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Hypoxia-Ischemia, Brain clinical trials

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NCT ID: NCT05581927 Withdrawn - Brain Injury Clinical Trials

Whole-Body Hypothermia for Neonates With Hypoxic-Ischemic Encephalopathy(HIE)

Start date: October 1, 2022
Phase: N/A
Study type: Interventional

Among term infants, hypoxic-ischemic encephalopathy due to acute perinatal asphyxia remains an important cause of brain injury in childhood. Infants with moderate encephalopathy have a 10 percent risk of death, and those who survive have a 30 percent risk of disabilities. Sixty percent of infants with severe encephalopathy die, and many, if not all, survivors are disabled. Whole-body hypothermia reduces the risk of death or disability in infants with moderate or severe hypoxic-ischemic encephalopathy.

NCT ID: NCT05295784 Withdrawn - Acute Kidney Injury Clinical Trials

PK and Safety of Caffeine in Neonates With Hypoxic Ischemic Encephalopathy Receiving Therapeutic Hypothermia

Start date: May 8, 2024
Phase: Phase 1
Study type: Interventional

A phase 1 study investigating the tolerability and pharmacokinetics of caffeine citrate in neonates with hypoxic ischemic encephalopathy receiving therapeutic hypothermia. This study is an essential first step to develop caffeine as a kidney protective medication in this in this vulnerable group of newborns.

NCT ID: NCT03996317 Withdrawn - Clinical trials for Respiratory Distress Syndrome, Newborn

Maternal Hyperoxygenation for Intrapartum Fetal Heart Rate Tracing Abnormalities

Start date: June 2021
Phase: N/A
Study type: Interventional

Hyperoxygenation for resuscitation of abnormal fetal heart rate tracings has been routine obstetric practice. However, there have not been any studies to support this practice. Recent literature have either found no associated benefit to intrapartum maternal oxygen administration, or in a number of studies demonstrated higher risk of neonatal complications. Despite these studies, the evidences have not been adequate to change the clinical practice because the majority of these studies either focused on biological differences rather than clinical outcomes data or were retrospective rather than randomized trials. Therefore, the investigators propose a large single center randomized clinical trial to determine the effects of maternal hyperoxygenation therapy for the treatment of fetal heart rate tracing abnormalities.

NCT ID: NCT03681314 Withdrawn - Clinical trials for Hypoxic-Ischemic Encephalopathy

Umbilical Cord Milking in Neonates Who Are Depressed at Birth-Developmental Follow Up (MIDAB-FU)

MIDAB-FU
Start date: October 17, 2022
Phase: N/A
Study type: Interventional

An extension of the MIDAB trial, the MIDAB-Follow-up trial will evaluate the neurodevelopmental outcomes at 22-26 months age of term/late preterm infants who were depressed at birth and received umbilical cord milking (UCM) or immediate cord clamping (ICC).

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: 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: NCT02551003 Withdrawn - Cerebral Infarction Clinical Trials

Neuroprotective Effect of Autologous Cord Blood Combined With Therapeutic Hypothermia Following Neonatal Encephalopathy

Start date: September 8, 2015
Phase: Phase 1/Phase 2
Study type: Interventional

This study examines the effect of cord blood in the treatment of newborn infants with neonatal encephalopathy in combination with hypothermia, which is the standard treatment for this condition. The hypothesis is that the cord blood + hypothermia combination will produce better neuroprotection than the standard treatment of hypothermia alone.

NCT ID: NCT02434965 Withdrawn - Clinical trials for Severe Hypoxic-ischemic Encephalopathy

Autologous Cord Blood and Human Placental Derived Stem Cells in Neonates With Severe Hypoxic-Ischemic Encephalopathy

HPDSC+HIE
Start date: December 2019
Phase: Phase 2
Study type: Interventional

The purpose of this study is to investigate the safety and effectiveness of autologous human placental-derived stem cells (HPDSC) in combination with autologous cord blood in neonates with severe hypoxic-ischemic encephalopathy.

NCT ID: NCT01904786 Withdrawn - Clinical trials for Newborn Hypoxic Ischemic Encephalopathy

Melatonin Treatment for Newborn Infants With Moderate to Severe Hypoxic Ischemic Encephalopathy

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

During the birth process certain conditions can cause oxygen delivery and/or blood flow to the baby's brain to become interrupted. This can cause permanent brain damage. Brain damage occurs in two phases. The first occurs at the time of injury when brain cells in the affected area 'die'. There is nothing that can be done about this. The second phase of injury occurs over the next few days. This second phase is caused by inflammation and release of toxic chemicals from the injured site. Cooling the baby to a temperature of 92.5° F, for 3 days has been shown to reduce the second phase of injury and bran death. All babies will receive the benefit of cooling. Although cooling helps it does not completely stop the second phase of injury. Melatonin is a naturally occurring hormone that is produced by the brain, and helps regulate the sleep-wake cycle. It has the potential to stop the second phase of brain injury by inhibiting inflammation and release of toxic chemicals. The reason for this research is to find out if melatonin can or cannot improve the outcome of babies with this kind of brain damage. Every baby enrolled in the study has a 50:50 chance of getting melatonin. A total of six doses of medicine will be given. The baby's brain function will be assessed by an EEG, brain oxygen monitoring, and a neurologic examination at 18 months of life. All of these are routinely used as part of standard care for patients with this kind of problem. The only difference is that half the babies enrolled in the study will get the drug called melatonin and the other half will receive placebo. The dose of melatonin being used in the study is higher than the amount normally produced by the body. No side-effects of this dose have been reported in other research studies using melatonin in newborn and premature babies.

NCT ID: NCT01128673 Withdrawn - Clinical trials for Hypoxic Ischemic Encephalopathy

MRI Thermal Imaging of Infants Undergoing Cooling for Hypoxic Ischemic Encephalopathy(HIE)

Start date: May 2010
Phase: N/A
Study type: Observational

Hundreds of babies in the world are being treated with brain cooling to prevent brain injury after they lose oxygen at birth. This study will use the newly developed information from the magnet resonance image to determine the actual temperature of the brain. This will enable us to determine if the brain is being uniformly cooled and if techniques that provide cooling need to be changed to improve the injury prevention from cooling.