Neonatal Seizure Registry Developmental Functional EValuation (NSR-DEV)

新生儿癫痫登记发育功能评估 (NSR-DEV)

基本信息

批准号：
10550229
负责人：
Hannah Cranley Glass
金额：
$ 103.58万
依托单位：
UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
依托单位国家：
美国
项目类别：
财政年份：
2020
资助国家：
美国
起止时间：
2020-03-15 至 2025-02-28
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10550229
关键词：
5 year old Acute Adaptive Behaviors Address Age Anticonvulsants Antiepileptogenic Behavior Biological Brain Brain Injuries Caring Cerebral Palsy Child Child Development Child Rearing Childhood Clinical Cognition Communication Data Development Developmental Disabilities Diagnosis Early identification Education Electroencephalography Eligibility Determination Enrollment Epilepsy Etiology Evaluation Evaluation Studies Family Funding Future Gestational Age Goals Health Impairment Infant Infrastructure Intellectual functioning disability Intelligence Intervention Intervention Studies Investigation Knowledge Lead Longterm Follow-up Measures Medical Mental disorders Mission Modeling Natural History Neonatal Nervous System Neurodevelopmental Disability Neuroprotective Agents Nursery Schools Observational Study Outcome Parents Pattern Pediatric Neurology Personal Satisfaction Persons Prognosis 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 clinical predictors clinically relevant cohort depressive symptoms design disability disability risk early childhood executive function high risk high risk population improved infancy innovation intervention program magnetic resonance imaging/electroencephalography method development model building modifiable risk neonatal seizure neonate nervous system disorder neurodevelopment neuroregulation novel patient population post-traumatic stress recruit resilience risk prediction model skills

项目摘要

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神经发育障碍。虽然幼儿期的预后是父母的关键问题提供者和提供者，超出婴儿期的结果在很大程度上是未知的。此外，有新生儿的婴儿父母癫痫发作有患心理健康障碍的风险，这可能会破坏他们照顾孩子的能力医疗复杂性，可能导致儿童发展受损。拟议的“新生儿癫痫发作注册表 - 发展功能评估（NSR-DEV）”研究将检验中心假设，即风险可以在婴儿期确定发育障碍的因素，并通过父母的福祉来改变。这项观察性研究将利用9个中心新生儿癫痫注册中心的基础设施，我们向此介绍招募了300名急性症状新生儿癫痫发作的儿童（NCT02789176）。支持当前的提案，这个独特的队列将在2-7岁的年龄上获得，参加年度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， 5岁时，癫痫和脑瘫以及面对面的金标准智商测试。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：确定残疾的预测指标先前急性症状的新生儿癫痫发作的儿童； AIM 1B：检查自适应下降的风险因素先前急性症状的新生儿癫痫发作的儿童的行为； AIM 2A：确定父母是否有良好存在（经过验证的动画或抑郁症状，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残疾的风险； AIM 2B：确定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； AIM 3：在新生儿癫痫发作后为儿童残疾建立强大的风险预测模型。该创新的提案将维护美国中心的现有多中心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父母和临床医生。这项精心设计的研究将为关键提供新颖的，临床上的新答案在这个高度脆弱的患者人群中，有关长期结局的问题。结果将告知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。

项目成果

期刊论文数量（1）

专著数量（0）

科研奖励数量（0）

会议论文数量（0）

专利数量（0）

Toward Equity in Research Participation: Association of Financial Impact With In-Person Study Participation.

实现研究参与的公平：财务影响与亲自研究参与的关联。

DOI：
10.1016/j.pediatrneurol.2023.04.019
发表时间：
2023
期刊：
Pediatric neurology
影响因子：
3.8
作者：
Shellhaas,RenéeA;Lemmon,MonicaE;Gosselin,BrianN;Sturza,Julie;Franck,LindaS;Glass,HannahC;NeonatalSeizureRegistry
通讯作者：
NeonatalSeizureRegistry