Neonatal Seizure Registry - Developmental Functional EValuation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 188
- 试验地点
- 9
- 主要终点
- Full scale IQ (FSIQ) score for each child on the Wechsler Preschool and Primary Scale of Intelligence, 4th Edition (WPPSI-IV)
研究概览
简要总结
The NSR-DEV study is a longitudinal cohort study of around 280 Neonatal Seizure Registry participants that aims to evaluate childhood outcomes after acute symptomatic neonatal seizures, as well as examine risk factors for developmental disabilities and whether these are modified by parent well-being.
详细描述
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 NSR-DEV study is a longitudinal cohort study of around 280 Neonatal Seizure Registry participants enrolled at one of nine sites across the USA. Participants will be evaluated using developmental questionnaires and in-person neurodevelopmental testing. Parent well-being will be assessed at each time point.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 2 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Enrolled in NSR-II
- •Alive at the start of the NSR-DEV study period
- •Parent(s) who are English or Spanish literate (with assistance of interpreter)
排除标准
- •Neonates who were found to have exclusion criteria after NSR-II enrollment
- •Risk for adverse outcome independent of seizures and underlying brain injury (including but not limited to: inborn errors of metabolism, fetal infection, brain malformation)
- •Transient cause for seizures (e.g., mild hypoglycemia, hyponatremia, hypocalcemia with normal neuroimaging)
- •Neonatal-onset epilepsy syndromes
结局指标
主要结局
Full scale IQ (FSIQ) score for each child on the Wechsler Preschool and Primary Scale of Intelligence, 4th Edition (WPPSI-IV)
时间窗: At age 5.5 years during in-person study visit
The WPPSI-IV is an in-person assessment administered by a psychologist or psychometrician that will be used to measure neurocognitive ability. Full Scale IQ (FSIQ) will be generated for each participant from the following subtests: Verbal Comprehension Index (VCI), Visual Spatial Index (VSI), Fluid Reasoning Index (FRI), Working Memory Index (WMI), Processing Speed Index (PSI), Receptive Vocabulary and Picture Naming.
次要结局
- Change in scores over time for each child on the Vineland Adaptive Behavior Scales, 3rd Edition(At enrollment study visit and annual visits when the child is age 3, 4, 5.5, 7, and 8)