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Hypoxia-Ischemia, Brain clinical trials

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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

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: NCT06090968 Recruiting - Clinical trials for Hypoxic-Ischemic Encephalopathy

Umbilical Cord Milking Versus Immediate Cord Clamping in Full Term Neonates (≥ 37 Weeks) Requiring Resuscitation

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

The objective of the study is to compare the incidence of Hypoxic ischemic encephalopathy (all stages) among singleton term neonates (≥ 37 weeks) requiring resuscitation who will undergo Umbilical cord milking as compared to Immediate cord clamping.

NCT ID: NCT06081283 Recruiting - Stroke Clinical Trials

Antiseizure Medication in Seizure Networks at Early Acute Brain Injury

Start date: November 20, 2023
Phase: Phase 4
Study type: Interventional

The goal of this clinical trial is to explore the effect of FDA-approved antiseizure drugs in the brain connectivity patterns of severe and moderate acute brain injury patients with suppression of consciousness. The main questions it aims to answer are: - Does the antiseizure medication reduce the functional connectivity of seizure networks, as identified by resting state functional MRI (rs-fMRI), within this specific target population? - What is the prevalence of seizure networks in patients from the target population, both with EEG suggestive and not suggestive of epileptogenic activity? Participants will have a rs-fMRI and those with seizure networks will receive treatment with two antiseizure medications and a post-treatment rs-fMRI. Researchers will compare the pretreatment and post-treatment rs-fMRIs to see if there are changes in the participant's functional connectivity including seizure networks and typical resting state networks.

NCT ID: NCT06048796 Recruiting - Heart Arrest Clinical Trials

Early Cessation of Sedation and TTM in Patients With a Favourable EEG After Cardiac Arrest

SELECT
Start date: March 12, 2024
Phase: N/A
Study type: Interventional

The objective of this study is to estimate the feasibility and safety of early weaning from ICU treatment in patients after cardiac arrest and an early (< 12 h) favourable EEG pattern (indicating no or mild postanoxic encephalopathy).