Bronchopulmonary DysplasiaNCT03475264
MRI of Lung Structure and Function in Preterm Children
An observational study of Bronchopulmonary Dysplasia, run by The Hospital for Sick Children at 1 site in Canada.
Trial summary
The MRI tools developed by the investigators are well positioned for assessing regional changes in lung structure and function in preterm children with bronchopulmonary dysplasia (BPD), in which airway limitation similar to asthma, alveolar simplification similar to emphysema and pulmonary vascular stunting are… Read more about this study
- Who is it for?
- Ages 6 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Bronchopulmonary Dysplasia
- What is being tested?
- Lung MRI
- How many people
- 12 participants
- Where
- 1 siteCanada
- Study dates
- 1 Sep 2018to 8 Oct 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
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 6 to 9 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Healthy volunteers will be selected from the general population and the BPD and non-BPD cohorts will be selected from patients from clinics seen at the Hospital for Sick Children, Toronto
Who may be able to join
- Children born pre-term at less than 28 weeks' gestation, currently aged 6-9 years, with and without BPD will be included.
- For the preterm non-BPD cohort, inclusion will include
- no requirement of supplementary oxygen beyond 28 days from birth. For the BPD preterm cohort, inclusion criteria will include
- need for oxygen at 36 weeks' postmenstrual age, which includes those with moderate-severe disease .
- For the healthy cohort, inclusion will include
- -absence of any diagnosed pulmonary disease and term birth.
Who cannot join
- known interstitial lung disease, congenital lung anomalies, cystic fibrosis, ciliary dysfunction, immunodeficiency, neuromuscular disease or structural heart disease, which may have associated pulmonary function tests (PFT) and/or MRI findings;
- genetic syndromes which may have other associated structural lung anomalies;
- any contraindications for MRI
- severe neurosensory deficits which would prevent test completion;
- viral or bacterial respiratory infection within 6 weeks will be excluded. For all three groups (healthy, preterm non-BPD and preterm BPD), we will exclude
- those with congenital lung disease (i.e. Congenital diaphragmatic hernia (CDH), lung cysts) or non BPD acquired chronic lung disease as defined by need for any routine supplementary oxygen
- if the participant has an MRI incompatible device or any metal in their body which cannot be removed, including but not limited to pacemakers, neurostimulators, biostimulators, implanted insulin pumps, aneurysm clips, bio prosthetic, artificial limb, metallic fragment or foreign body, shunt, surgical staples (including clips or metallic sutures and/or ear implants).
Trial locations and contacts
1 site in 1 country.
About this study
The MRI tools developed by the investigators are well positioned for assessing regional changes in lung structure and function in preterm children with bronchopulmonary dysplasia (BPD), in which airway limitation similar to asthma, alveolar simplification similar to emphysema and pulmonary vascular stunting are expected. To the investigator's knowledge, the combination of ultra short echo time (UTE) proton, pulmonary vascular proton and hyperpolarized 129Xe MRI have not yet been explored in BPD, either clinically or preclinically. The investigators propose that a comprehensive MRI examination may be useful from a diagnostic perspective, MRI of preterm children without BPD may reveal changes which are otherwise clinically 'silent' yet still place children at risk for future chronic lung disease in later life.
Read the detailed description
Briefly, at the beginning of an approximate three hour study visit, the qualified investigator (QI) / delegate will explain the study procedure to the participants and the participants will have an opportunity to ask questions regarding the study procedure. Following the explanation of the study, written informed consent will be collected at the beginning of visit 1. Participants who are deemed unable to provide consent will be provided an assent form and consent will be acquired from their parents/ legal guardians. During the study visit, participants will undergo: 1) brief medical history and clinical examination including questionnaires, 2) full pulmonary function tests, lung clearance testing (LCI), forced oscillation technique (FoT) and exercise testing, 3) proton MRI, 4) spin-density and/or diffusion-weighted 129Xe MRI, 5) Multiple-breath washout imaging. Qualified research team members will perform a clinical examination on the participant to record their vital statistics like age, gender, height, weight, heart rate, respiratory rate, oral temperature and blood pressure. The QI/delegate, during a brief conversation with the participant, will collect relevant medical history from the participant to make sure the participant meets all the inclusion/exclusion criteria for the study. The QI will also make sure that the participant understands the study procedure and is willing to participate in the study. Based on the clinical examination results, medical history and the pulmonary function test results, the QI/delegate will determine if all the inclusion/exclusion criteria are met to proceed with the MRI part of the study visit.
