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临床试验/NCT03572504
NCT03572504已完成不适用

Comparison to World Health Organization (WHO) Gold Standard of Extrapolation and Estimation Methods to Assess Length/Height in Critically Ill Children

University Hospital, Strasbourg, France1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2018年2月26日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
140
试验地点
1
主要终点
identify the most reliable method (s) of pediatric resuscitation.

研究概览

简要总结

Height/length has to be assessed accurately in critically ill children, as its value is required to assess nutritional status, to calculate nutritional requirements, to calculate body surface area (involved in drug prescriptions), and to assess pulmonary function.

The WHO has standardized practices to perform height/length measurements, but this gold standard is not applicable in critically ill children (who cannot stand and are equipped with catheters, tubes and various devices). It is not accurate to rely on previous measurements as children are continuously growing. No height/length measurement tool or method has been validated so far in this population, neither any estimation nor extrapolation methods.

The investigators aim to compare the WHO gold standard for height/length measurement to a list of other methods, validated in other children populations and currently used in the pediatric setting. We intend to compare each of them to the gold standard. The secondary objectives are to describe each height/length extrapolation or estimation method and to estimate the practical use of each method for critically ill children.

A prospective observational study is planned. 140 critically ill children admitted to pediatric intensive care unit (PICU) will be recruited.

Body segments (ulna, tibia, knee-heel, arm span) will be measured and length/height extrapolated from formulas used in different populations. Previous length/height measurements will be collected to draw growth curves and extrapolate actual length/height. Parents will be asked how tall their child is.

After PICU discharge, while the child meets WHO measurement standards, accurate length/height will be measured and compared to the results of the above mentioned techniques.

Comparison will be made in-between these results.

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
28 Days 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • age from 28 days to 18 years
  • admitted in pediatric intensive care
  • WHO standard not applicable
  • parent consent
  • Exclusion criteria:
  • expected death before discharge
  • expected that the child will not meet in the near future WHO standard criteria to measure height/length
  • growth > 5% height before meeting the WHO criteria
  • limb abnormalities, scoliosis, retractions.

排除标准

  • 未提供

结局指标

主要结局

identify the most reliable method (s) of pediatric resuscitation.

时间窗: 110 days

Compare a series of measurement or size estimation techniques to the WHO standard to identify the most reliable method (s) of pediatric resuscitation.

次要结局

未报告次要终点

研究者

发起方
University Hospital, Strasbourg, France
申办方类型
Other
责任方
Sponsor

研究点 (1)

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