- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02820818
Pulmonary Outcomes of Bronchopulmonary Dysplasia in Young Adulthood
May 12, 2022 updated by: Thuy Mai Luu, St. Justine's Hospital
Bronchopulmonary Dysplasia: From Neonatal Chronic Lung Disease to Early Onset Adult COPD
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.
Study Overview
Status
Active, not recruiting
Study Type
Observational
Enrollment (Anticipated)
50
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 29 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
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).
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Ventilation defect
Time Frame: Baseline
|
Thoracic hyperpolarized 129Xe MRI to measure apparent diffusion coefficient (ADC) - subgroup of 10 participants (5 preterm, 5 control)
|
Baseline
|
Pulmonary function - airflow limitation
Time Frame: Baseline
|
Spirometry (FEV1/FVC) will be performed according to the American Thoracic Society guidelines
|
Baseline
|
Pulmonary function - lung volumes
Time Frame: Baseline
|
Lung volumes (RV/TLC) by plethysmography will be performed according to the American Thoracic Society guidelines
|
Baseline
|
Pulmonary function - diffusion lung capacity
Time Frame: Baseline
|
DLCO will be performed according to the American Thoracic Society guidelines
|
Baseline
|
Pulmonary function - ventilation homogeneity
Time Frame: Baseline
|
Lung clearance index by nitrogen washout will be performed according to the American Thoracic Society guidelines
|
Baseline
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Baseline
|
Pneumoproteins SP-D
Time Frame: Baseline
|
Surfactant protein D (plasma)
|
Baseline
|
Pneumoproteins CCSP-16
Time Frame: Baseline
|
CCSP-16 (plasma)
|
Baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2016
Primary Completion (Actual)
April 1, 2017
Study Completion (Anticipated)
December 1, 2022
Study Registration Dates
First Submitted
June 29, 2016
First Submitted That Met QC Criteria
June 29, 2016
First Posted (Estimate)
July 1, 2016
Study Record Updates
Last Update Posted (Actual)
May 13, 2022
Last Update Submitted That Met QC Criteria
May 12, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 247649
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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