Pulmonary Outcomes of Bronchopulmonary Dysplasia in Young Adulthood

Premature Birth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02820818
• Other study ID #: 247649
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Bronchopulmonary Dysplasia
• Lung Diseases
• Lung Diseases, Obstructive
• Obstructive Lung Disease
• Premature Birth

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