A Prospective, Observational, Multicenter Study on Ultrasound Evaluation of Superior Mesenteric Artery Measurements in a Healthy Pediatric Population
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 289
- 试验地点
- 2
- 主要终点
- Define the normal range of values of the SMA angle
研究概览
简要总结
Multicenter, prospective, observational research project on children aged from 10 to 15 years old undergoing abdominal ultrasound examinations during routine clinical practice.
详细描述
Demographics data, clinical indications, ultrasound diagnosis, and ultrasound measurements will be recorded and stored on an database. Ultrasound measurements will be analyzed to define the normal range of values of Superior Mesenteric Artery (SMA) angle and Superior Mesenteric Artery - Aorta (SMA-A) distance in the pediatric population according to age, Body Mass Index (BMI), and fat parameters.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 10 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female children
- •Age ranging from10 to 15 years, included
- •Abdominal ultrasound examination to be performed for indications other than gastrointestinal evaluation
- •Signed Informed Consent
排除标准
- •Presence of a disease that could distort the anatomy around the SMA (e.g., abdominal mass, lymphadenopathy, severe scoliosis, free abdominal fluid)
- •Oncologic patients at risk of neoplastic cachexia.
结局指标
主要结局
Define the normal range of values of the SMA angle
时间窗: 1 day
Measurement in degree with its 95% confidence interval
次要结局
- Define the normal range of values of the SMA-A distance D(1 day)
- Assess the association between the SMA angle and BMI categories(1 day)
- Define the normal range of values of the SMA-A distance LV(1 day)
- Define the normal range of values of the SMA angle (degree), SMA-A distance LV(1 day)
研究者
Marirosa Cristallo Lacalamita
MD Principal investigator
Ente Ospedaliero Cantonale, Bellinzona