N/A N=168 Preemie Hypothermia for Neonatal Encephalopathy
Infant, Newborn · Hypoxia, Brain · Hypoxia-Ischemia, Brain
Primary: Death or Moderate or Severe Disability — 29; 20 Participants
Clinical Trial Search
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N/A N=168 Late Hypothermia for Hypoxic-Ischemic Encephalopathy
Infant, Newborn · Hypoxia, Brain · Hypoxia-Ischemia, Brain
Primary: Death or Moderate or Severe Disability — 19; 22 Participants
N/A N=52 Neonatal Warming to Prevent Hypothermia
Hypothermia
Primary: Temperature at Arrival to Warmer — 36.9; 37.0 degrees Celsius
N/A N=325 TOBY (TOtal Body hYpothermia): a Study of Treatment for Perinatal Asphyxia
Asphyxia Neonatorum · Hypoxia · Encephalopathy
Primary: Combined Incidence of Mortality and Severe Neurodevelopmental Disability in Survivors — 74; 86 participants
Phase 3 N=256 Safety and Efficacy of Hypothermia to Treat Neonatal Hypoxic-Ischemic Encephalopathy
Hypoxic-Ischemic Encephalopathy
Primary: Death — 27; 22 participants
Phase 2 N=50 Neonatal Erythropoietin And Therapeutic Hypothermia Outcomes in Newborn Brain Injury (NEATO)
Hypoxic-ischemic Encephalopathy · Neonatal Encephalopathy · Birth Asphyxia
Primary: Markers of Organ Function — 10; 6; 9; 12 participants
N/A N=10 Holding, Stress, and Bonding During Therapeutic Hypothermia
Hypoxic-Ischemic Encephalopathy
Primary: Frequency of Adverse Events (Safety) — 0 Participants
N/A N=39 Warming Mattress Versus Polyethylene Wrapping to Prevent Hypothermia in Preterm Newborns.
Hypothermia
Primary: Neonatal Intensive Care Unit (NICU) Admission Temperature — 36.5; 36.1 Celsius degrees — p=0.445
N/A N=375 Kangaroo Mother Care to Prevent Hypothermia in Term Infants
Hypothermia · Newborn
Primary: Number of Infants With Axillary Temperature <36.0 Degrees Celsius — 55; 56 Participants
N/A N=101 California Transport Cooling Trial
Hypoxic Ischemic Encephalopathy
Primary: Percentage of Temperatures in Target Range During Transport — 0; 73 Percentage of temperatures — p=<0.001
N/A N=5,716 Optimising Newborn Nutrition During Therapeutic Hypothermia.
Infant, Newborn · Asphyxia Neonatorum · Hypothermia, Induced
Primary: Necrotising Enterocolitis - for the Enteral Nutrition Comparison — NA; NA; NA; 7 Participants
N/A N=329 Therapeutic Hypothermia to Improve Survival After Cardiac Arrest in Pediatric Patients-THAPCA-IH [In Hospital] Trial
Cardiac Arrest
Primary: Survival With Good Neurobehavioral Outcome — 48; 48; 85; 76 Participants — p=0.63
Phase 3 N=295 Therapeutic Hypothermia to Improve Survival After Cardiac Arrest in Pediatric Patients-THAPCA-OH [Out of Hospital] Trial
Cardiac Arrest
Primary: Survival With Good Neurobehavioral Outcome — 27; 15; 111; 107 Participants — p=0.14
N/A N=20 Temperature Monitoring With InnerSense Esophageal Temperature Sensor/Feeding Tube After Birth Through Stabilization in VLBW Infants
Body Temperature
Primary: Mean Axillary Admission Temperature — 36.77; 36.68 Degrees Celsius — p=0.7294
N/A N=25 Delayed Rewarming for Neuroprotection in Infants Following Cardiopulmonary Bypass Surgery
Post-Op Complication
Primary: Infants With Elevated s100b and NSE — 11; 9 Participants
Phase 1 N=4 Pilot Study of Head Cooling in Preterm Infants With Hypoxic Ischemic Encephalopathy
Hypoxic Ischemic Encephalopathy
Primary: Feasibility Trial- the Olympic Cool Cap Will be Applied, Can the Delivered Cap Temperature be Less Than 12 Degrees Without Changing Rectal Temperature. — 2 participants
N/A N=115 Telemedicine to Improve Use of Therapeutic Hypothermia in Rural Settings
Neonatal Encephalopathy
Primary: Time to Initiation of Therapeutic Hypothermia — 4.5 hours
N/A N=40 Pre-warming Prevents Hypothermia in Elective Cesarean Section
Hypothermia
Primary: Maternal Hypothermia — 36.6; 36.4; 36.5; 36.3 Centigrades — p=<0.05
Phase 3 N=1,359 Induction of Mild Hypothermia Following Out-of-hospital Cardiac Arrest
Out-of-hospital Cardiac Arrest
Primary: Number Alive at Hospital Discharge — 187; 183; 62; 76 participants
N/A N=63 Prospective Research in Infants With Mild Encephalopathy
Hypoxic-Ischemic Encephalopathy · Brain Injury · Neonatal Seizure
Primary: Percentage of Infants With Evidence of Neurological Dysfunction, Brain Injury and/or Abnormality. — 28 Participants
N/A N=92 Neuroprotective Effects of Hypothermia Combined With Inhaled Xenon Following Perinatal Asphyxia
Hypoxic Ischaemic Encephalopathy
Primary: Lactate (Lac) / N Acetyl Aspartate (NAA) Ratio on Magnetic Resonance Spectroscopy — 0.25; 0.28 ratio
N/A N=130 Electricity-free Infant Warmer for Newborn Thermoregulation in Rwanda
Hypothermia Neonatal
Primary: Temperature/Effectiveness — 179; 4; 21 Number of infant warmer uses
N/A N=14 Heated Humidified Breathing Circuit Rewarming in Hypothermic Post Cardiopulmonary Bypass Patients.
Hypothermia · Rewarming
Primary: Time to Normothermia — 4.4 hours
Phase 2 N=30 Darbe Administration in Newborns Undergoing Cooling for Encephalopathy
Hypoxic Ischemic Encephalopathy
Primary: The Pharmacokinetic Profile of Darbe After the First Dose During Cooling — 180,866; 26,555 AUC (h*mU/L) — p=0.006
N/A N=49 Temporal Artery Temperature Measurement in Neonates
Newborn Infant
Primary: Temporal Artery Temperature — 37.16 degrees Celsius
N/A N=3,003 Impact of Heart Rate Characteristics Monitoring in Neonates
Sepsis
Primary: Number of Ventilator-free Days — 95.9; 93.6 days — p=0.08
N/A N=21 Detecting Neonatal Hypoglycemia Using Real-Time Continuous Glucose Monitoring (CGM)
Neonatal Hypoglycemia
Primary: Sensor-detected Hypoglycemia — 5; 1 events
N/A N=389 Mild Versus Moderate Therapeutic Hypothermia in Out-of-hospital Cardiac Arrest Patients
Cardiac Arrest
Primary: Number of Participants With Death or Poor Neurologic Outcome at 6 Months — 89; 83 Participants
Phase 2 N=50 Dexmedetomidine Use in Infants Undergoing Cooling Due to Neonatal Encephalopathy (DICE Trial)
Hypoxic-Ischemic Encephalopathy · Pain
Primary: Examine Safety Measures in Infants Receiving DMT to Those Receiving Morphine — 1; 1 Number of serious adverse events
Phase 4 N=52 Early Sodium Intake in Preterm Newborns
Hyponatremia · Premature
Primary: Hyponatremia — 6; 1 Participants — p=0.71