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Pulmonary Outcomes of Bronchopulmonary Dysplasia in Young Adulthood

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02820818
Enrollment
50
Registered
2016-07-01
Start date
2016-06-30
Completion date
2021-12-31
Last updated
2024-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bronchopulmonary Dysplasia, Obstructive Lung Disease, Premature Birth

Keywords

thoracic magnetic resonance imaging, pulmonary function test

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.

Interventions

None listed

Sponsors

St. Justine's Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
20 Years to 29 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Lung parenchymal tissue densityBaselinePulmonary hydrogen protons (1H) magnetic resonance imaging (MRI) using ultra-short echo time pulse sequences will be performed to quantify signal intensity (SI) as a surrogate of parenchymal tissue density.

Secondary

MeasureTime frameDescription
Pulmonary function - airflow limitationBaselineSpirometry (FEV1/FVC) will be performed according to the American Thoracic Society guidelines
Pulmonary function - lung volumesBaselineLung volumes (RV/TLC) by plethysmography will be performed according to the American Thoracic Society guidelines
Pulmonary function - diffusion lung capacityBaselineDLCO will be performed according to the American Thoracic Society guidelines
Pulmonary function - ventilation homogeneityBaselineLung clearance index by nitrogen washout will be performed according to the American Thoracic Society guidelines
Ventilation defectBaselineThoracic hyperpolarized 129Xe MRI to measure apparent diffusion coefficient (ADC) - subgroup of 10 participants (5 preterm, 5 control)

Other

MeasureTime frameDescription
Pneumoproteins CCSP-16BaselineCCSP-16 (plasma)
Pneumoproteins SP-DBaselineSurfactant protein D (plasma)
Inflammatory and oxidative stress markersBaselineOxidative stress markers glutathione (GSH, GSSG; by capillary zone Electrophoresis) with calculation of Redox potential by the Nernst equation

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026