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临床试验/NCT03025061
NCT03025061已完成不适用

Within-day and Between-day Repeatability of the Breath Pattern in Healthy Children and in Children With Moderate Asthma

Istituto per la Ricerca e l'Innovazione Biomedica1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2017年2月24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
45
试验地点
1
主要终点
Electronic nose measurements

研究概览

简要总结

"Within-day and Between-day Repeatability of the Breath Pattern in Healthy Children and in Children With Moderate Asthma" is an observational prospective study in outpatient clinic of Pediatric Allergology & Pulmonology (PAP) within the Institute of Biomedicine and Molecular Immunology (IBIM) of the National Research Council (CNR) of Palermo (IBIM CNR), Italy.

The electronic nose (E-nose) has been proposed as a novel, non-invasive tool to evaluate the level of airway inflammation for different respiratory diseases, especially in children. To date, there are no data on the within-day and the between-day repeatability of the breath pattern in healthy children and in children with moderate asthma.

The breath pattern will be analyzed by collecting, for each child, three samples of the breath through the E-nose. Within-day repeatability will be assessed using two consecutive measurements (the second one after 30 minutes). Between-day repeatability will be assessed using a third measurement repeated after 7 days.

The study is expected to provide information about the accuracy of E-nose measurements for a child population.

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
6 Years 至 11 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Electronic nose measurements

时间窗: 1 week

Several volatile organic compounds, including isoprene, 1,2-pentadiene, acetone, ethanol, pentane and ethane, identified in exhaled breath.

次要结局

  • Fraction of Exhaled Nitric Oxide (FeNO)(1 week)
  • Pulmonary function (FEV1, FVC, etc.)(1 week)

研究者

发起方
Istituto per la Ricerca e l'Innovazione Biomedica
申办方类型
Other
责任方
Principal Investigator
主要研究者

Stefania La Grutta, MD

MD. Senior Researcher. Coordinator of Pediatric Allergy and Asthma Research Group. Institute of Biomedicine and Molecular Immunology, IBIM, National Research Council of Palermo, Italy.

Istituto per la Ricerca e l'Innovazione Biomedica

研究点 (1)

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