Use of Bedside Ultrasound to Monitor Body Composition and Neurodevelopmental Outcomes in Formerly-Premature Toddlers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Ultrasound Measurements
研究概览
简要总结
The overall objective of the proposal is to evaluate the ability of ultrasound to predict the body composition of toddlers in the outpatient clinical setting and to evaluate the relationship between body composition and neurodevelopment.
详细描述
The investigators will address the hypothesis in the following Specific Aims:
Specific Aim 1: Validate ultrasound as a method to measure whole body fat mass and fat-free mass in toddlers. Body composition will be assessed using ultrasound measurements and the validated method of air displacement plethysmography (ADP).
Specific Aim 2: Determine the effect of a handheld Force-Measuring Ultrasound Probe on intra- and inter-observer variability in ultrasound measurements. A device which measures the force applied to the ultrasound probe will be used to obtain measurements of muscle and adipose tissue thickness (biceps, abdomen, and quadriceps) in toddlers.
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
- 2 Years 至 4 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •toddlers who were ≤ 36 weeks gestational age (GA) at birth who attend the University of Minnesota Masonic Children's Hospital NICU Follow Up Clinic
- •written consent obtained from a parent before or at time of visit
排除标准
- •toddlers who require medical support that prevents them from having ADP measurements taken
- •those with an inability to sit in a supported seat for 5 minutes
- •those weighing less than 10 kg
结局指标
主要结局
Ultrasound Measurements
时间窗: through study completion, up to 2 years
Tissue thickness (adipose and muscle) will be measured in cm using the ultrasound probe.
次要结局
- Body Composition Measurements(through study completion, up to 2 years)
- Neurodevelopmental Status for 3 and 4 year olds(through study completion, up to 2 years)
- Neurodevelopmental Status for 2 year olds(through study completion, up to 2 years)