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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02820818
Other study ID # 247649
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 2016
Est. completion date December 2021

Study information

Verified date April 2024
Source St. Justine's Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date December 2021
Est. primary completion date April 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 29 Years
Eligibility 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 Design


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
St. Justine's Hospital

Outcome

Type Measure Description Time frame Safety issue
Other Inflammatory and oxidative stress markers Oxidative stress markers glutathione (GSH, GSSG; by capillary zone Electrophoresis) with calculation of Redox potential by the Nernst equation Baseline
Other Pneumoproteins SP-D Surfactant protein D (plasma) Baseline
Other Pneumoproteins CCSP-16 CCSP-16 (plasma) Baseline
Primary 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. Baseline
Secondary Ventilation defect Thoracic hyperpolarized 129Xe MRI to measure apparent diffusion coefficient (ADC) - subgroup of 10 participants (5 preterm, 5 control) Baseline
Secondary Pulmonary function - airflow limitation Spirometry (FEV1/FVC) will be performed according to the American Thoracic Society guidelines Baseline
Secondary Pulmonary function - lung volumes Lung volumes (RV/TLC) by plethysmography will be performed according to the American Thoracic Society guidelines Baseline
Secondary Pulmonary function - diffusion lung capacity DLCO will be performed according to the American Thoracic Society guidelines Baseline
Secondary Pulmonary function - ventilation homogeneity Lung clearance index by nitrogen washout will be performed according to the American Thoracic Society guidelines Baseline
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