Clinical trials: Hypoxia Neonatal
Hypoxic-Ischemic Encephalopathy
Safety and Efficacy of Hypothermia to Treat Neonatal Hypoxic-Ischemic Encephalopathy
The purpose of this study is to investigate the effectiveness and safety of selective head cooling (SHC) in neonatal hypoxic-ischemic encephalopathy (HIE).
- Trial name
- NCT00890409
- Testing
- Cooling cap (YJW608-04B)
- Where
- China
- Volunteers
- 256 people
- Sponsor
- Fudan University
Asphyxia Neonatorum, Hypoxia
TOBY (TOtal Body hYpothermia): a Study of Treatment for Perinatal Asphyxia
Hypothesis: Prolonged whole body cooling in term infants with perinatal asphyxial encephalopathy reduces death and severe neurodevelopmental disability.
- Conditions
- Asphyxia Neonatorum, Hypoxia, Encephalopathy, Seizures
- Trial name
- NCT00147030
- Testing
- Whole body mild induced hypothermia
- Where
- United Kingdom
- Volunteers
- 325 people
- Sponsor
- Imperial College London
Hypoxic-Ischemic Encephalopathy, Brain Injury
Prospective Research in Infants With Mild Encephalopathy
A multicenter observational pilot study will be conducted to determine the natural history of infants with early diagnosis (≤ 6 hrs of age) of mild neonatal encephalopathy (NE) who are not qualified for therapeutic hypothermia.
- Conditions
- Hypoxic-Ischemic Encephalopathy, Brain Injury, Neonatal Seizure
- Trial name
- PRIME (NCT01747863)
- Testing
- Neurologic examination
- Where
- 7 sites in United States, Canada and 2 more
- Volunteers
- 63 people
- Sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
Hypoxic-Ischemic Encephalopathy, Brain Ischemia Hypoxia
CEUS Evaluation of Hypoxic Ischemic Injury
Neonates presenting with neurologic symptoms require rapid, non-invasive imaging with high spatial resolution and tissue contrast.
- Trial name
- NCT03549520
- Testing
- Sulfur hexafluoride lipid-type A microspheres
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Children's Hospital of Philadelphia
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
PPHN, Persistent Pulmonary Hypertension of the Newborn
Study To Investigate Safety And Efficacy Of Sildenafil In The Newborns With Persistent Pulmonary Hypertension (PPHN)
Sildenafil is efficacious in newborns with persistent pulmonary hypertension and its use will reduce the need for inhaled nitric oxide.
- Conditions
- PPHN, Persistent Pulmonary Hypertension of the Newborn, Hypoxic Respiratory Failure
- Trial name
- NCT01069861
- Testing
- sildanefil
- Where
- United Kingdom
- Volunteers
- 4 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Acute Kidney Injury, Hypoxia-Ischemia, Brain
Tissue Oxygenation During Treatment of Infant Congenital Heart Defects
Background: Acute kidney injury (AKI) is a common and serious postoperative complication in children with congenital heart disease.
- Conditions
- Acute Kidney Injury, Hypoxia-Ischemia, Brain, Mesenteric Ischemia
- Trial name
- NCT03941015
- Where
- China
- Volunteers
- 245 people
- Sponsor
- Beijing Anzhen Hospital
Premature Birth, Neonatal Hypoxic Conditions
Effects of Vanilla on Hypoxic Intermittent Events in Premature Infants
The purpose of this study is to evaluate the effect of vanilla odor on hypoxic intermittent events in premature infants born between 32.0 and 33.6 weeks of gestational age.
- Trial name
- Vanilla (NCT02630147)
- Testing
- Vanilla scent
- Where
- Canada
- Volunteers
- 32 people
- Sponsor
- Université de Sherbrooke
Moderate or Severe Hypoxic-ischemic Encephalopathy in Newborns
A Multi-site Study of Autologous Cord Blood Cells for Hypoxic Ischemic Encephalopathy
This study will test the safety and efficacy of an infusion of a baby's own (autologous) umbilical cord blood as compared with placebo in babies born with history and signs of hypoxic-ischemic brain injury.
