Pulmonary Outcomes of Bronchopulmonary Dysplasia in Young Adulthood

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
• Conditions: Premature Birth; Bronchopulmonary Dysplasia; Obstructive Lung Disease

• Study Type: Observational
• Enrollment (Anticipated): 50

Participation Criteria

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

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: St. Justine's Hospital

Study record dates

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

• Keywords: pulmonary function test; thoracic magnetic resonance imaging
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Infant, Newborn, Diseases; Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Lung Injury; Infant, Premature, Diseases; Ventilator-Induced Lung Injury; Lung Diseases; Lung Diseases, Obstructive; Premature Birth; Bronchopulmonary Dysplasia
• Other Study ID Numbers: 247649

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO