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Hypoxia-Ischemia, Brain clinical trials

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NCT ID: NCT03079492 Not yet recruiting - Clinical trials for Hypoxic-Ischemic Encephalopathy

MRI of Neonate With HIE Before and During the Moderate Hypothermia

Start date: June 1, 2017
Phase: N/A
Study type: Observational [Patient Registry]

Moderate hypothermia has been demonstrated to be the effective treatment for neonates with hypoxic-ischemic encephalopathy (HIE). However, few studies reveal the actual alterations in physiological parameters (i.e. brain temperature and cerebral blood flow) of neonates undergoing cooling, especially for HIE lesions. Therefore, this project aims to utilize the magnetic resonance imaging (MRI), i.e. MR thermal imaging and phase contrast MRI to measure the changes of these parameters before and during hypothermia; and then make comparisons with the routine nasopharyngeal and rectal temperature. All these would provide in vivo quantitative data for therapeutic evaluation and promote the optimization.

NCT ID: NCT03079284 Completed - Clinical trials for Hypoxic-Ischemic Encephalopathy

Holding, Stress, and Bonding During Therapeutic Hypothermia

Start date: March 20, 2017
Phase: N/A
Study type: Interventional

Ten infants undergoing therapeutic hypothermia for hypoxic-ischemic encephalopathy will be enrolled in a new protocol that will allow mothers to hold their infants during the hypothermia treatment period. This is a safety study that will assess whether or not there is an increase in adverse event frequency in infants that are held during hypothermia. Parents and NICU nurses will be given a questionnaire after holding is complete investigating their feelings on maternal-infant bonding and safety of the holding protocol.

NCT ID: NCT03079167 Completed - Clinical trials for Hypoxic-Ischemic Encephalopathy

PAEAN - Erythropoietin for Hypoxic Ischaemic Encephalopathy in Newborns

PAEAN
Start date: May 14, 2016
Phase: Phase 3
Study type: Interventional

Double-blind, placebo controlled Phase III trial of erythropoietin for hypoxic ischaemic encephalopathy in infants receiving hypothermia. The study aim is to determine whether Epo in conjunction with hypothermia in infants with moderate/severe hypoxic ischaemic encephalopathy (HIE) will improve neurodevelopmental outcomes at 2 years of age, without significant adverse effects, when compared to hypothermia alone.

NCT ID: NCT03071861 Completed - Clinical trials for Neonatal Encephalopathy

Mild Encephalopathy in the Newborn Treated With Darbepoetin

MEND
Start date: December 1, 2017
Phase: Phase 2
Study type: Interventional

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 less than six hours of age. Participants will be randomized to receive either one dose of Darbepoetin, or placebo within 24 hours of birth. Neurodevelopmental testing (Bayley (III or IV) and Gross Motor Function Assessment) will be performed at 24 months of age. Pharmacokinetics will be assessed on those infants that received Darbe.

NCT ID: NCT03071783 Completed - Clinical trials for Hypoxic Ischemic Encephalopathy

Intra-operative Feed Back on Traction Force During Vacuum Extraction: Safe Vacuum Extraction Alliance

SVEA
Start date: April 1, 2016
Phase: N/A
Study type: Interventional

The objective of the clinical investigation is to test whether intra-operative traction force feed back during vacuum extraction leads to a significant decrease in incidence of brain damage in neonates. By randomization, half of the vacuum extraction patients will be assigned to delivery using a new intelligent handle for vacuum extractions, and half will be assigned to conventional method without traction force measurement.

NCT ID: NCT03024021 Completed - Cardiac Arrest Clinical Trials

Cerebral Oxymetry and Neurological Outcome in Therapeutic Hypothermia

Start date: September 2016
Phase:
Study type: Observational

This study is designed to assess the effect of cerebral oxygen saturation as an early predictor of neurological outcomes in patients undergoing therapeutic hypothermia after cardiac arrest

NCT ID: NCT02991976 Completed - Clinical trials for Hypoxia-Ischemia, Brain

Oxygen Concentration and Recovery After Carotid Endarterectomy

Start date: November 2016
Phase: N/A
Study type: Interventional

This study evaluates effects of high inspiratory oxygen on cerebral tissue oxygenation and patient recovery after carotid endarterectomy. Two group of patient undergoing to carotid with total intravenous anaesthesia will receive either 35% inspired oxygen or 100% oxygen.

NCT ID: NCT02966743 Withdrawn - Clinical trials for Cerebral Ischemia-Hypoxia

Effect of Sedatives on Regional Cerebral Oxygen Saturation

2
Start date: November 2016
Phase: N/A
Study type: Interventional

Compare the changes of regional cerebral oxygen saturation during midazolam or dexmedetomidine sedation for spinal anesthesia in the elderly patients who undergoing femur surgery.

NCT ID: NCT02894866 Recruiting - Clinical trials for Hypoxic-ischemic Encephalopathy

Hyperbaric Oxygen Therapy Improves Outcome of Hypoxic-Ischemic Encephalopathy

Start date: October 2016
Phase: N/A
Study type: Interventional

The purpose of this study is to to evaluate the safety and efficacy of hyperbaric oxygen in term gestation newborn infants with hypoxic-ischemic encephalopathy..

NCT ID: NCT02881970 Recruiting - Clinical trials for Neonatal Hypoxic-ischaemic Encephalopathy

Neonatal Hypoxic Ischemic Encephalopathy : Safety and Feasibility Study of a Curative Treatment With Autologous Cord Blood Stem Cells

NEOSTEM
Start date: February 5, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

Neonatal hypoxic-ischaemic encephalopathy is a dramatic perinatal complication due to brain asphyxia. Neurological and neurosensory sequelae are frequent in survivors, due to neuronal damage and loss. Currently, only total or partial body hypothermia can partially prevent cell loss. However, no treatment exists to restore neuronal functions. Cord blood stem cells are a promising treatment for the near future. The primary objective of this study is to test the safety and feasibility of a curative treatment with autologous cord blood stem cell in neonatal hypoxic-ischaemic encephalopathy. The secondary objectives are to test the efficacy of this curative treatment with cell with neurogenic potential on the prevention of neurologic sequelae, as well as to test the optimum timing of cell preparation administration