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Hypoxia-Ischemia, Brain clinical trials

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NCT ID: NCT04261335 Completed - Clinical trials for Hypoxia-Ischemia, Brain

The Clinical Trial of CL2020 Cells for Neonatal Hypoxic Ischemic Encephalopathy

SHIELD
Start date: March 4, 2020
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the safety and the tolerability of CL2020 cells in hypoxic ischemic encephalopathy neonates with hypothermia therapy. In addition, we will evaluate the efficacy of CL2020 cells for infant development.

NCT ID: NCT03941015 Completed - Acute Kidney Injury Clinical Trials

Tissue Oxygenation During Treatment of Infant Congenital Heart Defects

Start date: December 1, 2018
Phase:
Study type: Observational

Background: Acute kidney injury (AKI) is a common and serious postoperative complication in children with congenital heart disease. In this prospective cohort study, we tested the hypothesis that renal desaturation defined as a 20% decline of renal tissue oxygen saturation (SrtO2) from the baseline value is associated with AKI in infants undergoing ventricular septal defect (VSD) repair with cardiopulmonary bypass (CPB). Methods: Infants aged 1 months to 12 months and scheduled to undergo VSD repair with CPB were eligible. SrtO2 was monitored using a tissue near-infrared spectroscopy. Renal desaturation was defined as a decrease of SrtO2 measurement from the baseline value for more than 20% lasting for more than 60 s. The primary outcome was the incidence of AKI on postoperative 1-3 days according to the Kidney Disease: Improving Global Outcomes criteria. The secondary outcomes included different stages of AKI, duration of postoperative mechanical ventilation, duration of intensive care unit (ICU) and hospital stay, renal replacement therapy (RRT), and in-hospital mortality.

NCT ID: NCT03837717 Completed - Clinical trials for Hypoxic-Ischemic Encephalopathy

The Impact of Holding on Stress and Bonding in Mother-Infant Pairs During Therapeutic Hypothermia

Start date: December 4, 2018
Phase: N/A
Study type: Interventional

This research is being done to try to improve the experience of mothers and babies during therapeutic hypothermia. Currently, mothers are not able to hold their baby during hypothermia treatment. Mothers have reported that not being able to hold their baby during this time is stressful. Additionally, it is known that holding has many benefits for mothers' and babies' psychological and physical health. Therapeutic hypothermia is the standard of care. The experimental interventions of this study are to have mothers hold their babies during this treatment, collect saliva samples from mothers and babies, and test the saliva samples for the hormones cortisol and oxytocin. The investigators will test saliva of infants and their mothers before and after holding. The investigators hope to demonstrate decreased cortisol, a marker for stress, and increased oxytocin, a marker for bonding, in infants and mothers while they are held during therapeutic hypothermia.

NCT ID: NCT03744481 Completed - Clinical trials for Anoxic-Ischemic Encephalopathy

Becoming Children With Perinatal Anoxo-Ischemic Encephalopathy Without Indication of Therapeutic Hypothermia

SARNATUN
Start date: May 19, 2019
Phase:
Study type: Observational

There are 3 levels of severity of anoxo-ischemic encephalopathy (EAI): mild, moderate and severe. Therapeutic hypothermia is beneficial in children with moderate EAI. It is ineffective in severe EAI and may be deleterious if there is no EAI. He continues to question his interest in light EAIs. There are few studies on the becoming of children with a mild anoxic-ischemic encephalopathy and not set hypothermia. The main hypothesis of the study is that term newborns with anoxo-ischemic encephalopathy who did not require therapeutic hypothermia have normal psychomotor development at 2 years.

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: 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: 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: NCT03314779 Completed - Clinical trials for Subarachnoid Hemorrhage

Combined Intracerebral and Jugular Bulb Microdialysis

Start date: August 28, 2017
Phase:
Study type: Observational

The first aim of this study is to investigate the frequency and severity of a specific pathological metabolic pattern, mitochondrial dysfunction, of the brain in comatose patients under neurocritical care. This pattern is recognized as a complication after compromised blood flow to the brain and may be amenable to treatment. The other main aim of this study is to correlate patterns of metabolites between brain and jugular venous blood. It is probable but not proven that jugular venous microdialysis can mirror the global metabolic state of the brain.

NCT ID: NCT03284528 Completed - Asphyxia Neonatorum Clinical Trials

Does Placenta Pathology Predict Outcome of Neonates With Hypoxic Ischemic Encephalopathy?"

Start date: January 1, 2011
Phase: N/A
Study type: Observational

The histology of the placenta of newborn infants with perinatal asphyxia and hypoxic-ischaemic encephalopathy is analysed. There will be an evaluation if placenta could be a biomarker for neurodevelopmental outcome at 18-24 months of age.