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Recruiting NCT07545304

Lung MRI in Paediatric Lung Disease: MRI in PBB

Observational Protracted Bacterial Bronchitis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: MRI.
Who it may be relevant to
Registry conditions: Protracted Bacterial Bronchitis. Basic parameters: 5 years — 17 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United Kingdom
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • Procedure MRI
    MRI

Primary outcome measures

  • The primary analysis will be to compare the measured VDP and VHI from patients with PBB to previously collated data from healthy children. [Time frame: At time of MRI]
Secondary outcome measures (1)
  • 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. [Time frame: At time of MRI]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

United Kingdom · 1 center
  • Sheffield Children's Hospital — Sheffield

Identifiers

NCT: NCT07545304 · SCH-2800

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