- Trial name
- (HIE) (NCT02612155)
- Testing
- Infusion of autologous cord blood
- Where
- United States
- Volunteers
- 35 people
- Sponsor
- Michael Cotten
Hypoxic-Ischemic Encephalopathy
Caffeine for Hypoxic-Ischemic Encephalopathy
Hypoxic-ischemic encephalopathy (HIE) due to perinatal asphyxia is common and often fatal. Therapeutic hypothermia reduces mortality and morbidity in infants with HIE.
- Trial name
- NCT03913221
- Testing
- Caffeine Citrate 5 mg/kg, Caffeine Citrate 10 mg/kg
- Where
- United States
- Volunteers
- 17 people
- Sponsor
- University of North Carolina, Chapel Hill
Neonatal Encephalopathy, Hypoxic-Ischemic Encephalopathy Mild
Mild Encephalopathy in the Newborn Treated With Darbepoetin
This is a Phase II multicenter placebo-controlled randomized, feasibility/safety trial. Infants >34 week gestational age with perinatal acidemia and mild neonatal encephalopathy on the modified Sarnat neurologic examination at…
- Trial name
- MEND (NCT03071861)
- Testing
- Darbepoetin Alfa, Normal Saline
- Where
- United States
- Volunteers
- 28 people
- Sponsor
- University of New Mexico
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
Late Hypothermia for Hypoxic-Ischemic Encephalopathy
This study is a randomized, placebo-controlled, clinical trial to evaluate whether induced whole-body hypothermia initiated between 6-24 hours of age and continued for 96 hours in infants ≥ 36 weeks gestational age with…
- Conditions
- Infant, Newborn, Hypoxia, Brain, Hypoxia-Ischemia, Brain, Encephalopathy, Hypoxic-Ischemic
- Trial name
- NCT00614744
- Testing
- Hypothermia, Normothermic Control
- Where
- 22 sites in United States
- Volunteers
- 168 people
- Sponsor
- NICHD Neonatal Research Network
Cerebral Palsy, Stroke
Spinal Stimulation and Mobility Devices
This research study will combine non-invasive spinal stimulation with an ankle exoskeleton to examine the acute impact of the stimulation on gait in children with cerebral palsy.
- Conditions
- Cerebral Palsy, Stroke, Premature Birth, Hypoxic-Ischemic Encephalopathy
- Trial name
- NCT05520359
- Testing
- Mobility Device, Spinal Stimulation
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- University of Washington
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
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
Optimizing (Longer, Deeper) Cooling for Neonatal Hypoxic-Ischemic Encephalopathy(HIE)
The Optimizing Cooling trial will compare four whole-body cooling treatments for infants born at 36 weeks gestational age or later with hypoxic-ischemic encephalopathy: (1) cooling for 72 hours to 33.5°C; (2) cooling for 120…
- Conditions
- Infant, Newborn, Hypoxia, Brain, Hypoxia-Ischemia, Brain, Encephalopathy, Hypoxic-Ischemic
- Trial name
- NCT01192776
- Testing
- Whole-body Cooling
- Where
- 19 sites in United States
- Volunteers
- 364 people
- Sponsor
- NICHD Neonatal Research Network
Hypoxic Ischemic Encephalopathy
Pilot Study of Head Cooling in Preterm Infants With Hypoxic Ischemic Encephalopathy
The hypothesis is that premature infants' can have enough cooling applied to cool their brain to decrease CNS injury without cooling their body.
- Trial name
- NCT00620711
- Testing
- Olympic Cool Cap
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Vanderbilt University
Hypoxemia
Oxygen Saturation Alarms in the Neonatal Intensive Care Unit
Infants will be observed in the neonatal intensive care unit for 4 hours. The observer will note the timing of oxygen saturation alarms, staff response, and interrupted staff activities.
- Trial name
- NCT01085539
- Where
- 3 sites in United States
- Volunteers
- 50 people
- Sponsor
- Medtronic - MITG
Cerebral Palsy, Hypoxia-Ischemia, Brain
The TOBY Children Study
The aim of this study is to determine the efficacy of therapeutic hypothermia following perinatal asphyxia on neurological and neuropsychological outcomes and also to assess academic attainment and any additional health, societal…
- Trial name
- NCT01092637
- Where
- United Kingdom
- Volunteers
- 280 people
- Sponsor
- Imperial College London