Protracted Bacterial BronchitisNCT07545304
Lung MRI in Paediatric Lung Disease: MRI in PBB
An observational study of Protracted Bacterial Bronchitis, run by Sheffield Children's NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 5 to 17 years
- Conditions the study is for
- Protracted Bacterial Bronchitis
- What is being tested?
- MRI
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Dec 2023to 31 May 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 17 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Sheffield Children's Hospital
Sheffield, S10 2TH
Nicki Barker, 01142717227, nicki.barker@nhs.net
About this study
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
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.
- Conditions
- Protracted Bacterial Bronchitis
- Being tested
- MRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIProcedure or surgery
MRI
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary analysis will be to compare the measured VDP and VHI from patients with PBB to previously collated data from healthy children.
Measured: At time of MRI
Secondary outcomes (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.
Measured: At time of MRI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2026
- Study start1 Dec 2023
- Primary completion31 May 2026 (estimated)
- Study completion31 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Protracted Bacterial BronchitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheffield Children's NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07545304
- Sponsor's protocol ID
- SCH-2800
- Status last verified
- Apr 2026
- First submitted
- 15 Apr 2026
- Last updated
- 6 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07545304
- Acronym / sponsor ID
- SCH-2800
- Conditions
- Protracted Bacterial Bronchitis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sheffield Children's NHS Foundation TrustUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 22 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRIMRI | Procedure or surgery | – |
Primary outcome
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
1 secondary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Protracted Bacterial Bronchitis, run by Sheffield Children's NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicki Barker (01142717227, nicki.barker@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.