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Hypoxia-Ischemia, Brain clinical trials

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NCT ID: NCT05971446 Recruiting - Clinical trials for Hypoxic-Ischemic Encephalopathy

Healthy Little Eyes

Start date: February 24, 2020
Phase:
Study type: Observational

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.

NCT ID: NCT05901688 Recruiting - Clinical trials for Hypoxic-Ischemic Encephalopathy

Umbilical Cord Abnormalities in the Prediction of Adverse Pregnancy Outcomes

ULOOP
Start date: October 3, 2023
Phase:
Study type: Observational

The objective of our study is to investigate the association of umbilical cord abnormalities with adverse pregnancy outcomes. The umbilical cord parameters that will be investigated as part of this study include the umbilical cord coiling index (UCI), umbilical cord (UC) diameter, umbilical vein (UV) diameter, UV flow velocity and the presence of nuchal cord. The UCI, UC, UV diameter & flow and presence of nuchal cord will be measured in routine unselected populations at 20-22 weeks and 35-37 weeks gestation during the study period. We will also measure the UC and UV diameter in a nested population of high-risk pregnancies attending our placental disorders clinic which have been deemed to be at risk of having adverse pregnancy outcomes. Primary objective: To investigate if prenatal assessment of UCI, UC, UV diameter & flow and presence of nuchal cord measured routinely in unselected screened populations at 20-22 weeks and 35-37 weeks' can provide an independent prediction of pregnancies that develop adverse pregnancy outcomes. Secondary objectives: To assess the correlation of UC and UV diameter measured by ultrasound scan and fetal magnetic resonance imaging in prediction of pregnancy outcome. To examine the association of these umbilical cord measurements and observations in a nested cohort of pregnancies in the high-risk placental disorders clinic.

NCT ID: NCT05851391 Recruiting - Seizures Clinical Trials

buRst-supprESsion TO Stop Refractory Status Epilepticus Post-cardiac Arrest

RESTORE
Start date: August 7, 2023
Phase: Phase 2
Study type: Interventional

RESTORE is a randomized clinical trial investigating the safety and feasibility of using EEG treatment targets (burst suppression vs. seizure suppression) for post-cardiac arrest refractory status epilepticus treatment.

NCT ID: NCT05836610 Recruiting - Hypotension Clinical Trials

Hydrocortisone Therapy Optimization During Hypothermia Treatment in Asphyxiated Neonates

UniCort
Start date: September 21, 2021
Phase: Phase 4
Study type: Interventional

This is a prospective, single center, pharmacokinetic study of intravenous hydrocortisone therapy for systemic low blood pressure during hypothermia treatment in asphyxiated newborns. Patients will be allocated to hydrocortisone supplementation while receiving conventional inotropic therapy as needed. The hypothesis is that a detailed study of hydrocortisone pharmacokinetics during therapeutic hypothermia would help to personalize steroid supplementation in asphyxiated neonates. As the overall metabolic rate decreases with lower body temperature, drug metabolism is likely to be reduced as well, and lower doses, or less frequent dosing will be sufficient to achieve the targeted steroid range and biological effects in asphyxiated neonates with relative adrenal insufficiency. Thus, the investigators are planning to measure initial, baseline serum cortisol levels and serial serum cortisol levels after hydrocortisone supplementation in cooled asphyxiated neonates.

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: NCT05787899 Recruiting - Clinical trials for Hypoxic-Ischemic Encephalopathy

Hypothermia's Effect on Hepatitis B Vaccination

Start date: May 18, 2023
Phase:
Study type: Observational

The purpose of the research is to determine if the Hepatitis B vaccine after birth provides enough protection after cooling for Hypoxic Ischemic Encephalopathy (HIE). To do this, Hepatitis B titers (blood sample) would be taken before, during, and after administering of the Hepatitis B vaccine series to measure efficacy of the vaccine.

