- Trial name
- NCT04986397
- Testing
- Cold Therapy, Standard of Care
- Where
- United States
- Volunteers
- 52 people
- Sponsor
- Boston Children's Hospital
Safety Issues
Paracetamol Hypothermia Children
Transient Acetaminophen Induced Hypothermia in Pediatrics Population Undergoing General Anesthesia
- Trial name
- NCT04608669
- Testing
- Paracetamol
- Where
- Lebanon
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Saint George Hospital
Encephalopathy, Hypoxic-Ischemic
Safety of Clonidine in Infants With Hypoxic Ischemic Encephalopathy During Therapeutic Hypothermia
This research is being done to find out the safety of the investigational study drug, Clonidine Hydrochloride ( CLON). , in infants who are undergoing whole body cooling for the treatment of hypoxic ischemic encephalopathy (HIE).
- Trial name
- HIE (NCT01862250)
- Testing
- Clonidine (Duraclon®)
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- Johns Hopkins University