跳至主要内容
临床试验/NCT07545304
NCT07545304招募中不适用

Functional and Structural Imaging of the Lung Using Hyperpolarised Gas and Proton Magnetic Resonance Imaging for the Assessment of Lung Function in Paediatrics

Sheffield Children's NHS Foundation Trust1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
30
试验地点
1
主要终点
The primary analysis will be to compare the measured VDP and VHI from patients with PBB to previously collated data from healthy children.

研究概览

简要总结

Protracted bacterial bronchitis (PBB) is a problem in the lungs causing children to have a wet cough for more than 4 weeks. PBB is also known to start before and cause other lung diseases and to affect children's quality of life. It is difficult to know if a child has PBB. Listening to the lungs and measuring a child's breathing are usually normal and so a bronchoscopy (looking in the lungs with a camera) and a type of lung scan called CT are needed to diagnose PBB. These tests involve children being put to sleep under anaesthetic (bronchoscopy) or exposed to radiation (CT) and so are not performed often. PBB is difficult to treat and antibiotics are given for many weeks to make children better. Often this doesn't stop the cough and antibiotics need to be injected into the child to treat the infection. Children have to take large amounts of antibiotics and have regular physiotherapy to help their cough. The only way to know if a child is better is when their parents report their cough has improved which is often unreliable. In this study we will take pictures of children's lungs using a type of scan called MRI, which is safe and does not expose children to radiation. Children breathe in a gas called xenon which fills the lungs. If there is phlegm blocking parts of the lungs, the gas cannot get through and we can see the blockage. This type of picture is the best way to measure early lung disease in children with other lung conditions such as cystic fibrosis and bronchiectasis. Measuring lung disease early will make children with PBBs lives better and mean they have to take less antibiotics. In some children, it will also help to stop lifelong lung diseases such as bronchiectasis.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Other

入排标准

年龄范围
5 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Male and female children aged 5 to 17 years old
  • High suspicion of PBB requiring bronchoscopy
  • Be able to follow instructions
  • English speaking family member

排除标准

  • Outside of age range
  • Significant learning difficulties or inability to follow instructions
  • Informed consent / assent has not been provided
  • No English-speaking member of the family
  • Contraindications for MRI scanning

结局指标

主要结局

The primary analysis will be to compare the measured VDP and VHI from patients with PBB to previously collated data from healthy children.

时间窗: At time of MRI

次要结局

  • The secondary analysis will include the scoring of the presence or absence of ventilation defects from 129Xe-MRI, bronchial wall thickening/bronchiectasis, mucus plugging and gas trapping from 1H MRI, as judged by an experienced paediatric radiologist.(At time of MRI)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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