Clinical trials: Targeted Temperature Management, open to volunteers
Hypoxic-Ischemic Encephalopathy
A Study of a Blood Marker in Newborns With Brain Injury Caused by Lack of Oxygen at Birth
Perinatal asphyxia is a significant health problem with an incidence of 1 to 8 per 1,000 live births and can lead to serious morbidity and mortality during the neonatal period.
- Trial name
- NCT07292220
- Where
- Turkey (Türkiye)
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Mustafa Gürkan
Hypoxic Ischemic Brain Injury, Neonatal Encephalopathy
Dexmedetomidine Versus Morphine During Cooling Therapy in Neonates
About ~3/ 1000 live-born newborns may suffer from brain injury due to a transient drop in oxygen supply to the brain during the birth process.
- Conditions
- Hypoxic Ischemic Brain Injury, Neonatal Encephalopathy, Perinatal Anoxic-ischemic Brain Injury
- Trial name
- COOL-SED (NCT06985290)
- Testing
- Dexmedetomidine Infusion, Morphine Infusion
- Where
- Canada
- Volunteers
- 50 people
- Sponsor
- Ipsita Goswami
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
Out-Of-Hospital Cardiac Arrest, Cardiopulmonary Resuscitation
PRE-hospital Cooling to improvE carDiac arrEst Neurological outComEs (PRECEDENCE)
The PRE-hospital Cooling to improvE carDiac arrEst Neurological outComEs (PRECEDENCE) study is a pilot feasibility trial evaluating the implementation of pre-hospital targeted temperature management (TTM) using a wearable surface…
- Conditions
- Out-Of-Hospital Cardiac Arrest, Cardiopulmonary Resuscitation, Death, Sudden, Cardiac, Therapeutic Hypothermia
- Trial name
- PRECEDENCE (NCT07421882)
- Testing
- CarbonCool® Cooling Vest
- Where
- Singapore
- Volunteers
- 50 people
- Sponsor
- Singapore General Hospital
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
Neonatal Encephalopathy, Therapeutic Hypothermia
The Long-term Consequences of Neonatal Encephalopathy in the Hypothermia Era
The goal of this study is to characterize the ability and related brain profiles of children with Neonatal encephalopathy (NE) - Therapeutic hypothermia (TH) at 9 years old. The main questions it aims to answer are: 1.
- Conditions
- Neonatal Encephalopathy, Therapeutic Hypothermia, Brain Injuries, Child Development
- Trial name
- NCT05756296
- Testing
- Therapeutic hypothermia
- Where
- 2 sites in Canada
- Volunteers
- 198 people
- Sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
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
Neonatal Encephalopathy, Newborn Asphyxia
Cooling in Mild Encephalopathy
The goal of this randomised control trial is to establish the safety and efficacy of whole-body hypothermia for babies with mild hypoxic ischaemic encephalopathy, inform national and international guidelines, and establish…
- Trial name
- COMET (NCT05889507)
- Testing
- Whole body hypothermia, Targeted normothermia, Supportive neonatal intensive care
- Where
- 39 sites in Italy, United Kingdom
- Volunteers
- 426 people
- Sponsor
- Imperial College London
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
Encephalopathy, Hypoxic Ischemic
Neurodevelopmental Outcome in Newborn With Hypoxic-ischemic Encephalopathy Treated With Therapeutic Hypothermia
The goal of this observational study is to identify early signs of poor neurodevelopmental outcome by performing specific neurological, neurophysiological and neuroimaging assessments in newborns with hypoxic-ischemic…
- Trial name
- NCT05767476
- Testing
- Clinical and instrumental neurological assessment
- Where
- 2 sites in Italy
- Volunteers
- 70 people
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Hypoxic-Ischemic Encephalopathy, Perinatal Asphyxia
EEG-Based Decision-Support Algorithm for Hypoxic-Ischemic Encephalopathy in Term Newborns
This retrospective, multicenter, observational study evaluates how well a decision-support algorithm can tell apart mild forms of hypoxic-ischemic encephalopathy (HIE) from moderate or severe forms in full-term newborns born…
- Conditions
- Hypoxic-Ischemic Encephalopathy, Perinatal Asphyxia, Neonatal Brain Injury
- Trial name
- COOLDECIDE (NCT07764315)
- Volunteers
- 310 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Therapeutic Hypothermia, Neonatal Hypoxic-Ischemic Encephalopathy
Continuous Monitoring of Body Temperature in Neonates During Therapeutic Hypothermia
This prospective observational pilot study aims to evaluate the feasibility, accuracy, and safety of the SteadyTemp® wireless adhesive thermometer for continuous, non-invasive body temperature monitoring in neonates undergoing…
- Conditions
- Therapeutic Hypothermia, Neonatal Hypoxic-Ischemic Encephalopathy, Neonatal Thermal Management
- Trial name
- MonT HT (NCT07756892)
- Testing
- continous temperature measurement
- Where
- Austria
- Volunteers
- 10 people
- Sponsor
- Medical University of Graz
Hypoxic-ischemic Encephalopathy (HIE)
Therapeutic Hypothermia for Neonatal Hypoxic-Ischemic Encephalopathy in Vietnam
This study aims to evaluate the effectiveness of therapeutic hypothermia in neonates diagnosed with hypoxic-ischemic encephalopathy (HIE).
- Trial name
- HIE-TH Vietnam (NCT07555652)
- Testing
- Therapeutic Hypothermia
- Where
- Vietnam
- Volunteers
- 120 people
- Sponsor
- National Children's Hospital, Vietnam
Hypoxic-Ischemic Encephalopathy
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of RLS-0071 in Newborns With Moderate or Severe Hypoxic-Ischemic Encephalopathy Undergoing Therapeutic Hypothermia
Hypoxic-ischemic encephalopathy (HIE) affects approximately 4,000 to 12,000 persons annually in the United States. Mortality from HIE has been reported up to 60%, with at least 25% of survivors left with significant…
- Trial name
- STAR (NCT05778188)
- Testing
- RLS-0071
- Where
- 22 sites in United States
- Volunteers
- 173 people
- Sponsor
- ReAlta Life Sciences, Inc.
Hypoxic-Ischemic Encephalopathy, Neonatal, Brain Injuries, Hypoxic-Ischemic
Mesenchymal Stem Cells With Cooling Therapy for Infants With Hypoxic-Ischemic Encephalopathy
Hypoxic-ischemic encephalopathy (HIE) is a serious condition in newborns caused by lack of oxygen and blood flow around the time of birth.
- Trial name
- SiSTEM-NEO (NCT07018739)
- Testing
- Wharton's jelly-derived mesenchymal stem cells, 0.9 % Normal Saline
- Where
- Thailand
- Volunteers
- 40 people
- Sponsor
- Mahidol University