CClinicalTrials.gg
CompletedNCT02820818Updated Apr 10, 2024

Pulmonary Outcomes of Bronchopulmonary Dysplasia in Young Adulthood

An observational study in Premature Birth, Obstructive Lung Disease and Bronchopulmonary Dysplasia, sponsored by St. Justine's Hospital. Completed. Open to participants aged 20 Years to 29 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-10.

Sponsored by St. Justine's Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
50
Ages
20 Years to 29 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Premature Birth
  • Obstructive Lung Disease
  • Bronchopulmonary Dysplasia

Keywords

  • thoracic magnetic resonance imaging
  • pulmonary function test
03

In context

Lung Diseases

3,303 studies on the registry are indexed under Lung Diseases; 355 are open to participants now.

This study's planned enrollment of 50 is below the median of 157 across 929 observational studies indexed under Lung Diseases.

Browse Lung Diseases studies →

Lead sponsor

St. Justine's Hospital is the lead sponsor of 155 studies on the registry; 27 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 29 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
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).

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

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
05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
50 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna
06

What researchers measure

Primary outcomes

  1. Lung parenchymal tissue density

    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.

    Time frame: Baseline

Secondary outcomes

  1. Ventilation defect

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

    Time frame: Baseline

  2. Pulmonary function - airflow limitation

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

    Time frame: Baseline

  3. Pulmonary function - lung volumes

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

    Time frame: Baseline

  4. Pulmonary function - diffusion lung capacity

    DLCO will be performed according to the American Thoracic Society guidelines

    Time frame: Baseline

  5. Pulmonary function - ventilation homogeneity

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

    Time frame: Baseline

Other outcomes

  1. Inflammatory and oxidative stress markers

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

    Time frame: Baseline

  2. Pneumoproteins SP-D

    Surfactant protein D (plasma)

    Time frame: Baseline

  3. Pneumoproteins CCSP-16

    CCSP-16 (plasma)

    Time frame: Baseline

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 10, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02820818
Lead sponsor
St. Justine's Hospital
Responsible party
Thuy Mai Luu (Clinical associate professor of pediatrics, St. Justine's Hospital) — Principal investigator
First posted
Jul 1, 2016
Start date
Jun 2016
Primary completion
Apr 2017
Completion
Dec 2021
Last update
Apr 10, 2024

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion