Anesthesia Exposure and Neurodevelopment in Infants and Children: Pediatric Anesthesia & NeuroDevelopment (PANDA) Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 369
- 试验地点
- 4
- 主要终点
- Change in neurocognitive function
研究概览
简要总结
The purpose of this study is to determine whether the use of anesthetic agents in infants and children have long term adverse effects on neurocognitive development. According to the National Hospital Discharge Survey, around 2.5 million children have surgical procedures requiring anesthesia each year in the US. Recent animal studies have suggested that the exposure of the immature organism to a variety of commonly used anesthetic agents may lead to neurobehavioral functional deficits in vivo and to neuronal apoptosis in vitro. While the relevance of these findings on children exposed to anesthetics remains to be determined, it is clearly critically important to public health that this issue is resolved quickly and clearly.
Hypothesis: Exposure to anesthetic agents within the first three years of life will not significantly impair cognitive functions at ages 8 yr, 0 mo to 15 yr, 0 mo.
详细描述
The purpose of our study is to compare neurocognitive functions in sibling pairs: one of whom had exposure to anesthesia during surgery before 36 months of age (exposed sibling cohorts) and who would be from ages 8yr, 0 mo to15 yr, 0 mo at the time of the study; and the other who never had anesthesia or surgery less than 36 months of age, is from ages 8yr, 0mo to 15 yr, 0 mo at the time of the study, and is within 36 months of age range from the exposed sibling(unexposed sibling cohort).
Neuropsychological assessments are administered to the sibling cohorts prospectively and parents of the siblings will complete parental interviews/questionnaires. We assess individually neurocognitive, behavioral and emotional function for both exposed and unexposed siblings. Family function will also be evaluated. We will also obtain complete medical history for each participant, including significant perinatal events and social history. We also review medical records when appropriate.
All testing are performed during a one day site visit.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 年龄范围
- 8 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Exposed cohort:
- •Subjects who had inguinal hernia surgery before 36 months of age
- •Ages 8 yr, 0 mo to 15 yr, 0 mo
- •Gestation age greater or equal to 36 weeks
- •Categorized as ASA I or ASA II
- •English speaking
- •Biologically related to the unexposed sibling
- •Unexposed cohort:
- •Sibling within 36 months of age of the exposed cohort
- •Never had surgery or exposure to anesthesia prior to 36 months of age
- •Ages 8 yr, 0 mo to 15 yr, 0 mo
- •Gestation age greater or equal to 36 weeks
- •Categorized as ASA I or ASA II
- •English speaking
- •Biologically related to the exposed sibling
- •Exclusion criteria:
- •Exposed cohort:
- •Gestational age less than 36 weeks at birth
- •No exposure to surgery or anesthesia prior to 36 months of age
- •Surgery/Anesthesia other than index hernia repair prior to 36 months of age
- •Not categorized as ASA I or ASA II
- •Not ages 8 yr, 0 mo to 15 yr, 0 mo
- •Not English speaking
- •Not biologically related to the unexposed sibling
- •Unexposed cohort:
- •Gestational age under 36 weeks at birth
- •Any exposure to surgery or anesthesia prior to 36 months of age
- •Not categorized as ASA I or ASA II
- •Not ages 8 yr, 0 mo to 15 yr, 0 mo
- •Not English speaking
- •Not biologically related to the unexposed sibling
排除标准
- 未提供
结局指标
主要结局
Change in neurocognitive function
时间窗: Varies; when the participant is 8-15 years of age
Global cognitive function: verbal, performance and full IQ assessed by Wechsler Abbreviated Scale of Intelligence (WASI). These are one unit of measure for IQ.
次要结局
- Change in domain-specific function related to visual memory and learning(Varies; when the participant is 8-15 years of age)
- Change in domain-specific function related to working memory(Varies; when the participant is 8-15 years of age)
- Change in domain-specific function related to cognitive flexibility aspects of executive function(Varies; when the participant is 8-15 years of age)
- Changes in adaptive behavior(Varies; when the participant is 8-15 years of age)
- Change in domain-specific function related to receptive language(Varies; when the participant is 8-15 years of age)
- Changes in parental relationships(Varies; when the participant is 8-15 years of age)
- Change in domain-specific function related to motor and processing speed(Varies; when the participant is 8-15 years of age)
- Change in domain-specific function related to verbal memory and learning(Varies; when the participant is 8-15 years of age)
- Changes in behavior(Varies; when the participant is 8-15 years of age)
- Change in domain-specific function related to expressive language(Varies; when the participant is 8-15 years of age)
- Change in domain-specific function related to all executive function components(Varies; when the participant is 8-15 years of age)
- Change in domain-specific function related to selective attention and impulsivity(Varies; when the participant is 8-15 years of age)
研究者
Lena S. Sun
Emanuel M. Papper Professor of Anesthesiology and Professor of Pediatrics
Columbia University