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Within-day and Between-day Repeatability of the Breath Pattern in Healthy Children and in Children With Asthma (CERS)

2018年9月3日 更新者：Stefania La Grutta, MD、Istituto per la Ricerca e l'Innovazione Biomedica

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

"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.

研究概览

地位

完全的

条件

干预/治疗

研究类型

观察性的

注册 (实际的)

45

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 意大利
    • Sicily
      • Palermo、Sicily、意大利、90146
        • Institute of Biomedicine and Molecular Immunology (IBIM), National Research Council

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

6年 至 11年 (孩子)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

A study population of 15 asthmatic children (moderate asthma) attending the 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).

A control group of healthy children (n=30), recruited from the primary schools involved in the municipal project "educational pathways" (Palermo, Italy) to which the PAP group partecipates.

描述

The inclusion criteria for asthmatic children are:

  1. Moderate asthma (GINA 2015);
  2. Age 6-11 years;
  3. No upper airway respiratory infections or exacerbations in the last 4 weeks;
  4. Steroid-naive asthma;
  5. Positive bronchodilator response;
  6. Non smoker.

The inclusion criteria for healthy children are:

  1. Age 6-11 years;
  2. No upper airway respiratory infections in the last 4 weeks;
  3. Non smoker;
  4. No history of asthma and respiratory diseases during the life;
  5. Negative bronchodilator response.

The exclusion criteria are:

  1. Symptoms of acute respiratory infection;
  2. Immunological and metabolic systemic disease;
  3. Major malformations of the upper airways;
  4. Active smoker.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

队列和干预

团体/队列
干预/治疗
15 children with moderate asthma
Assessment of E-nose measurements: three E-nose measurements on 15 children with moderate asthma (of both sex and 6-11 years old): first measurement, second one after 30 minutes, third one after 7 days. These children attend the 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).
其他：Assessment of E-nose measurements
Breath sampling through E-nose pneumopipe
30 healthy children
Assessment of E-nose measurements: three E-nose measurements on 30 healthy children (of both sex and 6-11 years old): first measurement, second one after 30 minutes, third one after 7 days. These children attend the primary schools involved in the municipal project "Educational Pathways" (Palermo).
其他：Assessment of E-nose measurements
Breath sampling through E-nose pneumopipe

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Electronic nose measurements
大体时间：1 week
Several volatile organic compounds, including isoprene, 1,2-pentadiene, acetone, ethanol, pentane and ethane, identified in exhaled breath.
1 week

次要结果测量

结果测量
大体时间
Fraction of Exhaled Nitric Oxide (FeNO)
大体时间：1 week
1 week
Pulmonary function (FEV1, FVC, etc.)
大体时间：1 week
1 week

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Istituto per la Ricerca e l'Innovazione Biomedica

合作者

Campus Bio-Medico University

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2017年2月24日

初级完成 (实际的)

2018年8月3日

研究完成 (实际的)

2018年8月3日

研究注册日期

首次提交

2017年1月16日

首先提交符合 QC 标准的

2017年1月16日

首次发布 (估计)

2017年1月19日

研究记录更新

最后更新发布 (实际的)

2018年9月5日

上次提交的符合 QC 标准的更新

2018年9月3日

最后验证

2018年9月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 5/2016

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

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