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: 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
• 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

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.

项目总结

项目成果

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