Clinical trial NCT02820818: Pulmonary Outcomes of Bronchopulmonary Dysplasia in Young Adulthood
Official title: Bronchopulmonary Dysplasia: From Neonatal Chronic Lung Disease to Early Onset Adult COPD
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Premature Birth
Obstructive Lung Disease
Bronchopulmonary Dysplasia
Keywords: thoracic magnetic resonance imaging
pulmonary function test
Lead sponsor: St. Justine's Hospital
Sponsor class: OTHER
First posted: 2016-07-01
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 25 adults aged 20-29 born preterm (\<29 weeks); 25 sex and age-matched controls (friend or sibling).

Brief summary: Preterm birth alters the normal sequence of lung development with lasting respiratory consequences. It is still unclear whether observed respiratory morbidities in preterm born individuals reflect sequelae from a non-progressive lung disease that occurred early in life or result from ongoing active disease that, if left undiagnosed and untreated, could increase the risk of a COPD-like phenotype. We propose to examine micro-structural abnormalities of the lung using innovative non-invasive imaging technologies in relation to pulmonary function and markers of inflammation and oxidative stress in young adults born preterm.


Eligibility criteria: Inclusion Criteria:

* 20-29 years old
* For the pre-term subject: \<29 weeks gestational age, with or without BPD
* For the matched term control: ≥37 weeks gestational age with birth weight appropriate for gestational age i.e. between the 10th and 90th percentile
* 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

Primary outcomes:
measure: Lung parenchymal tissue density
timeFrame: Baseline
Secondary outcomes:
measure: Ventilation defect
timeFrame: Baseline
measure: Pulmonary function - airflow limitation
timeFrame: Baseline
measure: Pulmonary function - lung volumes
timeFrame: Baseline
measure: Pulmonary function - diffusion lung capacity
timeFrame: Baseline
measure: Pulmonary function - ventilation homogeneity
timeFrame: Baseline
Other outcomes:
measure: Inflammatory and oxidative stress markers
timeFrame: Baseline
measure: Pneumoproteins SP-D
timeFrame: Baseline
measure: Pneumoproteins CCSP-16
timeFrame: Baseline
Locations:
Study officials:
References: