Feasibility Study for Pediatric NeuroDevelopmental Assessment Study (PANDAS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- The primary endpoint of this feasibility study is to determine if there is an adequate population of sibling pairs at CHOP to warrant participation in a future PANDAS study.
研究概览
简要总结
We have been asked to participate in the Pediatric Anesthesia NeuroDevelopmental Assessment Study (PANDAS), which is a study to compare neurocognitive functions in sibling pairs: one of whom had exposure to anesthesia during inguinal hernia surgery before three years of age (exposed) and the other who was not exposed to anesthesia or surgery in the first three years of life (unexposed). A consortium of approximately 6 hospitals is doing this feasibility study to determine if there is an adequate number of subjects for each of the two age groups before the formal study begins.
详细描述
Feasibility study to obtain information through a telephone interview with parents of eligible children Once we identify the children who were less than one year of age and those between the ages of 1 and 3 that who had inguinal hernia surgery during the years of 1999-2007, we will call the parents to determine if the index patients have siblings. If so, we would also ask if there is a sibling within 3 years of the index patient's age and if they have had no exposure to anesthetics or sedatives before their third birthday. Exclusion criteria for both index patients and siblings would include gestational age at birth of < 36 weeks, any history of hospitalization, including neonatal ICU, a history of CNS, cardiac, or pulmonary diseases requiring medical treatment, or a history of subsequent surgery or exposure of anesthetics or sedatives.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- — 至 3 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females age 0 to 1 year.
- •Inguinal hernia surgery between 1/1/1999 and 12/31/
- •Parental/guardian permission (informed consent).
排除标准
- •Gestational age < 36 weeks.
- •Any history of hospitalization, including neonatal ICU.
- •A history of CNS, cardiac, or pulmonary diseases requiring medical treatment.
- •History of subsequent surgery or exposure to anesthetics or sedatives at less than 3 years of age.
结局指标
主要结局
The primary endpoint of this feasibility study is to determine if there is an adequate population of sibling pairs at CHOP to warrant participation in a future PANDAS study.
时间窗: 6-9 months
次要结局
未报告次要终点