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Hypoxia-Ischemia, Brain clinical trials

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NCT ID: NCT03640494 Completed - Clinical trials for Hypoxic-Ischemic Encephalopathy

Bedside Optical Retinal Assessment of Hypoxic Ischemic Encephalopathy in Infants

Start date: August 28, 2018
Phase:
Study type: Observational

The purpose of this study is to develop a novel noninvasive bedside optical coherence tomography (OCT) imaging technique in newborn infants with HIE that improves our ability to assess the range of retinal effects from HIE and to diagnose and monitor treatments of HIE.

NCT ID: NCT03635450 Completed - Clinical trials for Moderate to Severe Hypoxic-ischemic Encephalopathy

Study of hCT-MSC in Newborn Infants With Moderate or Severe HIE

Start date: December 27, 2018
Phase: Phase 1
Study type: Interventional

To determine the safety of single and repeated intravenous doses of hCT-MSC in newborn infants with HIE.

NCT ID: NCT03550612 Not yet recruiting - Clinical trials for Neonatal Hypoxic Ischemic Encephalopathy

Neonatal Hypoxic Ischemic Encephalopathy:Early Diagnosis and Management of Comorbidities

Start date: February 1, 2019
Phase:
Study type: Observational

Perinatal asphyxia is common cause of acquired neonatal brain injury in neonates associated with hypoxic-ischemic encephalopathy, leading to long-term neurologic complication or death. In 2000, the neonatal mortality rate in Egypt was found to be 25 per 1000 live birth. In this survey, hypoxic ischemic encephalopathy accounts for 18% of neonatal mortality and is the second most common cause of neonatal death.

NCT ID: NCT03549520 Recruiting - Clinical trials for Hypoxic-Ischemic Encephalopathy

CEUS Evaluation of Hypoxic Ischemic Injury

Start date: December 1, 2020
Phase: Phase 3
Study type: Interventional

Neonates presenting with neurologic symptoms require rapid, non-invasive imaging with high spatial resolution and tissue contrast. The purpose of this study is to evaluate brain perfusion using contrast-enhanced ultrasound CEUS in bedside monitoring of neonates and infants with hypoxic ischemic injury. Investigational CEUS scan will be performed separately from clinically indicated conventional US, in the ICU. Subjects will be scanned with CEUS at two different time-points (at the time HII is first suspected or diagnosed and at time of MRI scan), separately from clinically indicated ultrasound. The CEUS scan will be interpreted by the sponsor-investigator. The study will be conducted at one site, The Children's Hospital of Philadelphia. It is expected that up to 100 subjects will be enrolled per year, for up to two years, for a total enrollment of up to 200 subjects.

NCT ID: NCT03543371 Completed - Insomnia Clinical Trials

Neuropsychological Outcome After Cardiac Arrest

Start date: July 13, 2018
Phase:
Study type: Observational

This study is a sub-study to the large pragmatic Target Temperature Management 2 Trial (TTM2-trial, ClinicalTrials.gov Identifier: NCT02908308), assessing effectiveness of controlled hypothermia after out-of-hospital cardiac arrest (OHCA). This study is designed to provide detailed information on cognition after OHCA and its relationship to associated factors as emotional function, fatigue, and sleep. A secondary aim is to utilize this information to validate a neurocognitive screening battery used 6 months after OHCA in the TTM2-trial. Approximately 7 and 24 months after OHCA, survivors at selected TTM2 study sites will perform a standardized neuropsychological assessment including performance-based tests of cognition and questionnaires of behavioral and emotional function, fatigue, and insomnia. At 1:1 ratio, a control group of myocardial infarction (MI) patients but no occurrence of cardiac arrest will be recruited and perform the same test battery. Group differences at 7 and 24 months will be analyzed per cognitive domain (verbal, visual/constructive, short-term working memory, episodic memory, processing speed, executive functions). Results of the OHCA survivors on the TTM2 neurocognitive screening battery will be compared with neuropsychological test results at 7 months time.

