Neonatal Seizure Registry Developmental Functional EValuation (NSR-DEV)

项目摘要 由于脑损伤引起的新生儿癫痫发作（急性症状性癫痫发作）与以下高风险相关： 神经发育障碍虽然儿童早期的预后对父母来说是一个关键问题， 和提供者，婴儿期以后的结果在很大程度上是未知的。此外，新生儿的父母 癫痫发作有精神健康障碍的风险，这可能会破坏他们照顾患有癫痫的孩子的能力。 医学上的复杂性，并可能导致儿童发育受损。拟议的"新生儿癫痫" 登记研究-发育功能评估（NSR-DEV）"研究将检验中心假设，即风险 发育障碍的因素可以在婴儿期确定，并通过父母的福祉进行调整。 这项观察性研究将利用9个中心的新生儿癫痫登记处的基础设施， 招募了> 300名患有急性症状性新生儿癫痫发作的儿童（NCT 02789176）。通过支持 目前的提议，这个独特的队列将在2 - 7岁时参加年度验证的父母- 报告的发展评估，以表征认知，适应行为，执行功能，行为， 癫痫和脑瘫，以及在人，金标准智商测试与WPPSI-IV在5岁。 使用新生儿临床、EEG和MRI测量，以及3个月EEG和父母纵向测量 我们将建立强大的模型来预测这一高风险人群的发展结果。 我们将通过追求以下具体目标来测试我们的假设：目标1a：确定残疾的预测因素， 既往有急性症状性新生儿癫痫发作的儿童;目的1b：检查适应性下降的危险因素 有早期急性症状性新生儿癫痫发作的儿童的行为;目的2a：确定父母是否健康- 存在（焦虑或抑郁症状、创伤后压力和恢复力的有效测量）改变 有早期急性症状性新生儿癫痫发作的儿童残疾风险;目标2b：确定 父母的幸福感是否会改变有急性症状儿童的适应行为轨迹 新生儿癫痫发作;目标3：建立新生儿癫痫发作后儿童残疾的可靠风险预测模型。 这项创新提案将维持现有的多中心队列，这些队列从美国中心招募， 用于诊断和调查新生儿癫痫发作的最先进技术，并针对研究重点 家长和临床医生。这项精心设计的研究将提供新颖的，临床相关的答案， 关于这一高度脆弱患者人群的长期结局的问题。结果将通知 随后设计神经调节干预研究和计划，旨在优化父母相关的 以改善神经发育结果为目标的因素。

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.