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Hypoxia-Ischemia, Brain clinical trials

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NCT ID: NCT06460480 Recruiting - Cardiac Arrest Clinical Trials

Monitoring After Cardiac Arrest: Electroencephalogram and Cerebral Oximetry in Predicting Outcome

Start date: June 15, 2024
Phase:
Study type: Observational [Patient Registry]

Because of its high incidence, it is essential to determine the neurological prognosis after cardiac arrest. However, there is not much information to guide post-cardiac arrest care. Also, dynamic monitoring of the state of the brain can help provide information about the patient's prognosis other than previously described serum biomarkers. Therefore, the researchers will monitor postcardiac arrest patients in the intensive care unit for 48 hours by electroencephalogram and cerebral oximetry and collect blood samples for serum biomarkers: neuron-specific enolase (NSE), human neurogranin (NRGN) and human trigger receptor expressed on myeloid cells (TREM-2), which are associated with neuronal damage. And investigate the relation of these data to mortality.

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: NCT06427642 Recruiting - Clinical trials for Bronchopulmonary Dysplasia

Efficacy Evaluation of UCB-MNCs in the Treatment of Refractory Neonatal Diseases

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

Hypoxic-ischemic encephalopathy (HIE), bronchopulmonary dysplasia (BPD), short bowel syndrome (SBS) are refractory in clinical treatment. Thus, how to better prevent such diseases is currently a key research topic in the international field. The use of cord blood-derived mononuclear cells may promote to save lives and improve patient outcomes.

NCT ID: NCT06394453 Recruiting - Newborn Asphyxia Clinical Trials

Is Feeding During Therapeutic Hypothermia Safe and Can Improve Outcomes in Infants With Hypoxic-ischaemic Encephalopathy

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

Therapeutic hypothermia (TH) is the standard of care for newborns with moderate to severe hypoxic-ischaemic encephalopathy (HIE) born at 35 weeks or more of gestation. Many neonatal units do not use enteral feeding during TH, in fear of increased risk of complications. Withholding enteral feedings during TH lacks supporting evidence. The aim of the study is to determine if enteral feeding during TH in patients with HIE is safe and assess its effects. Investigators will perform multicenter randomized controlled study in level III neonatal intensive care units on infants qualified for TH. Infants will be randomized into 2 groups: (1) unfed during 72 hours of TH; (2) fed group, which will start receive enteral feeding with mother milk or human donor breast milk at 10 ml/kg/day during first day of TH, 20 ml/kg/day during second day, 30 ml/kg/day during third day. The primary outcome will be (1) combined necrotizing enterocolitis or death, (2) length of hospital stay. The secondary outcomes will be (1) time to full enteral feeding, (2) late-onset sepsis, (3) Test of Infant Motor Performance scoring, (4) MRI scoring, (5) MR spectroscopy parameters.

NCT ID: NCT06370624 Active, not recruiting - Clinical trials for Encephalopathy, Hypoxic-Ischemic

PEDI-REAVASC Resonance Imaging of Infants With Hypoxic Ischemic Encephalopathy After Hypothermia Treatment.

PEDI-REAVASC
Start date: January 17, 2023
Phase: N/A
Study type: Interventional

This study is a prospective, observational, single-center study to assess the correlation between rs-fMRI measures and clinical measures of standard MRI, NIRS, EEG and clinical scores. The target population was neonates with HIE referred to MRI after hypothermia treatment, which was initiated within 6 hours of birth, continued for 72 hours and followed by a slow rewarming period of 6-12 hours. A one-year clinical and imaging follow-up is planned. As the aim of the present study is to assess the predictiveness of the outcome one year after the HIE event, no follow-up is planned.

NCT ID: NCT06344286 Completed - Clinical trials for Hypoxic-Ischemic Encephalopathy

The Effects of Minimal Enteral Nutrition on Mesenteric Blood Flow and Oxygenation in Neonates With HIE

Start date: September 1, 2020
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to evaluate the effects of minimal enteral nutrition (MEN) on mesenteric blood flow and oxygenation with Doppler USG and Near Infrared Spectroscopy (NIRS) during therapeutic hypo¬thermia (TH) in babies with hypoxic ischemic encephalopathy. The main question it aims to answer is: 1- How do the mesenteric blood flow and oxygenation get affected with MEN during TH? Participants will be either fed with MEN during TH or given placebo.

NCT ID: NCT06195345 Recruiting - Clinical trials for Hemodynamic Instability

Individual Cerebral Hemodynamic Oxygenation Relationships (ICHOR 1)

ICHOR 1
Start date: November 1, 2018
Phase:
Study type: Observational

This is an observational study in patients who require clinical anesthesia. The main purpose of this study is to understand whether there are differences in the cerebral blood flow, and oxygen metabolism affected by different types of anesthesia. Subjects who require clinical anesthesia for a clinical MRI and for whom the use of anesthetics for the exam are in clinical equipoise are asked to join the study. All eligible subjects will be asked to provide informed consent before participating in the study.

NCT ID: NCT06168071 Enrolling by invitation - Clinical trials for Hypoxia-Ischemia, Brain

Transauricular Vagus Nerve Stimulation in Children

Start date: November 15, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to learn about brain waves during transauricular vagus nerve stimulation (taVNS) in healthy children. The main questions it aims to answer are: - What is the safety, tolerability, and physiological response of taVNS in children? - Does the electroencephalogram (EEG) change during taVNS? Participants will - undergo a brief titration session where taVNS will be titrated to below perceptual threshold - receive one session of 30 minutes of taVNS - undergo clinical EEG monitoring during taVNS - Continuous cardiorespiratory monitoring via pulse oximetry and blood pressure every 5 minutes - Answer tolerability questions before, during and after 30 minute taVNS session