NCT ID: NCT05778188 Recruiting - Clinical trials for Hypoxic-Ischemic Encephalopathy

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of RLS-0071 in Newborns With Moderate or Severe Hypoxic-Ischemic Encephalopathy Undergoing Therapeutic Hypothermia

STAR
Start date: July 27, 2023
Phase: Phase 2
Study type: Interventional

Hypoxic-ischemic encephalopathy (HIE) affects approximately 4,000 to 12,000 persons annually in the United States. Mortality from HIE has been reported up to 60%, with at least 25% of survivors left with significant neurocognitive disability. Despite this vital unmet medical need, no pharmacological adjunct or alternative therapy has proven beneficial in improving outcomes in neonatal HIE. RLS-0071 is a novel peptide being developed for the treatment of neonatal HIE. This study is designed to evaluate the safety and tolerability of RLS-0071 in the treatment of newborns with moderate or severe HIE.

NCT ID: NCT05767476 Recruiting - Clinical trials for Encephalopathy, Hypoxic Ischemic

Neurodevelopmental Outcome in Newborn With Hypoxic-ischemic Encephalopathy Treated With Therapeutic Hypothermia

Start date: April 28, 2021
Phase:
Study type: Observational

The goal of this observational study is to identify early signs of poor neurodevelopmental outcome by performing specific neurological, neurophysiological and neuroimaging assessments in newborns with hypoxic-ischemic encephalopathy treated with therapeutic hypothermia. The main questions it aims to answer are: - Identify patients at risk of neuromotor, cognitive and epileptic sequelae - Plan early rehabilitation programs and future trials on early neuroprotection in infant at risk of neurodevelopmental disability Participants will be involved in serial assessment: - Before and after therapeutic hypothermia and before discharge: neurological assessment, according to the modified Sarna (t) score, Thompson's score and Hammersmith Neonatal Neurological Examination (HNNE); General Movement Assessment - Amplitude integrated electroencephalogram (aEEG) within 6 hours of life, for 6 hours. - Neonatal Cranial Ultrasonography within 6 hours of life, in the third and seventh day of life. - Brain magnetic resonance imaging between 7 and 14 days. - Electroencephalogram (EEG) within 7 days. After discharge study population will perform: - EEG between 3 and 6 months. - Neurological assessment using Hammersmith Infant Neurological Examination (HINE) at 3-6-9-12 months. - General Movement Assessment at 3 months. - Neurodevelopmental assessment using the Griffiths Mental Development Scales at 24 months. - Cognitive assessment using the Wechsler Preschool and Primary Scale of Intelligence between 36 and 41 months. - Motor performance assessment using Movement ABC between 42 and 48 months.

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: NCT05687708 Completed - Clinical trials for Hypoxic-Ischemic Encephalopathy

Effect of Non-nutritive Sucking on Transition to Oral Feeding in Infants With Asphyxia

Start date: November 1, 2021
Phase: N/A
Study type: Interventional

The transition period to full oral feeding in infants with perinatal asphyxia is important in predicting long-term outcomes. The transition to independent oral feeding is accepted as a discharge criterion by the American Academy of Pediatrics, and the long transition from tube feeding to oral feeding prolongs the discharge process. Prolonged transition to oral feeding increases maternal stress as it delays gastrointestinal problems, mother-infant interaction and attachment, as well as increasing health expenditures. Due to long-term feeding tube use; Infection, leakage, delay in wound healing, trauma caused by repeated placement, as well as oral reluctance are observed. In asphyxia infants, in whom oral-motor dysfunction is common, the transition to oral feeding takes a long time and tube feeding support is required. The effect of hypothermia, which is a general therapeutic intervention that reduces the risk of mortality and morbidity in infants with asphyxia, on oral feeding has been previously studied and shown to have a positive effect. They also found that MR imaging in infants with asphyxia and the need for gastrostomy and tube feeding in those with brainstem involvement were associated. Various interventions that affect the transition to oral nutrition positively and shorten the discharge time are included in the literature. Stimulation of non-nutritive sucking (NNS) is the most frequently preferred method among these interventions. It has been shown in studies that there are no short-term negative effects of NNS stimulation with the help of a pacifier or gloved finger, and some clinical benefits such as better bottle feeding performance, acceleration of discharge and transition to oral feeding. The effect of the NNS stimulation method, which has been shown to be effective in preterm infants with large-scale randomized controlled studies, is not known exactly. The aim of this study is to examine the effect of NNS stimulation applied to oral feeding, feeding skills, weight gain and discharge in asphyxia infants receiving hypothermia treatment.