跳至主要内容
临床试验/NCT03241082
NCT03241082进行中(未招募)不适用

Use of Bedside Ultrasound to Assess Neonatal Body Composition in the Neonatal Intensive Care Unit

University of Minnesota1 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2017年10月23日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
68
试验地点
1
主要终点
Whole-body measurements of body composition

研究概览

简要总结

The overall objective of the proposal is to evaluate the ability of ultrasound to predict and routinely (weekly) monitor changes in the body composition of healthy preterm infants in the neonatal intensive care unit (NICU) in response to nutritional intake. The investigators hypothesize that ultrasound is an accurate method to routinely monitor the quality of weight gain and assess the adequacy of nutritional provision for premature infants in the neonatal intensive care unit.

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 healthy, premature infants. Body composition will be assessed using ultrasound measurements and the validated method of air displacement plethysmography (ADP). Stable isotope dilution techniques will be used in a subset of our population as a secondary source of validation.

Specific Aim 2: Determine whether ultrasound measurements can detect clinically relevant (weekly) changes in body composition in healthy premature infants. Ultrasound will be used to obtain serial (weekly) measurements of muscle and adipose tissue thickness (triceps, abdomen, quadriceps) until discharge in healthy, premature infants.

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
25 Weeks 至 34 Weeks(Child)
性别
All
接受健康志愿者

入选标准

  • Healthy, premature infants 25-34+6 weeks gestational age at birth
  • Admitted to the University of Minnesota Masonic Children's Hospital NICU
  • Stable on room air or can be removed from respiratory support for 5 minutes
  • Written or verbal (telephone) informed consent can be secured from a parent within 1 week of admission to the NICU

排除标准

  • Require medical support preventing ADP measurements

结局指标

主要结局

Whole-body measurements of body composition

时间窗: Up to 6 weeks

Measurement of whole body fat mass and fat-free mass via air displacement plethysmography and stable isotope dilution.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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