跳至主要内容
临床试验/NCT04239287
NCT04239287Unknown不适用

Lung Function and Exercise Response Measured by Optoelectronic Plethysmography in School-aged Children Born Preterm

Newcastle-upon-Tyne Hospitals NHS Trust1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2019年9月2日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
60
试验地点
1
主要终点
Change in end-expiratory lung volume with exercise

研究概览

简要总结

This study will explore lung function and respiratory health in school-aged children who were born prematurely at <32 weeks gestation. It will involve full lung function assessment, a questionnaire and discussion about respiratory health, and an exercise test using optoelectronic plethysmography (OEP) to measure breathing patterns.

详细描述

Preterm are born during a critical stage of lung development, and can have abnormalities in lung function that persist with age. Previous studies have shown that children with BPD have reduced lung function and limited exercise capacity. These studies have used conventional lung function testing which requires a tight fitting mask. This is uncomfortable, may alter normal breathing patterns and cannot measure changes in total lung volume.

Optoelectronic plethysmography (OEP) indirectly measures lung volumes and breathing patterns using cameras to track the position of marker stickers on the chest, back and abdomen. It is comfortable, does not require a mask and allows us to track changes in total lung volume.

This study will use standard lung function testing and OEP to measure lung function and breathing patterns at rest and during exercise in school-aged children born prematurely, compared to healthy children born at full term. All participants will complete standard lung function tests, a questionnaire and structured interview to qualitatively assess respiratory health, and an exercise test using OEP to assess how breathing changes with exercise.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
8 Years 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Age 8-16 years
  • Born at <32 weeks gestation (preterm) or >37 weeks gestation (controls)
  • Parental consent obtained

排除标准

  • Unable to comply with test procedure
  • Respiratory illness within last 2 weeks
  • Cardiac disease (excludes ligated PDA)
  • Neuromuscular disease

结局指标

主要结局

Change in end-expiratory lung volume with exercise

时间窗: Pre + post exercise (10minutes)

Change in end-expiratory lung volume measured in litres with exercise measured using optoelectronic plethysmography

次要结局

  • Forced vital capacity (FVC)(Baseline)
  • Forced mid-expiratory flow (FEF25-75%)(Baseline)
  • Change in tidal volume with exercise(During exercise (10 minutes))
  • Change in minute ventilation with exercise(During exercise (10 minutes))
  • Baseline forced expiratory volume in 1 second (FEV1)(Baseline)
  • Transfer factor for carbon monoxide (TLCO)(Baseline)
  • Body plethysmography(Baseline)
  • FeNO(Baseline)
  • Exercise induced bronchoconstriction(10 minutes post exercise)
  • Baseline activity levels(1 week period)

研究者

发起方
Newcastle-upon-Tyne Hospitals NHS Trust
申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验