- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07545304
Lung MRI in Paediatric Lung Disease: MRI in PBB
April 29, 2026 updated by: Sheffield Children's NHS Foundation Trust
Functional and Structural Imaging of the Lung Using Hyperpolarised Gas and Proton Magnetic Resonance Imaging for the Assessment of Lung Function in Paediatrics
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
30
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Nicki Barker
- Phone Number: 01142717227
- Email: nicki.barker@nhs.net
Study Locations
-
-
-
Sheffield, United Kingdom, S10 2TH
- Recruiting
- Sheffield Children's Hospital
-
Contact:
- Nicki Barker
- Phone Number: 01142717227
- Email: nicki.barker@nhs.net
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Participants will be recruited from the Respiratory service at Sheffield Children's Hospital.
There are approximately 200 children with PBB diagnosed a year, of which 50 are aged 5 or above.
The majority of these children will be eligible for inclusion in the study as most undergo bronchoscopy.
It is expected that a high proportion of families will opt for their children to take part in the study due to low risks associated with the 129Xe-MRI being carried out and the benefit of additional clinical information becoming available.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
|
At time of MRI
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
|
At time of MRI
|
Other Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Any abnormalities found will be compared against standard clinical assessments including findings on CT imaging, bronchoscopy and spirometry.
Time Frame: At time of MRI
|
At time of MRI
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2023
Primary Completion (Estimated)
May 31, 2026
Study Completion (Estimated)
May 31, 2026
Study Registration Dates
First Submitted
April 15, 2026
First Submitted That Met QC Criteria
April 15, 2026
First Posted (Actual)
April 22, 2026
Study Record Updates
Last Update Posted (Actual)
May 6, 2026
Last Update Submitted That Met QC Criteria
April 29, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Other Study ID Numbers
- SCH-2800
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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