- Conditions
- Bronchopulmonary Dysplasia
- Being tested
- Lung MRI
- Keywords
- Lung MRI, Bronchopulmonary Dysplasia, hyperpolarized xenon,
- Medical subject headings
- Bronchopulmonary Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung MRIDiagnostic test
Participants will be undergoing hyperpolarized xenon and proton lung MRI
| Study group | Role | What they receive |
|---|---|---|
| Healthy | Healthy Participants Receives: Diagnostic Test: Lung MRI | |
| BPD cohort | Participants born prematurely with a diagnosis of BPD Receives: Diagnostic Test: Lung MRI | |
| Non-BPD cohort | Participants born prematurely without a diagnosis of BPD Receives: Diagnostic Test: Lung MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
MRI ventilation and 1H MRI thoracic cavity volume and tissue density
Ventilation defect percent (VDP) (%) will be generated for whole lung and individual lung slices using manual or semi-automated segmentation. For proton (1H) thoracic cavity images, the thoracic cavity volume (TCV) will be calculated by manual or semi-automated segmentation.
Measured: 2 years
Secondary outcomes (2)
Apparent Diffusion Coefficients (ADC) and ADC maps
Diffusion weighted images from each visit will be reviewed and compared with the proton anatomical images. Mean, whole lung, and center slice ADC (and standard deviation) will be calculated and recorded.
Measured: 2 years
Multiple breath washout testing:
VDP will be calculated as described above based on the first image data set prior to wash-out breaths. A pixel-by-pixel fit of images as a function of washout breath number will then be used to calculate the fractional ventilation map defined as the volume of expired gas leaving a volume divided by its end-inspiratory volume.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2018
- Study start1 Sep 2018
- Primary completion8 Oct 2019
- Study completion8 Oct 2019
Why it stopped: Recruitment and Funding challenges
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bronchopulmonary DysplasiaStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giles Santyr, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03475264
- Sponsor's protocol ID
- 1000055897
- Status last verified
- Jul 2025
- First submitted
- 6 Feb 2018
- Last updated
- 1 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared with other researchers outside of the institutions
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MRI of Lung Structure and Function in Preterm Children
- ClinicalTrials.gov ID
- NCT03475264
- Acronym / sponsor ID
- 1000055897
- Conditions
- Bronchopulmonary Dysplasia
- Keywords
- Lung MRI, Bronchopulmonary Dysplasia, hyperpolarized xenon,
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Recruitment and Funding challenges
- Enrolment
- 12 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 8 Oct 2019 (actual)
- Study completion
- 8 Oct 2019 (actual)
- First posted
- 23 Mar 2018 (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.
The MRI tools developed by the investigators are well positioned for assessing regional changes in lung structure and function in preterm children with bronchopulmonary dysplasia (BPD), in which airway limitation similar to asthma, alveolar simplification similar to emphysema and pulmonary vascular stunting are expected. To the investigator's knowledge, the combination of ultra short echo time (UTE) proton, pulmonary vascular proton and hyperpolarized 129Xe MRI have not yet been explored in BPD, either clinically or preclinically. The investigators propose that a comprehensive MRI examination may be useful from a diagnostic perspective, MRI of preterm children without BPD may reveal changes which are otherwise clinically 'silent' yet still place children at risk for future chronic lung disease in later life.
