An observational study in Protracted Bacterial Bronchitis, sponsored by Sheffield Children's NHS Foundation Trust. Recruiting at 1 site in United Kingdom. Open to participants aged 5 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-05-06.
Sponsored by Sheffield Children's NHS Foundation Trust · Observational
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.
156 studies on the registry are indexed under Bronchitis; 21 are open to participants now.
This study's planned enrollment of 30 is below the median of 1,000 across 45 observational studies indexed under Bronchitis.
Browse Bronchitis studies →Sheffield Children's NHS Foundation Trust is the lead sponsor of 53 studies on the registry; 10 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
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Male and female children aged 5 to 17 years old
Exclusion Criteria:
Outside of age range
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
MRI
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
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
Any abnormalities found will be compared against standard clinical assessments including findings on CT imaging, bronchoscopy and spirometry.
Time frame: At time of MRI
Started Dec 2023 (actual). Primary completion is estimated for May 2026, 29 months after the start.
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Sheffield Children's NHS Foundation Trust