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Hypoxia-Ischemia, Brain clinical trials

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NCT ID: NCT03162653 Recruiting - Clinical trials for Infant, Newborn, Diseases

Effect of Allopurinol for Hypoxic-ischemic Brain Injury on Neurocognitive Outcome

ALBINO
Start date: March 25, 2018
Phase: Phase 3
Study type: Interventional

Neonatal hypoxic-ischemic encephalopathy (HIE) is a major cause of death or long-term disability in infants born at term in the western world, affecting about 1-4 per 1.000 life births and consequently about 5-20.000 infants per year in Europe. Hypothermic treatment became the only established therapy to improve outcome after perinatal hypoxic-ischemic insults. Despite hypothermia and neonatal intensive care, 45-50% of affected children die or suffer from long-term neurodevelopmental impairment. Additional neuroprotective interventions, beside hypothermia, are warranted to further improve their outcome. Allopurinol is a xanthine oxidase inhibitor and reduces the production of oxygen radicals and brain damage in experimental, animal, and early human studies of ischemia and reperfusion. This project aims to evaluate the efficacy and safety of allopurinol administered immediately after birth to near-term infants with HIE in addition to hypothermic treatment.

NCT ID: NCT03123081 Recruiting - Clinical trials for Hypoxic-Ischemic Encephalopathy

Role of Umbilical Cord Milking in the Management of Hypoxic-ischemic Encephalopathy in Neonates

Start date: January 1, 2018
Phase: N/A
Study type: Interventional

The purpose of this study is to investigate the efficacy and safety of umbilical cord milking in depressed neonates at birth for prevention of hypoxic ischemic encephalopathy.

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

NCT ID: NCT02854579 Recruiting - Clinical trials for Hypoxic-Ischemic Encephalopathy

Neural Progenitor Cell and Paracrine Factors to Treat Hypoxic Ischemic Encephalopathy

Start date: January 2013
Phase: N/A
Study type: Interventional

The purpose of this study is to investigate the efficacy and safety of allogenic neural progenitor cell and paracrine factors of human mesenchymal stem cells for patients with moderate/severe Hypoxic-Ischemic Encephalopathy

NCT ID: NCT02621944 Recruiting - Clinical trials for Hypoxic Ischemic Encephalopathy

Melatonin as a Neuroprotective Therapy in Neonates With HIE Undergoing Hypothermia

Start date: November 2016
Phase: Early Phase 1
Study type: Interventional

Hypoxic-Ischemic Encephalopathy (HIE) occurs in 20 per 1000 births. Only 47% of neonates treated with the state of the art therapy (induced systemic hypothermia) have normal outcomes. Therefore, other promising therapies that potentially work in synergy with hypothermia to improve neurologic outcomes need to be tested. One potential agent is melatonin. Melatonin is a naturally occurring substance produced mainly from the pineal gland. Melatonin is widely known for its role in regulating the circadian rhythm, but it has many other effects that may benefit infants with HI injury. Melatonin serves as a free radical scavenger, decreases inflammatory cytokines, and stimulates anti-oxidant enzymes. Therefore, melatonin may interrupt several key components in the pathophysiology of HIE, in turn minimizing cell death and improving outcomes. The research study will evaluate the neuroprotective properties and appropriate dose of Melatonin to give to infants undergoing therapeutic hypothermia for hypoxic ischemic encephalopathy.

NCT ID: NCT02578823 Recruiting - Clinical trials for Hypoxic Ischemic Encephalopathy

Targeted Temperature Management After In-Hospital Cardiac Arrest

TTM36-IHCA
Start date: January 2016
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether targeted temperature management at 36.0˚C(TTM-36) in patients who remain unconscious after resuscitation from in-hospital cardiac arrest(IHCA) will reduce death and disability compared with fever control. For this purpose, the current pilot study will be undertaken to establish the feasibility, safety, and surrogate outcomes of hypoxic-ischemic brain injury in 60 patients who remain unconscious after resuscitation from IHCA. Eligible patients will be randomly assigned in a 2:1 ratio to either TTM-36(n=40) or conventional treatment group(n=20). Randomization will be performed with stratification according to initial rhythm (shockable vs. non-shockable).

NCT ID: NCT02252848 Recruiting - Clinical trials for Hypoxic Ischemic Encephalopathy (HIE)

Phase I Clinical Trial to Determine the Safety of Clonidine in Infants With HIE During Therapeutic Hypothermia.

Start date: March 2014
Phase: Phase 1
Study type: Interventional

Hypoxic ischemic encephalopathy (HIE) occurs in ~ 2-4/1000 term infants and is a major cause of neonatal morbidity and mortality. To date, therapeutic hypothermia started within 6 h of birth is the only intervention known to be effective in reducing the morbidity and mortality of HIE. Hypothermia does not totally reverse the injury in many infants and is associated with side effects that may compromise its effectiveness. Low dose morphine is often used to reduce shivering in infants undergoing therapeutic hypothermia, but escalating doses of sedatives/analgesics are often required. Escalating doses of opioids and benzodiazepines causes respiratory depression and can either cause the need for or prolong mechanical ventilation.Agonists to the central a2 - adrenergic receptors are more effective at reducing postoperative shivering than opioid receptor agonists and provide analgesia and sedation without respiratory depression. The most desirable sedative-analgesic agent used in infants with HIE would: (a) have an excellent safety profile, (b) reduce shivering, (c) provide adequate analgesia and sedation, (d) cause minimal respiratory depression, (e) preserve cerebrovascular autoregulation, and (f) confer neuroprotection.

NCT ID: NCT01962233 Recruiting - Clinical trials for Hypoxic Ischemic Encephalopathy

Umbilical Cord Derived Mesenchymal Stem Cells Therapy in Hypoxic Ischemic Encephalopathy

Start date: September 2013
Phase: Phase 1
Study type: Interventional

This study is to evaluate the safety and efficacy of Umbilical Cord Derived Mesenchymal Stem Cells transplantation in hypoxic ischemic encephalopathy.

NCT ID: NCT01646619 Recruiting - Clinical trials for Severe Hypoxic Ischemic Encephalopathy

Efficacy Study of Hypothermia Plus Magnesium Sulphate(MgSO4) in the Management of Term and Near Term Babies With Hypoxic Ischemic Encephalopathy

MagCool
Start date: May 2012
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess whether the addition of a drug such as Magnesium sulphate while providing therapeutic hypothermia (or cooling) to babies who are asphyxiated at birth provides additional benefit to the babies' survival and outcome compared to cooling alone.