Bronchopulmonary Dysplasia: From Neonatal Chronic Lung Disease to Early Onset Adult COPD

Brief Title

Bronchopulmonary Dysplasia: From Neonatal Chronic Lung Disease to Early Onset Adult COPD

Official Title

Bronchopulmonary Dysplasia: From Neonatal Chronic Lung Disease to Early Onset Adult Chronic Obstructive Pulmonary Disease

Brief Summary

      The investigators will apply xenon-129 (129Xe) and non-contrast enhanced magnetic resonance
      imaging (MRI) acquisition and analysis methods in 50 subjects aged between 20 and 29 years
      born pre-term (with and without a diagnosis of bronchopulmonary dysplasia [BPD]) and at term
      to characterize and probe the relationship between lung structure and function using imaging.
    

Detailed Description

      This is a pilot, cross-sectional exploratory study to evaluate the relationship between
      imaging and other biomarkers in fifty patients born pre-term (with or without
      bronchopulmonary dysplasia [BPD]) and age-matched healthy controls. The term-born adults will
      serve as the controls.

      All subjects will visit the Clinical Imaging Research Laboratories at Robarts Research
      Institute or the University of Montreal University Health Centre Sainte-Justine in a single
      visit and undergo: vital signs, pulmonary function testing (more specifically: spirometry,
      body plethysmography, airwave oscillation, and lung clearance index), questionnaires, proton
      and 129Xe MRI. Preterm patients will also have a low-dose chest computed tomography (CT), and
      have blood and urine samples taken for biomarkers of inflammation and oxidative stress.

      MRI of the lungs will be performed using non-contrast enhanced methods (ultra-short echo time
      [UTE] MRI) and using an inhaled contrast agent: Hyperpolarized Xenon-129. Participants will
      inhale the hyperpolarized gas and perform a breathhold for up to 16 seconds. Four different
      types of images will be acquired in the coronal plain during each visit: 1) 1H thoracic
      cavity, 2) 129Xe static ventilation, 3) 129Xe diffusion weighted imaging, and, 4)
      multi-volume UTE MRI. Respiration and oxygen saturation will be monitored throughout the
      imaging session.
    

Study Type

Interventional

Primary Outcome

Number of patients with MRI-derived tissue signal intensity less than normal for age-matched individuals without BPD

Secondary Outcome

 Forced Expiratory Volume in 1 s (FEV1) measured using spirometry

Condition

Bronchopulmonary Dysplasia

Intervention

Hyperpolarized Xenon-129

Study Arms / Comparison Groups

 Preterm Adults

Description:  All enrolled preterm adults will undergo non-contrast enhanced MRI (using ultra-short echo time methods), hyperpolarized noble gas MRI (using hyperpolarized xenon-129), x-ray computed tomography (CT), pulmonary function tests, and questionnaires in a single visit.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Other

Estimated Enrollment

50

Start Date

April 1, 2016

Completion Date

April 2021

Primary Completion Date

April 2021

Eligibility Criteria

        Inclusion Criteria:

          -  20-29 years old

          -  Pre-term (<29 weeks gestational age) with or without a diagnosis of bronchopulmonary
             dysplasia (BPD) or term born controls

          -  Subject understands the study procedures and is willing to participate in the study as
             indicated by the signature on the informed consent

          -  Subject is judged to be in otherwise stable health on the basis of medical history

          -  Subject is able to perform reproducible pulmonary function testing (i.e., the 3 best
             acceptable spirograms have FEV1 values that do not vary more than 5% of the largest
             value or more than 100 ml, whichever is greater)

        Exclusion Criteria:

          -  Patient is, in the opinion of the investigator, mentally or legally incapacitated,
             preventing informed consent from being obtained, or cannot read or understand the
             written material

          -  Patient is unable to perform spirometry or plethysmography maneuvers

          -  Subject has an implanted mechanically, electrically or magnetically activated device
             or any metal in their body which cannot be removed, including but not limited to
             pacemakers, neurostimulators, biostimulators, implanted insulin pumps, aneurysm clips,
             bioprosthesis, artificial limb, metallic fragment or foreign body, shunt, surgical
             staples (including clips or metallic sutures and/or ear implants)(at the discretion of
             the MRI Technologist/3T Manager)

          -  In the investigator's opinion, subject suffers from any physical, psychological or
             other condition(s) that might prevent performance of the MRI, such as severe
             claustrophobia

          -  Patient is pregnant
      

Gender

All

Ages

20 Years - 29 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Grace Parraga, PhD, 519-931-5265, [email protected]

Location Countries

Canada

Location Countries

Canada

NCT ID

NCT02723513

Organization ID

ROB0041

Responsible Party

Principal Investigator

Study Sponsor

Western University, Canada

Collaborators

 Université de Montréal

Study Sponsor

Grace Parraga, PhD, Principal Investigator, Western University, Canada

Verification Date

September 2019