Retrospective Review of Indications and Results of Brain MRI With Anesthesia/Sedation in Children Less Than Three Years of Age
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 561
- 试验地点
- 1
- 主要终点
- Etiologic diagnosis obtained from MRI brain
研究概览
简要总结
The investigators aim to identify the frequency with which an elective brain MRI yields and etiologic diagnosis to explain its indication. The protocol includes children undergoing elective brain MRI with anesthesia prior to their third birthday.
详细描述
On December 14, 2016 the FDA issued a warning regarding elective anesthetics in children under three years of age. While a single, short exposure to general anesthesia may not have negative effects on behavior or learning, repeated or prolonged anesthetics may affect brain development. To that end, minimizing exposure to elective general anesthetics if procedures are not clearly indicated in young children appeals to reason.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- — 至 1095 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female aged 0-36 months who received anesthesia (volatile gas anesthesia) or IV sedation (propofol, dexmedetomidine, barbiturates, benzodiazepines, or other agents) for brain MRI
排除标准
- •MRI without sedation, brain MRI plus additional MRI imaging, i.e. spine, heart, etc., sedated MRI by a member of other department besides Anesthesiology.
结局指标
主要结局
Etiologic diagnosis obtained from MRI brain
时间窗: 1 year
Determine the incidence of brain MRI abnormality that led to etiological explanation of developmental delay, autism or seizure.
次要结局
- Incidence of repeat MRI(1 year)
- Quantify anesthetic exposure(1 year)
研究者
Jamie Sinton
Assistant Professor
Baylor College of Medicine