Phase 3 N=500 High-dose Erythropoietin for Asphyxia and Encephalopathy
Neonatal Encephalopathy · Birth Asphyxia
Primary: Number of Participants With Death or Neurodevelopmental Impairment — 126; 110 Participants
Clinical Trial Search
Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
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=168 Late Hypothermia for Hypoxic-Ischemic Encephalopathy
Infant, Newborn · Hypoxia, Brain · Hypoxia-Ischemia, Brain
Primary: Death or Moderate or Severe Disability — 19; 22 Participants
Phase 3 N=1 CEUS Evaluation of Hypoxic Ischemic Injury
Hypoxic-Ischemic Encephalopathy · Brain Ischemia Hypoxia
Primary: Detection of Brain Perfusion Abnormalities Using Contrast-enhanced Ultrasound — 1; 0 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=35 A Multi-site Study of Autologous Cord Blood Cells for Hypoxic Ischemic Encephalopathy
Moderate or Severe Hypoxic-ischemic Encephalopathy in Newborns
Primary: Survival at One Year — 16; 17 Participants
Phase 1 N=9 Caffeine for Hypoxic-Ischemic Encephalopathy
Hypoxic-Ischemic Encephalopathy
Primary: Area Under Plasma Concentration-time at Time t (AUC0-t) for Caffeine — 1137.36; 1177.94; 2213.26; 2768.25 mg*hr/L
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=11 Therapeutic Intervention Supporting Development From NICU to 6 Months for Infants Post Hypoxic-Ischemic Encephalopathy
Cerebral Palsy · Hypoxic-Ischemic Encephalopathy
Primary: Feasibility of the Neonatal Intensive Care Unit Component of the Intervention. — 0; 1 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=168 Preemie Hypothermia for Neonatal Encephalopathy
Infant, Newborn · Hypoxia, Brain · Hypoxia-Ischemia, Brain
Primary: Death or Moderate or Severe Disability — 29; 20 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=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 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=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=10 Holding, Stress, and Bonding During Therapeutic Hypothermia
Hypoxic-Ischemic Encephalopathy
Primary: Frequency of Adverse Events (Safety) — 0 Participants
N/A N=111 Cerebral Oxygenation and Autoregulation in Preterm Infants
Intraventricular Hemorrhage of Prematurity · Complications of Prematurity
Primary: Mortality Before Hospital Discharge — 11 Participants
N/A N=16 American Heart Association- Stroke/Hypoxia Study
Stroke
Primary: Number of Participants With Adverse Events — 1; 11; 2; 10 Participants
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=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=29 Targeting Normoxia in Neonates With Cyanotic Congenital Heart Disease in the Intra-operative and Immediate Post-operative Period
Hypoplastic Left Heart Syndrome · Total Anomalous Pulmonary Venous Return · Truncus Arteriosus
Primary: Systemic Oxidative Stress Based on Thiobarbituric Acid Reactive Substances (TBARS) — 1.21; 1.93; 1.09; 1.77 Fold Change from Baseline — p=<0.01
N/A N=77 Brain Imaging and Developmental Follow up of Infants Treated With Erythropoietin
Prematurity
Primary: Full Scale IQ, Performance IQ, Verbal IQ, Executive Function — 79; 91; 103; 83 standardized score on a scale
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 2 N=62 Erythropoetin Neuroprotection for Neonatal Cardiac Surgery
Congenital Heart Disease · Hypoplastic Left Heart Syndrome · Transposition of the Great Arteries
Primary: Relative Difference in Total Maturity Score (TMS) From Preoperative Brain MRI to 7 Day Postoperative MRI — 12.1; 9.44 Percentage
Phase 2 N=256 Effects of Delayed Cord Clamp and/or Indomethacin on Preterm Infant Brain Injury
Intraventricular Hemorrhage · Periventricular Leukomalacia · Brain Injury
Primary: Percent of Survivors With no Severe IVH (Grades 3 or 4) or PVL — 22.2; 14.9; 17.1; 10.9 percent of participants
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
Phase 2 N=96 Normobaric Hyperoxia for Intracerebral Hemorrhage
Normobaric Hyperoxia · Intracerebral Hemorrhage
Primary: Percentage of Patients With mRS 0-3 — 39; 27 Participants
Phase 2 N=12 Safety of Clonidine in Infants With Hypoxic Ischemic Encephalopathy During Therapeutic Hypothermia
Encephalopathy, Hypoxic-Ischemic
Primary: Steady State Clonidine Blood Levels During Hypothermia — 0.6 ng/ml
Phase 1 N=20 Reperfusion With Cooling in Cerebral Acute Ischemia
Stroke, Acute
Primary: Number of Participants With Reperfusion Injury Hemorrhagic Transformation — 3 participants
N/A N=12 Acute Intermittent Hypoxia in Traumatic Brain Injury
Brain Injuries, Traumatic
Primary: Change in Vitals at Visit 2 — 0 Participants