Clinical trials: Targeted Temperature Management
Neonatal Encephalopathy, Feeding; Difficult, Newborn
OMT to Improve Feeding After Hypothermia
The goal of this study is to determine if infants with neonatal encephalopathy will achieve full oral feeds faster after therapeutic hypothermia has completed if they are treated with osteopathic manipulative treatment.
- Trial name
- NCT03380013
- Testing
- Osteopathic Manipulative Treatment (OMT)
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- MaineHealth
Hypoxic-ischemic Encephalopathy, Neonatal Encephalopathy
Neonatal Erythropoietin And Therapeutic Hypothermia Outcomes in Newborn Brain Injury (NEATO)
Hypoxic-ischemic encephalopathy (HIE), a condition of reduced blood and oxygen flow to a baby's brain near the time of birth, may cause death or neurologic disability.
- Conditions
- Hypoxic-ischemic Encephalopathy, Neonatal Encephalopathy, Birth Asphyxia
- Trial name
- NEATO (NCT01913340)
- Testing
- Erythropoietin, Normal saline
- Where
- 7 sites in United States
- Volunteers
- 50 people
- Sponsor
- University of California, San Francisco
Infant, Newborn, Hypoxia, Brain
Preemie Hypothermia for Neonatal Encephalopathy
This study is a randomized, controlled trial to assess safety and effectiveness of whole body hypothermia for 72 hours in preterm infants 33-35 weeks gestational age (GA) who present at <6 hours postnatal age with moderate to…
- Conditions
- Infant, Newborn, Hypoxia, Brain, Hypoxia-Ischemia, Brain, Encephalopathy, Hypoxic-Ischemic
- Trial name
- NCT01793129
- Testing
- Hypothermia, Normothermic Control
- Where
- 18 sites in United States
- Volunteers
- 168 people
- Sponsor
- NICHD Neonatal Research Network
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
Acute Kidney Injury, Hypoxic-Ischemic Encephalopathy
PK and Safety of Caffeine in Neonates With Hypoxic Ischemic Encephalopathy Receiving Therapeutic Hypothermia
A phase 1 study investigating the tolerability and pharmacokinetics of caffeine citrate in neonates with hypoxic ischemic encephalopathy receiving therapeutic hypothermia.
- Conditions
- Acute Kidney Injury, Hypoxic-Ischemic Encephalopathy, Caffeine
- Trial name
- NCT05295784
- Testing
- Caffeine citrate
- Where
- 2 sites in United States
- Sponsor
- University of Arkansas
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
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
Brain Injuries, Traumatic
Therapeutic Hypothermia for Severe Traumatic Brain Injury in Japan
The purpose of this trial is to determine if mild hypothermia therapy, for severe head trauma patients, improves neurological outcome.
- Trial name
- NCT00134472
- Testing
- Therapeutic mild hypothermia
- Where
- 43 sites in Japan
- Volunteers
- 150 people
- Sponsor
- Yamaguchi University Hospital
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
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
Hypoxic Ischemic Encephalopathy of Newborn, Feeding Patterns
Continuous Versus Bolus Feeding in Neonates With Hypoxic Ischemic Encephalopathy
Therapeutic hypothermia (TH) is accepted worldwide as a standard of care for infants born at or beyond 36 weeks gestational age with moderate-to-severe hypoxic ischaemic encephalopathy (HIE).
- Trial name
- NCT06447155
- Testing
- Bolus feeding, Continuous feeding
- Where
- Turkey (Türkiye)
- Volunteers
- 60 people
- Sponsor
- Istanbul Training and Research Hospital
Neonatal Encephalopathy
Telemedicine to Improve Use of Therapeutic Hypothermia in Rural Settings
This pilot intervention trial will assess the feasibility of a live consultation between community hospital providers and tertiary care providers employing a novel teleconsult platform, Maine Neonatal Encephalopathy Teleconsult…
- Trial name
- NCT03706417
- Testing
- Telemedicine consult
- Where
- United States
- Volunteers
- 115 people
- Sponsor
- MaineHealth
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
Congenital Heart Defects, Brain Ischemia
Hypothermia Therapy in Pediatric Cardiac Intensive Care Unit for Suspected for Brain Injury
Cardiac pathology is a major risk for brain injury and neurodevelopmental deficit. The most common cause of cardiac pathology is congenital heart defects (CHD) about 4-8/1000 live births a year.
- Conditions
- Congenital Heart Defects, Brain Ischemia, Hypoxia Brain, Child
- Trial name
- Coolheart (NCT02395276)
- Testing
- Whole body hypothermia
- Volunteers
- 75 people
- Sponsor
- Sheba Medical Center
Hypoxic Ischaemic Encephalopathy
Correlation of Risk Factors and Severity of Hypoxic-ischaemic Encephalopathy
The first aim of this study is to analyse perinatal risk factors leading to hypoxic ischaemic encephalopathy in term and near term neonates born in Switzerland who were admitted to the neonatal and intensive care units offering…
- Trial name
- NCT02800018
- Testing
- risk factors
- Where
- Switzerland
- Volunteers
- 160 people
- Sponsor
- University Children's Hospital, Zurich
Neonatal Encephalopathy
Enteral Feeding and Splanchnic NIRS Values in Infants With Neonatal Encephalopathy (NE)
The research team plans to administer trophic enteral feeds to infants with Neonatal Encephalopathy that are undergoing therapeutic hypothermia.
- Trial name
- NCT05471336
- Testing
- Enteral Feeding
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- NYU Langone Health
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
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
Hypoxia-Ischemia, Brain
The Clinical Trial of CL2020 Cells for Neonatal Hypoxic Ischemic Encephalopathy
The purpose of this study is to evaluate the safety and the tolerability of CL2020 cells in hypoxic ischemic encephalopathy neonates with hypothermia therapy.
- Trial name
- SHIELD (NCT04261335)
- Testing
- CL2020 cells
- Where
- Japan
- Volunteers
- 9 people
- Sponsor
- Nagoya University
Hypoxic-Ischemic Encephalopathy
Holding, Stress, and Bonding During Therapeutic Hypothermia
Ten infants undergoing therapeutic hypothermia for hypoxic-ischemic encephalopathy will be enrolled in a new protocol that will allow mothers to hold their infants during the hypothermia treatment period.
- Trial name
- NCT03079284
- Testing
- Holding during cooling
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Alexa Craig