NCT ID: NCT03534466 Terminated - Cerebral Infarction Clinical Trials

Evaluation of Long-Term Gait Development in Infants With Neonatal Encephalopathy Using Infant Treadmill

Start date: December 1, 2020
Phase: N/A
Study type: Interventional

There have been many studies on the use of running training in older children to improve gait development in children with cerebral palsy. The aim of our study was to conduct early treadmill training in infants who were highly suspected of cerebral palsy and to follow up on their long-term gait development.

NCT ID: NCT03527498 Withdrawn - Cerebral Infarction Clinical Trials

Evaluation of Long-term Neurodevelopment in Neonatal Encephalopathy by Infant Treadmill

Start date: December 1, 2020
Phase: N/A
Study type: Interventional

There is no international application of infant running stimulation system to evaluate the brain injury in children with various stages of nerve and motor development in a large sample of studies. The study of neonatal brain injury is only limited to intraventricular hemorrhage(IVH),periventricular leukomalacia(PVL), Down's syndrome(DS), premature birth of these four conditions, and the number of samples in the single digits, there is no representative of the disease population. Therefore, from the newborn to the infant development of the critical period, the investigator will refer to the previous treadmill parameters set on the research results, optimize the application of neonatal treadmill. The study hypothesized that neonatal treadmill stimulation with brain-injured children could improve his / her staggered gait characteristics and long-term nerve development through large sample data. It is important to preserve and analyze the gait characteristics and the changes of nerve development in every stage of growth and development of neonates with brain injury so as to provide clinical evidence for rehabilitation intervention. It is of great significance to judge whether this technique can be used in the early stage of brain injury in neonates.

NCT ID: NCT03485781 Completed - Cardiac Arrest Clinical Trials

Propofol-induced EEG Changes in Hypoxic Brain Injury

PROPEA3
Start date: October 12, 2017
Phase:
Study type: Observational

PROPEA3 is a prospective observational study investigating the recovery of propofol-induced EEG slow-wave activity and its association with neurological outcome after cardiac arrest.

NCT ID: NCT03352310 Recruiting - Clinical trials for Hypoxic-Ischemic Encephalopathy

Feasibility and Safety of Umbilical Cord Blood Transfusion in the Treatment of Neonatal Cerebral Ischemia and Anemia

Start date: April 16, 2018
Phase: Phase 1
Study type: Interventional

The study is to investigate the feasibility and safety of autologous umbilical cord blood transfusion to treat the newborn infants with presence of clinical indications of neonatal hypoxic-ischemia encephalopathy (HIE) and anemia. Umbilical cord blood (UCB) is collected following labor and is transfused intravenously within 48 hours after the birth. Newborn infant without UCB available recieves the standard care will be enrolled as control group. Following the autologous UCB transfusion in the study group or standard care in the control group, HIE subjects will be followed for 2 years for survival and neurodevelopmental outcomes and anemia subjects will be followed for 6 months to assess the survival and change of hematocrit and hemoglobin levels.

NCT ID: NCT03327467 Available - Cerebral Palsy Clinical Trials

Expanded Access Protocol: Umbilical Cord Blood Infusions for Children With Brain Injuries

Start date: n/a
Phase:
Study type: Expanded Access

This protocol is designed to enable access to intravenous infusions of banked umbilical cord blood (CB), that is thawed and not more than minimally manipulated, for children with various brain disorders. Children with cerebral palsy, congenital hydrocephalus, apraxia, stroke, hypoxic brain injury and related conditions will be eligible if they have normal immune function and do not qualify for, have previously participated in, or are unable to participate in an active cell therapy clinical trial at Duke Medicine. For the purpose of this protocol the term children refers to patients less than 26 years of age. Cord blood is administered as a cellular infusion without prior treatment with chemotherapy or immunosuppression. The mechanism of action is through paracrine signaling of cord blood monocytes inducing endogenous cells to repair existing damage.