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Pulmonary MRI of Ex-preterm Children With and Without BPD To Understand Risk of Emphysematous Changes

NCT02921308 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 45

Last updated 2020-07-31

No results posted yet for this study

Summary

Health Issue: Bronchopulmonary dysplasia (BPD), a chronic lung disease, is the most common complication of being born premature. Damage to the still developing lung stops the normal formation of the alveoli. Young adults with a history of BPD have lower lung function, early heart disease, and increased risk of death, compared to those without BPD. Recently, it has been reported that they may also develop a type of lung disease typically seen in older adults with a longstanding history of smoking. The severity of lung disease is usually measured using pulmonary function tests (PFT), but these tests may be normal, even in the presence of important changes in the fine structure of the lung. Such structural changes may be early markers of future lung disease and can be detected using lung magnetic resonance imaging (MRI). Unlike other ways of imaging the lungs, MRI does not expose people to harmful X-rays. To date, no studies have been done to examine the fine structure of the lung of school-aged children who had a history of BPD, to determine whether there are signs of lung disease that might not otherwise be obvious. This is important because once armed with this information, preventive measures can be taken to avoid worsening of lung disease.

Objective: 1) In 7-9 year-old children born extremely premature, lung MRI will be compared between those with and without BPD. The Investigators expect to observe more severe structural lung abnormalities in children with BPD, compared to those without BPD; 2) The Investigators will test to see if children with more severe MRI abnormalities also have worse lung function, and/or more symptoms of breathing problems. The Investigators expect to observe more PFT abnormalities in children with BPD than in those without and that these will match up with lung fine structure abnormalities identified on MRI.

How will work be undertaken? Children 7-9 years old who were born extremely prematurely will be recruited to participate in this study. Participants will be identified from Neonatal Follow-up clinics they attended. The Investigators will enroll 20 children with BPD and 20 without BPD. Participants will have lung MR images taken, during which they need to lie still for a few minutes. PFT will also be performed, during which they will blow into a machine. Parents will be asked to complete questionnaires about breathing problems, their living conditions (environment) and any doctor visits or hospital stays. Medical charts will be reviewed for information about their birth.

Unique/Innovative Aspects: This will be the first study using MRI as an innovative way to visualize and measure fine structure of the lung in children born prematurely with and without BPD. These findings may be early markers of lung disease, which would identify children who have, or are at risk of developing lung disease later in life, for whom the Investigators may be able to offer treatments now and/or prevent worsening of lung disease.

Conditions

  • Bronchopulmonary Dysplasia

Sponsors & Collaborators

  • Children's Hospital of Eastern Ontario

    lead OTHER

Principal Investigators

  • Sherri Katz · Children's Hospital of Eastern Ontario

Eligibility

Min Age
7 Years
Max Age
9 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-05
Primary Completion
2019-09-18
Completion
2019-09-18

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02921308 on ClinicalTrials.gov