Clinical trials: Targeted Temperature Management
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
Hypoxic Ischemic Encephalopathy
Topiramate in Neonates Receiving Whole Body Cooling for Hypoxic Ischemic Encephalopathy
The goal is to see whether topiramate (an anti-epileptic agent) improves the outcome of babies with neonatal hypoxic encephalopathy who are receiving whole body cooling.
- Trial name
- NCT01765218
- Testing
- Topiramate
- Where
- United States
- Volunteers
- 34 people
- Sponsor
- Kristin R Hoffman
Hypoxic-Ischemic Encephalopathy, Pain
Dexmedetomidine Use in Infants Undergoing Cooling Due to Neonatal Encephalopathy (DICE Trial)
Management of neonatal pain and sedation often includes opioid therapy. A growing body of evidence suggests long-term harm associated with neonatal opioid exposure.
- Trial name
- DICE (NCT04772222)
- Testing
- Dexmedetomidine Hydrochloride, Morphine Sulfate
- Where
- 5 sites in United States
- Volunteers
- 50 people
- Sponsor
- University of Utah
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
Hypoxic Ischemic Encephalopathy
California Transport Cooling Trial
Hypoxic ischemic encephalopathy (HIE) remains a major cause of death and severe disability despite advances in neonatal and perinatal medicine. Therapeutic hypothermia is the single most promising intervention for HIE.
- Trial name
- CTCT (NCT01683383)
- Testing
- Device (servo-regulated cooling), Control (standard practice)
- Where
- 9 sites in United States
- Volunteers
- 101 people
- Sponsor
- Stanford University
Cardiac Arrest
Therapeutic Hypothermia to Improve Survival After Cardiac Arrest in Pediatric Patients-THAPCA-OH [Out of Hospital] Trial
Cardiac arrest is a sudden, unexpected loss of heart function. Therapeutic hypothermia, in which the body's temperature is lowered and maintained several degrees below normal for a period of time, has been used to successfully…
- Trial name
- THAPCA-OH (NCT00878644)
- Testing
- Therapeutic Hypothermia, Therapeutic Normothermia
- Where
- 34 sites in United States, Canada
- Volunteers
- 295 people
- Sponsor
- University of Michigan
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.
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
Post-Op Complication
Delayed Rewarming for Neuroprotection in Infants Following Cardiopulmonary Bypass Surgery
This is an unblinded, single center, randomized study of infants with congenital heart disease undergoing cardiopulmonary bypass surgery, randomized to either the delayed rewarming intervention or to the standard of care (strict…
- Trial name
- NCT03036072
- Testing
- Strict normothermia, Delayed Rewarming
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- Alexa Craig
Cardiac Arrest
Therapeutic Hypothermia to Improve Survival After Cardiac Arrest in Pediatric Patients-THAPCA-IH [In Hospital] Trial
Cardiac arrest is a sudden, unexpected loss of heart function. Therapeutic hypothermia, in which the body's temperature is lowered and maintained several degrees below normal for a period of time, has been used to successfully…
- Trial name
- THAPCA-IH (NCT00880087)
- Testing
- Therapeutic Hypothermia, Therapeutic Normothermia
- Where
- 33 sites in United States, Canada and 1 more
- Volunteers
- 329 people
- Sponsor
- University of Michigan
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
Hypoxic Ischemic Encephalopathy
Darbe Administration in Newborns Undergoing Cooling for Encephalopathy
Selective head cooling or whole body hypothermia has become the standard of care for neonatal hypoxia-ischemia encephalopathy (HIE).
- Trial name
- DANCE (NCT01471015)
- Testing
- Darbepoetin alfa
- Where
- 7 sites in United States
- Volunteers
- 30 people
- Sponsor
- University of Utah
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
Neonatal Encephalopathy
CoolCap Followup Study-Coordination of Participating Centers
This observational study will assess long-term functional outcome of survivors from neonatal encephalopathy who were previously treated with either head cooling or with conventional care in a randomized clinical trial.
- Trial name
- NCT00581581
- Where
- United States
- Volunteers
- 62 people
- Sponsor
- University of Rochester
Infant, Newborn, Asphyxia Neonatorum
Optimising Newborn Nutrition During Therapeutic Hypothermia.
The overarching aim of this project is to determine the optimum enteral and parenteral nutrition strategy for newborns with Hypoxic Ischaemic Encephalopathy (HIE) during and after therapeutic hypothermia.
- Conditions
- Infant, Newborn, Asphyxia Neonatorum, Hypothermia, Induced, Parenteral Nutrition
- Trial name
- NCT03278847
- Testing
- Received enteral (milk) feeds during therapeutic hypothermia, Enteral (milk) feeds withheld during therapeutic hypothermia, Received parenteral nutrition during therapeutic hypothermia
- Where
- 2 sites in United Kingdom
- Volunteers
- 6,030 people
- Sponsor
- Imperial College London