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Hypoxia-Ischemia, Brain clinical trials

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NCT ID: NCT06448780 Not yet recruiting - Clinical trials for Hypoxic-Ischemic Encephalopathy

Dose Optimization of Caffeine for HIE

Start date: November 2024
Phase: Phase 1
Study type: Interventional

This is a phase Ib, open-label, dose-validating and safety study of caffeine in neonates with hypoxic-ischemic encephalopathy (HIE) undergoing therapeutic hypothermia.

NCT ID: NCT06447155 Not yet recruiting - Feeding Patterns Clinical Trials

Continuous Versus Bolus Feeding in Neonates With Hypoxic Ischemic Encephalopathy

Start date: June 15, 2024
Phase: N/A
Study type: Interventional

Therapeutic hypothermia (TH) is accepted worldwide as a standard of care for infants born at or beyond 36 weeks gestational age with moderate-to-severe hypoxic ischaemic encephalopathy (HIE). While central nervous system is the most affected organ system , multiorgan dysfunction including renal, pulmonary, cardiac, and/or gastrointestinal (GI) compromise is not infrequent. Although the process of 'cooling' itself is well defined, based on high-quality randomized controlled trials, there are few data to inform the provision of nutrition to infants with HIE during and soon after TH.However, breastfeeding plays a beneficial role in maintaining the structural and functional integrity of the gut. It may help to reduce systemic inflammatory response and positively regulates the microbiota. In many studies it is stated that enteral feeding during TH appears to be safe and feasible. There is insufficient evidence to choose the type of enteral feeding either bolus or continuous during TH. The present study aimed to compare the impact of different types of enteral feeding in infants with HIE receiving TH.

NCT ID: NCT06429007 Not yet recruiting - Infant Development Clinical Trials

A Safety and Feasibility Trial Protocol of Metformin in Infants After Perinatal Brain Injury

Start date: October 1, 2024
Phase: Phase 2
Study type: Interventional

Infants with hypoxic-ischemic encephalopathy (HIE) are at high risk for neurodevelopmental impairment, despite current standards of care. Adjunctive treatments to promote brain repair are needed. The antidiabetic drug metformin has recently been recognized as a neurorestorative agent, but, to date, has not been used in infants. Herein, the investigator describes a clinical trial with the aim of demonstrating the safety and feasibility of metformin use to improve neurodevelopmental outcomes in infants with HIE.

NCT ID: NCT06145256 Not yet recruiting - Clinical trials for Hypoxic Ischemic Encephalopathy

Radiological Evaluation of Hypoxic Ischemic Encephalopathy

Start date: December 10, 2023
Phase:
Study type: Observational

To compare between Transcranial Ultrasound , MRI and CT in patients with Hypoxic Ischemic Encephalopathyas regards diagnostic accuracy and prognostic value .

NCT ID: NCT06139250 Not yet recruiting - Clinical trials for Hypoxia-Ischemia, Brain

Development of a High-speed Multimodal Photoacoustic/Ultrasound System for Functional Imaging of the Neonatal Brain

Start date: January 1, 2024
Phase:
Study type: Observational

In today's medical field, there is a growing emphasis on the development of functional and molecular imaging. Therefore, it has significant technical limitations. To address this issue, this project aims to develop a high-speed multimodal photoacoustic/ultrasound functional imaging system that provides both structural and functional information of tissue and organs, thus enhancing the accuracy of early screening and diagnosis of neonatal cranial lesions. This imaging technology is entirely non-invasive and does not involve ionizing radiation or contrast agents. Products using the same technology have already received FDA approval and entered clinical use in the United States. We develop a new generation of multimodal photoacoustic/ultrasound functional imaging equipment to reveal the physiological characteristics and structural details of neonatal cranial lesions, offering advantages and complementary information compared to traditional medical imaging methods.

NCT ID: NCT05820178 Not yet recruiting - Stroke Clinical Trials

tDCS and rTMS in Patients With Early Disorders of Consciousness

Start date: May 1, 2023
Phase: N/A
Study type: Interventional

A randomized controlled study was conducted to explore the efficacy of early transcranial direct current stimulation (tDCS) and repetitive transcranial magnetic stimulation (rTMS) to promote wakefulness in patients with disorder of consciousness (DOC). In order to improve the prognosis of DOC patients with nontraumatic brain injury, we compared the effects of tDCS and rTMS on clinical behavior and neurophysiological performance, and selected a wake-up technique that could improve the prognosis of DOC patients with nontraumatic brain injury as early as possible, so as to reduce the pain of patients and their loved ones, and to reduce the economic burden of society and families.

NCT ID: NCT05749458 Not yet recruiting - Clinical trials for Hypoxic Ischemic Encephalopathy of Newborn

Maternal and Neonatal Risk Factors of HIE

Start date: November 1, 2023
Phase:
Study type: Observational

The current work aims to: The primary aim in this study was to identify the contribution of maternal, pregnancy, birth and neonatal factors to encephalopathic features in new born infants. The secondary aim of this study is to reduce the burden on the country by decreasing the rate of neonatal encephalopathy, decreasing the different grades of neurodevelopmental impairment and improvement the quality of life.

NCT ID: NCT05648812 Not yet recruiting - Clinical trials for Neonatal Hypoxic Ischemic Encephalopathy

Neonatal Brain Ultrasound With CEUS and Elastography

Start date: May 2023
Phase: Phase 3
Study type: Interventional

The aim of our study is to investigate changes of brain perfusion and elasticity in neonates during the time that a neonate is adapting to live outside the womb and during diseases that are suspected to affect neonatal brain perfusion. We use contrast enhanced ultrasound (sulphur hexafluoride) and ultrasound-assisted elastography to evaluate the state of brain perfusion. We will study neonates recruited from the Neonatal Units of Turku University Hospital.

NCT ID: NCT05514665 Not yet recruiting - Clinical trials for Hypoxic-Ischemic Encephalopathy

Functional Imaging of Baby Brains

FIBB
Start date: March 2024
Phase:
Study type: Observational

Infants are at risk of developing motor and cognitive neurodevelopmental disabilities as a sequelae to hypoxic-ischemic brain injury during the perinatal period. It is an ongoing challenge to predict the severity and extent of future developmental impairment during the neonatal period. This study will help test the feasibility of conducting a large-scale study that evaluates the role of diffuse optical tomography as a bedside neuroimaging tool in complementing the prognostic value of conventional and diffusion weighted MRI for predicting neurodevelopmental outcome in neonates with perinatal hypoxic-ischemic brain injury.

NCT ID: NCT05490173 Not yet recruiting - Premature Birth Clinical Trials

The Pilot Experimental Study of the Neuroprotective Effects of Exosomes in Extremely Low Birth Weight Infants

Start date: October 5, 2022
Phase: N/A
Study type: Interventional

To study the safety and efficacy of intranasal administration of exosomes derived from mesenchymal stromal cells on long-term neurodevelopmental outcome in extremely low birth weight infants born at gestational age 25/0-27/6 weeks.