Skip to main content
OpenTrials
Completed

NCT Number: NCT02820818

Pulmonary Outcomes of Bronchopulmonary Dysplasia in Young Adulthood

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.

Completed

Looking for future studies?

Notify Me

Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Lung parenchymal tissue density

    Time frame: Baseline

    Pulmonary 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 outcomes

  1. Ventilation defect

    Time frame: Baseline

    Thoracic hyperpolarized 129Xe MRI to measure apparent diffusion coefficient (ADC) - subgroup of 10 participants (5 preterm, 5 control)

  2. Pulmonary function - airflow limitation

    Time frame: Baseline

    Spirometry (FEV1/FVC) will be performed according to the American Thoracic Society guidelines

  3. Pulmonary function - lung volumes

    Time frame: Baseline

    Lung volumes (RV/TLC) by plethysmography will be performed according to the American Thoracic Society guidelines

  4. Pulmonary function - diffusion lung capacity

    Time frame: Baseline

    DLCO will be performed according to the American Thoracic Society guidelines

  5. Pulmonary function - ventilation homogeneity

    Time frame: Baseline

    Lung clearance index by nitrogen washout will be performed according to the American Thoracic Society guidelines

Other outcomes

  1. Inflammatory and oxidative stress markers

    Time frame: Baseline

    Oxidative stress markers glutathione (GSH, GSSG; by capillary zone Electrophoresis) with calculation of Redox potential by the Nernst equation

  2. Pneumoproteins SP-D

    Time frame: Baseline

    Surfactant protein D (plasma)

  3. Pneumoproteins CCSP-16

    Time frame: Baseline

    CCSP-16 (plasma)

Sponsors and collaborators

Lead sponsor

St. Justine's Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2021
First posted
Jul 1, 2016
Registry last updated
Apr 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.