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临床试验/NCT00890344
NCT00890344已完成不适用

"Body Composition Assessment in Healthy Full-term Neonates by Anthropometry, Air Displacement Plethysmography (PeaPod) and Multiple-frequency Bio-impedance Analysis (BIA)"

Nantes University Hospital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2009年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
1
主要终点
Accuracy and reproducibility of the PeaPod compared with Anthropometry and BIA. We defined that assessments are convergent if the difference between methods is less than 10 percent.

研究概览

简要总结

Low birth weight and prematurity are associated with adverse metabolic outcome in adult life. Yet it remains to be determined whether this outcome is the consequence of the low birth weight per se, or of the catch up growth achieved in Neonatology units using an early, 'aggressive' nutritional management. As a matter of fact, 'aggressive' nutrition may promote fat mass, rather than lean body mass accretion. Assessment of body composition therefore is key to evaluate the efficacy of the nutritional management of these infants. Scarce data is, however, available in the literature about the body composition of healthy full-term neonates in the first few days of life.

The aim of this study is to:

  1. Evaluate the feasibility and reproducibility of a safe and non invasive method of measurement of infant body composition by Air Displacement Plethysmography (PeaPod). Anthropometry and BIA will be used as the reference techniques to assess the accuracy of the PeaPod
  2. Describe the body composition (fat mass, fat free mass) of healthy full-term neonates in the first few weeks of life
  3. Obtain data on the total body water content of healthy full term infants from BIA.

研究设计

研究类型
Observational
时间视角
Prospective

入排标准

年龄范围
— 至 1 Day(Child)
性别
All
接受健康志愿者

入选标准

  • Full-term infants
  • 10th percentile for gestational age, according to the Audipog's growth chart

排除标准

  • Congenital diseases
  • Chromosomal abnormalities
  • Any disease requiring intensive care

结局指标

主要结局

Accuracy and reproducibility of the PeaPod compared with Anthropometry and BIA. We defined that assessments are convergent if the difference between methods is less than 10 percent.

时间窗: August 2009

次要结局

  • Describe the body composition (fat mass, fat free mass) of healthy full-term neonates To get data on the total body water that we can refer to from BIA.(August 2009)

研究者

申办方类型
Other

研究点 (1)

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