Neonatal Seizure Registry Developmental Functional EValuation (NSR-DEV)

新生儿癫痫登记发育功能评估 (NSR-DEV)

• 批准号: 9887172
• 负责人: Hannah Cranley Glass
• 金额: $ 131.98万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-03-15 至 2024-02-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9887172
• 关键词: 5 year old; Acute; Adaptive Behaviors; Address; Age; Antiepileptogenic; Behavior; Biological; Brain; Brain Injuries; Caring; Cerebral Palsy; Child; Child Development; Child Rearing; Childhood; Clinical; Cognition; Communication; Data; Development; Developmental Disabilities; Diagnosis; Electroencephalography; Enrollment; Epilepsy; Etiology; Evaluation; Evaluation Studies; Family; Foundations; Funding; Future; Gestational Age; Goals; Gold; Health; Impairment; Infant; Infrastructure; Intellectual functioning disability; Intelligence; Intervention; Intervention Studies; Investigation; Knowledge; Lead; Longterm Follow-up; Magnetic Resonance Imaging; Measures; Medical; Mental Depression; Mental disorders; Mission; Modeling; Natural History; Neonatal; Neurodevelopmental Disability; Neuroprotective Agents; Nursery Schools; Observational Study; Outcome; Parents; Pattern; Pediatric Neurology; Personal Satisfaction; Persons; Pharmaceutical Preparations; Provider; Public Health; Radiology Specialty; Registries; Regression Analysis; Reporting; Research; Research Design; Research Priority; Risk; Risk Factors; School-Age Population; Seizures; Severities; Targeted Research; Technology; Testing; Time; United States National Institutes of Health; Well in self; aged; anxiety symptoms; clinically relevant; cohort; design; disability; early childhood; executive function; high risk; high risk population; improved; infancy; innovation; intervention program; method development; model building; modifiable risk; neonate; nervous system disorder; neurodevelopment; neuroregulation; novel; outcome forecast; patient population; post-traumatic stress; recruit; resilience; risk prediction model; skills; stress resilience

PROJECT SUMMARY Neonatal seizures due to brain injury (acute symptomatic seizures) are associated with high risk of neurodevelopmental disability in infancy. Although prognosis in early childhood is a critical question for parents and providers, outcomes beyond infancy are largely unknown. Further, parents of infants with neonatal seizures are at risk for mental health disorders, which can undermine their ability to care for a child with medical complexity and may contribute to impaired child development. The proposed “Neonatal Seizure Registry – Developmental functional EValuation (NSR-DEV)” study will test the central hypothesis that risk factors for developmental disabilities can be identified in infancy and are modified by parent well-being. This observational study will leverage the infrastructure of the 9 center Neonatal Seizure Registry, to which we have recruited >300 children with acute symptomatic neonatal seizures (NCT02789176). With support for the current proposal, this unique cohort will be available at ages 2-7 years to participate in annual validated parent- reported developmental evaluations to characterize cognition, adaptive behavior, executive function, behavior, epilepsy and cerebral palsy, as well as in-person, gold standard IQ testing with the WPPSI-IV at age 5 years. Using neonatal clinical, EEG and MRI measures, as well as 3-month EEG, and longitudinal measures of parent well-being, we will build robust models to predict developmental outcome in this high risk population. We will test our hypotheses by pursuing the following specific aims: Aim 1a: Identify predictors of disability in children with prior acute symptomatic neonatal seizures; Aim 1b: Examine risk factors for decline in adaptive behavior in children with prior acute symptomatic neonatal seizures; Aim 2a: Determine whether parent well- being (validated measures for symptoms of anxiety or depression, post-traumatic stress, and resilience) alters the risk for disability among children with prior acute symptomatic neonatal seizures; Aim 2b: Determine whether parent well-being alters the adaptive behavior trajectory in children with prior acute symptomatic neonatal seizures; Aim 3: Build robust risk prediction models for childhood disability after neonatal seizures. This innovative proposal will maintain an existing, multicenter cohort enrolled from US centers that employ state-of-the-art technology for diagnosis and investigation of neonatal seizures, and targets research priorities of parents and clinicians. This carefully designed study will provide novel, clinically-relevant answers to key questions about long term outcomes in this highly vulnerable patient population. Results will inform the subsequent design of neuromodulatory intervention studies and programs designed to optimize parent-related factors with the goal of improving neurodevelopmental outcomes.

项目摘要 由于脑损伤引起的新生儿癫痫发作（急性症状癫痫发作）与高风险有关 婴儿期的神经发育障碍。 提供者，超出婴儿期的结果是很大程度上的。 癫痫发作有精神疾病的风险，这可能会破坏与患有儿童的照顾能力。 医疗复杂性，可能有助于儿童发展。 注册发育功能评估（NSR-DEV）”研究将检验中心假设，即风险 可以在婴儿期确定发育性的不认知因素，并通过父母的福祉来改变。 这项观察性研究将利用9个中心的新生儿癫痫发作注册表，wee 招募了300名急性症状的儿童（NCT02789176）。 当前的提案，这个独特的队列将在2-7岁的年龄上可用，以参加年度验证的经过验证的父母 - 报告的发展评估以表征认知，适应性行为，执行功能，行为， 癫痫病和大脑麻痹，以及面对面的金标准智商，其年龄为5岁。 使用新生儿临床，脑电图和MRI测量以及3个月的脑电图以及父母的纵向测量 幸福感，我们将建立强大的模型，以预测这个高风险人群中的发展结果。 我们将通过追求以下特定目的来检验我们的假设：目标1A：确定拒绝的预测指标 具有急性症状的儿童新生儿癫痫发作； 急性症状性癫痫发作的儿童的行为； 存在（经过验证的焦虑或剥夺症状，创伤后压力和韧性）改变了 先前急性症状的新生儿癫痫发作的儿童拒绝的风险； 父母的福祉是否改变了先前急性症状的儿童的适应性行为轨迹 新生儿癫痫发作；目标3：在新生儿癫痫发作后建立强大的风险预测模型。 该创新的提案将维护着雇用的美国中心的现有多件队列 用于诊断和调查新生儿癫痫发作的最先进技术，并针对研究优先事项 这项精心设计的研究将为Keyy提供新颖的临床答案 关于脆弱人群的长期结果的问题。 随后的神经调节干预研究和旨在优化父母相关的计划的设计 旨在改善神经发育结果的因素。