Detailed description
Briefly, at the beginning of an approximate three hour study visit, the qualified investigator (QI) / delegate will explain the study procedure to the participants and the participants will have an opportunity to ask questions regarding the study procedure. Following the explanation of the study, written informed consent will be collected at the beginning of visit 1. Participants who are deemed unable to provide consent will be provided an assent form and consent will be acquired from their parents/ legal guardians. During the study visit, participants will undergo: 1) brief medical history and clinical examination including questionnaires, 2) full pulmonary function tests, lung clearance testing (LCI), forced oscillation technique (FoT) and exercise testing, 3) proton MRI, 4) spin-density and/or diffusion-weighted 129Xe MRI, 5) Multiple-breath washout imaging. Qualified research team members will perform a clinical examination on the participant to record their vital statistics like age, gender, height, weight, heart rate, respiratory rate, oral temperature and blood pressure. The QI/delegate, during a brief conversation with the participant, will collect relevant medical history from the participant to make sure the participant meets all the inclusion/exclusion criteria for the study. The QI will also make sure that the participant understands the study procedure and is willing to participate in the study. Based on the clinical examination results, medical history and the pulmonary function test results, the QI/delegate will determine if all the inclusion/exclusion criteria are met to proceed with the MRI part of the study visit.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy | – | Diagnostic Test: Lung MRIHealthy Participants |
| BPD cohort | – | Diagnostic Test: Lung MRIParticipants born prematurely with a diagnosis of BPD |
| Non-BPD cohort | – | Diagnostic Test: Lung MRIParticipants born prematurely without a diagnosis of BPD |
Who may qualify
- Ages
- 6 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Healthy volunteers will be selected from the general population and the BPD and non-BPD cohorts will be selected from patients from clinics seen at the Hospital for Sick Children, Toronto
Key inclusion criteria (6 listed)
- Children born pre-term at less than 28 weeks' gestation, currently aged 6-9 years, with and without BPD will be included.
- For the preterm non-BPD cohort, inclusion will include
- no requirement of supplementary oxygen beyond 28 days from birth. For the BPD preterm cohort, inclusion criteria will include
- need for oxygen at 36 weeks' postmenstrual age, which includes those with moderate-severe disease .
- For the healthy cohort, inclusion will include
Key exclusion criteria (7 listed)
- known interstitial lung disease, congenital lung anomalies, cystic fibrosis, ciliary dysfunction, immunodeficiency, neuromuscular disease or structural heart disease, which may have associated pulmonary function tests (PFT) and/or MRI findings;
- genetic syndromes which may have other associated structural lung anomalies;
- any contraindications for MRI
- severe neurosensory deficits which would prevent test completion;
- viral or bacterial respiratory infection within 6 weeks will be excluded. For all three groups (healthy, preterm non-BPD and preterm BPD), we will exclude
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 |
|---|---|---|
| Lung MRIParticipants will be undergoing hyperpolarized xenon and proton lung MRI | Diagnostic test | BPD cohort, Healthy, Non-BPD cohort |
Primary outcome
MRI ventilation and 1H MRI thoracic cavity volume and tissue density
Time frame: 2 years
Ventilation defect percent (VDP) (%) will be generated for whole lung and individual lung slices using manual or semi-automated segmentation. For proton (1H) thoracic cavity images, the thoracic cavity volume (TCV) will be calculated by manual or semi-automated segmentation.
2 secondary outcomes
Apparent Diffusion Coefficients (ADC) and ADC maps
Time frame: 2 years
Multiple breath washout testing:
Time frame: 2 years
Results and safety
The study was stopped early (reason given: Recruitment and Funding challenges). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2025.
- Individual participant dataSharing planned: No. IPD will not be shared with other researchers outside of the institutions
Related trials for Bronchopulmonary Dysplasia
RecruitingPhase 4
Impact of Higher Zinc Supplementation on Neonatal Weight Velocity
Extreme Prematurity,Extremely Low Birthweight, BPD - Bronchopulmonary Dysplasia
Not yet recruiting
Strap To Reduce Apnea in Preterm Infants: A Randomized Crossover Trial
Apnea of Prematurity, Intermittent Hypoxemia
Recruiting
Ventilator Pressure and Optimization of Compliance and Hemodynamics
Bronchopulmonary Dysplasia, Pulmonary Hypertension Due to Lung Diseases and Hypoxia
Recruiting
Restricted Versus Liberal Fluid Intake for Prevention of Bronchopulmonary Dysplasia
Bronchopulmonary Dysplasia
RecruitingObservational study
The Correlation Between Red Cell Transfusion and Complications of Prematurity
Retinopathy of Prematurity (ROP), Bronchopulmonary Dysplasia (BPD)
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Bronchopulmonary Dysplasia, run by The Hospital for Sick Children at 1 site in Canada.
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 6 inclusion and 7 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: stopped early, as of the sponsor's last update on 1 Aug 2025. 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 Canada. 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?
The study was stopped early (reason given: Recruitment and Funding challenges). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MRI ventilation and 1H MRI thoracic cavity volume and tissue density (time frame: 2 years). 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 1 Aug 2025.