View clinical trials related to Neonatal Encephalopathy.
Filter by:The goal of this single-centre longitudinal observational study is to create reference values for diastolic function parameters in neonates born at 35 weeks' gestation or above, and to assess the influence of pre-defined antenatal, intrapartum, maternal, and neonatal factors on cardiac function. The main question it aims to answer are: - What are the normal reference ranges for parameters of diastolic cardiac function in neonates? - How are these influenced by maternal, intrapartum and neonatal factors? - Do the diastolic changes noted during the first two days of life persist into infancy? Participants will have four echocardiographic assessments in total: - Two during the first 48 hours of life (prior to discharge home) - Two during infancy (as an outpatient)
Around the time of birth, some babies experience a condition called asphyxia, which means that their brain and other organs do not receive enough blood and/or oxygen to work properly. This life-threatening condition accounts for nearly 1 out of 4 deaths of all babies around the world, and often leads to severe brain damage, cerebral palsy, epilepsy, and trouble with learning and functioning in everyday life. At this time, no treatment is available to repair the brain damage caused by asphyxia. Excitingly, a drug called sildenafil (Viagra®) is already given safely to babies who suffer from increased blood pressure in their lungs' vessels. Recent studies using a laboratory model of asphyxia at birth suggest that sildenafil may also repair the brain damage caused by asphyxia. Similarly, recent small studies have shown that it is both feasible and safe to give sildenafil to human babies, who suffered from asphyxia at birth. These studies also highlight the first promising signs that sildenafil may improve how the brains of these babies work, which is consistent with the abovementioned laboratory studies. On the basis of these previous researches, the investigators predict that sildenafil can repair the damage to a baby's brain. The investigators will test whether sildenafil can be safely given to a large group of human babies who suffer from asphyxia at birth, and will confirm whether sildenafil improves or not how their brains and hearts/lungs work. This project will enable to determine whether sildenafil is a promising treatment for repairing brain damage in babies who suffer from asphyxia at birth. This project may also provide new solutions for these babies to improve their future life.
The purpose of this research study is to gather more information on how eye injury is related to a baby's future development and see if eye function and brain test results can be used, along with current measures, to better diagnose and treat babies with hypoxic-ischemic encephalopathy (HIE). Participants will undergo up to two eye exam sessions, involving both Visual Evoked Potential (VEP) and Electroretinogram (ERG) exams.
In this study, the objective is to compare neonatal cerebral oxygenation and electrical activity within 3 days after birth across different altitude areas using non-invasive methods, specifically near infrared spectroscopy (NIRS) and amplitude-integrated electroencephalography (aEEG), and establish reference value for each altitude level.
The goal of this randomised control trial is to establish the safety and efficacy of whole-body hypothermia for babies with mild hypoxic ischaemic encephalopathy, inform national and international guidelines, and establish uniform practice across the NHS. The main questions it aims to answer are: 1. Does whole-body cooling (33.5+0.5°C) initiated within six hours of birth and continued for 72 hours, improve cognitive development at 24 (±2) months of age after mild neonatal encephalopathy compared with normothermia (37+0.5°C)? 2. Does a prospective trial-based economic evaluation support the provision of cooling therapy for mild encephalopathy in the NHS on cost-effectiveness grounds? Participants will have the following interventions: - Randomisation into one of the following groups - Whole body hypothermia group - Targeted normothermia group - Bayley Scales of Infant and Toddler Development 4th Edition (Bayley-IV) examination at 24 (±2) months of age. Researchers will compare the mean Cognitive Composite Scale score from the Bayley IV examination between the two groups.
This study uses medical records that allow retrospective data extraction of clinical manifestation to assess the natural history of HPDL mutations
The study aims to establish the diagnostic vcalue of a structured neurological examination to detect eraly neurological abnormlaities in infants at risk of neurological abnormlaiyies.
The goal of this study is to characterize the ability and related brain profiles of children with Neonatal encephalopathy (NE) - Therapeutic hypothermia (TH) at 9 years old. The main questions it aims to answer are: 1. Compare executive function, attention, social cognition, behaviour, anxiety, self-esteem, and peer problems between children with NE-TH and matched peers without NE. 2. Compare brain volumes, cortical and subcortical morphology, white matter microstructure, and myelination between children with NE-TH and matched peers without NE. 3. Evaluate the associations of perinatal risk factors and structural brain integrity with neuropsychological deficits to inform about the potential aggravating and protective factors for neuropsychological functioning. Participants will complete one study visit to perform standardized evaluations and a brain MRI. Parents of participants will be invited to complete a series of questionnaires during this study visit or at a moment of their choice virtually.
Studying the effect of passive versus Blanket roll III modality of therapeutic hypothermia (TH)on myocardial function of asphyxiated neonates through using tissue Doppler (TD).
The main purpose of this study is to determine the maximum safe tolerated dose of LEV in the treatment of neonatal seizures. Our hypothesis is that optimal dosing of Levetiracetam (LEV) to treat neonatal seizures is significantly greater than 60mg/kg. This study will be an open label dose-escalation, preliminary safety and efficacy study. There will be a randomized control treatment component. Infants recognized as having neonatal seizures or as being at risk of developing seizures will be recruited and started on continuous video EEG monitoring (CEEG). Eligibility will be confirmed and consent will be obtained. In the first 2 phases of the study, neurologists will identify neonates with mild-moderate seizure burden (less than 8 minutes cumulative seizure activity per hour), appropriate for study with LEV, and exclude patients with higher seizure burden where treatment with PHB is more appropriate. Phase 3 of the dose escalation will only proceed if additional efficacy of LEV has been demonstrated in phases 1 and 2. In Phase 3 we will recruit neonates with seizures of greater severity up to 30 minute seizure burden/hour. This will make the final results of study more generalizable. If seizures are confirmed, enrolled subjects will receive 60mg/kg of LEV. Subjects whose seizures persist or recur 15 minutes after the first infusion is complete, subjects will then be randomized in the dose escalation study. Patients in the dose escalation study will be randomly assigned to receive either higher dose LEV or treatment with the control drug PHB in a 3:1 allocation ratio, stratified by site. Funding Source- FDA OOPD