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Hypoxia-Ischemia, Brain clinical trials

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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: NCT02826941 Completed - Clinical trials for Hypoxic Ischemic Encephalopathy

Moderate Hypothermia in Neonatal Hypoxic Ischemic Encephalopathy

Start date: June 1999
Phase: Phase 2
Study type: Interventional

This study was a multicenter, randomized, controlled pilot trial of moderate systemic hypothermia (33°C) vs normothermia (37°C) for 48 hours in infants with neonatal encephalopathy instituted within 6 hours of birth or hypoxic-ischemic event.

NCT ID: NCT02800018 Completed - Clinical trials for Hypoxic Ischaemic Encephalopathy

Correlation of Risk Factors and Severity of Hypoxic-ischaemic Encephalopathy

Start date: June 2016
Phase:
Study type: Observational

The first aim of this study is to analyse perinatal risk factors leading to hypoxic ischaemic encephalopathy in term and near term neonates born in Switzerland who were admitted to the neonatal and intensive care units offering hypothermia therapy. Further, investigators would like to analyse the influence of these perinatal risk factors on the severity of encephalopathy during and after hypothermia therapy.

NCT ID: NCT02700854 Completed - Perinatal Asphyxia Clinical Trials

Hypoxic-Ischemic Encephalopathy Therapy Optimization in Neonates for Better Neuroprotection With Inhalative CO2

HENRIC
Start date: February 2016
Phase: Phase 1
Study type: Interventional

This is a Phase I, open-label, single center trial to evaluate the feasibility and safety of low concentration CO2 gas mixture (5% CO2 + 95% air) inhalation in asphyxiated, cooled, mechanically ventilated newborns at risk of hypocapnia with The hypothesis is that hypocapnia, which is driven by hyperventilation in the presence of metabolic acidosis, is deleterious to the injured brain and can be safely avoided with low concentration CO2 inhalation.

NCT ID: NCT02700828 Completed - Clinical trials for Hypoxic-Ischemic Encephalopathy

Hydrocortisone Treatment In Systemic Low Blood Pressure During Hypothermia in Asphyxiated Newborns

CORTISoL
Start date: February 2016
Phase: Phase 2/Phase 3
Study type: Interventional

This is a prospective, randomized, double-blind, placebo controlled, single center study to compare low dose hydrocortisone vs placebo in systemic low blood pressure during hypothermia treatment in asphyxiated newborns. Patients will be allocated to one of the treatment arms (hydrocortisone or placebo) while receiving conventional inotropic therapy as needed. The hypothesis is that cooled asphyxiated neonates develop relative adrenal insufficiency that may contribute to hypotension and lower efficacy of inotropic therapy in this patient population. Thus, the investigators are planning to measure initial serum cortisol levels and investigate the cardiovascular effects of low dose hydrocortisone supplementation besides conventional inotropic therapy in a placebo-controlled fashion.

NCT ID: NCT02683915 Completed - Clinical trials for Hypoxic Ischemic Encephalopathy

Reno-protective Effect of Brain Cooling in Newborn With Hypoxia

Start date: September 2015
Phase:
Study type: Observational

This study aims to determine the effect of therapeutic hypothermia on reducing AKI in term and late-preterm infants with hypoxic ischemic encephalopathy as estimated by measurment of serum(s) neutrophil gelatinase-associated lipocalin(NGAL) and serum (s) cystatin-C.

NCT ID: NCT02676063 Active, not recruiting - Clinical trials for Ischemic-Hypoxic Encephalopathy

Long Term Prognostic of Neonatal Hypoxic Ischemic Encephalopathy With Hypothermia Treatment

LyTONEPAL
Start date: September 2015
Phase:
Study type: Observational

The primary objective is to evaluate neonatal characteristics, and biological and clinical investigations as predictive factors of death, or of severe and moderate neurodevelopmental disability at 3 years, in a large population-based cohort of full-term and late preterm neonates with moderate or severe HIE. Contrary to most previous studies which have often analyzed the accuracy of one factor among all other clinical investigations, the investigators objective's is to seek a relevant combination of several factors among the following list: - Neonatal characteristics: gestational age and birthweight, maternal disease, acute intrapartum event, delivery mode, acidosis, neurological examination, place of birth and neonatal transfer - Laboratory investigations: pH, lactates and new biological markers as detailed below - Clinical investigations: aEEG, EEG, MRI, diffusion-weighted MRI

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: NCT02612155 Completed - Clinical trials for Moderate or Severe Hypoxic-ischemic Encephalopathy in Newborns

A Multi-site Study of Autologous Cord Blood Cells for Hypoxic Ischemic Encephalopathy

(HIE)
Start date: March 30, 2017
Phase: Phase 2
Study type: Interventional

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.

NCT ID: NCT02605733 Completed - Premature Birth Clinical Trials

The Neu-Prem Trial: Neuromonitoring of Preterm Newborn Brain During Birth Resuscitation

Neu-Prem
Start date: October 2015
Phase:
Study type: Observational

The purpose of this study is to characterize the normal brain function of premature infants (23 to 31+6 weeks GA) during birth transition and through the first 72 hours of life.