Incidence of Neurocognitive Deficits in Patients After Treatment for Retinoblastoma With Multiple Anesthesia Exposures
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Comparing scores in neuropsychological testing results
研究概览
简要总结
The purpose of this study is to see if there is a difference between the development of the brain (neurodevelopment) in children who have been treated for retinoblastoma with multiple anesthetic exposures, compared with brain development in children who have never had anesthesia.
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
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 6 and < 17 years old
排除标准
- •Diagnosis of any secondary disease associated with developmental delay
- •History of second cancer diagnosis
- •Legal Blindness
- •Past surgery of any type, with the exception of enucleation for retinoblastoma
- •Past exposure to anesthesia for surgical intervention
- •More than one anesthesia encounter for surgical intervention before diagnosis at MSK
- •Past External Beam Radiation for treatment of retinoblastoma
- •Past systemic chemotherapy
- •Non-native speaker of English; however, children whose parents speak only Spanish will be included, because the tests for parents are available in Spanish
结局指标
主要结局
Comparing scores in neuropsychological testing results
时间窗: 6 weeks
The primary outcome is based on the Wechsler Intelligence Scale for Children, 5th edition (WISC-V) measured at follow up. The 5 primary index scores on the WISC-V (Verbal Comprehension, Visual Spatial, Fluid Reasoning, Working Memory, and Processing Speed) are based on 10 subtests and represent intellectual functioning in different cognitive areas. Similar to the FSIQ, the primary index scores are on a standard score metric with a mean of 100 (SD=15). The WISC-V consists of 16 subtests; each subtest is based on a scaled score metric with a mean of 10 and standard deviation (SD) of 3. Performance on these domain-specific subtests will be summarized and analyzed similarly to the FSIQ.
次要结局
未报告次要终点