Neonatal Seizure Registry Developmental Functional EValuation (NSR-DEV)

项目总结 由脑损伤引起的新生儿癫痫(急性症状性癫痫)与 婴儿期的神经发育障碍。尽管儿童早期的预后对父母来说是一个关键的问题 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，这可能会削弱他们照顾患有 医疗上的复杂性，并可能导致儿童发育受损。建议的“新生儿癫痫” 注册-发育功能评估(NSR-DEV)“研究将检验风险 发育障碍的因素可以在婴儿期确定，并被父母的幸福感所改变。 这项观察性研究将利用9中心新生儿癫痫登记的基础设施，我们 招募了300名患有急性症状性新生儿癫痫的儿童(NCT02789176)。通过支持 目前的建议是，这一独特的队列将在2-7岁时提供参加年度验证父母- 已报道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5岁时用WPPSI-IV进行面对面的金标准智商测试。 采用新生儿临床、脑电和核磁共振测量，以及3个月后的脑电和父母的纵向测量 我们将建立稳健的模型来预测这一高危人群的发展结果。 我们将通过追求以下具体目标来检验我们的假设：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：目标1b：检查适应性下降的危险因素 既往有急性症状性新生儿癫痫发作的儿童的行为；目标2a：确定父母是否健康- (焦虑或抑郁症状、创伤后应激和复原力的有效测量)会改变 既往有急性症状性新生儿癫痫发作的儿童的残疾风险；目标2b：确定 父母幸福感是否会改变既往有急性症状的儿童的适应行为轨迹 新生儿癫痫；目标3：为新生儿癫痫后的儿童残疾建立可靠的风险预测模型。 这一创新计划将保持现有的多中心队列，这些队列来自美国中心，这些中心 用于诊断和调查新生儿癫痫的最新技术，并针对研究优先事项 父母和临床医生的关系。这项精心设计的研究将提供与临床相关的新答案 关于这一高度脆弱的患者群体的长期结果的问题。结果将通知 为优化父母关系而设计的神经调节性干预研究和计划的后续设计 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.