Pulmonary Outcomes of Bronchopulmonary Dysplasia in Young Adulthood

NCT02820818 | Completed

• 1 other identifier: 247649
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Premature Birth; Obstructive Lung Disease; Bronchopulmonary Dysplasia

Keywords

thoracic magnetic resonance imaging; pulmonary function test

Outcome Measures

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.

  Baseline

Secondary Outcomes (5)

• Ventilation defect

  Baseline

• Pulmonary function - airflow limitation

  Baseline

• Pulmonary function - lung volumes

  Baseline

• Pulmonary function - diffusion lung capacity

  Baseline

• Pulmonary function - ventilation homogeneity

  Baseline

Other Outcomes (3)

• Inflammatory and oxidative stress markers

  Baseline

• Pneumoproteins SP-D

  Baseline

• Pneumoproteins CCSP-16

  Baseline

Eligibility Criteria

• Age: 20 Years - 29 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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).

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Justine's Hospital: lead

Biospecimen

Retention: SAMPLES WITH DNA

Nasal epithelial cells, whole blood

MeSH Terms

Conditions

Premature Birth; Lung Diseases, Obstructive; Bronchopulmonary Dysplasia

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Lung Diseases; Respiratory Tract Diseases; Ventilator-Induced Lung Injury; Lung Injury; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical associate professor of pediatrics

Study Record Dates

• First Submitted: June 29, 2016
• First Posted: July 1, 2016
• Study Start: June 1, 2016
• Primary Completion: April 1, 2017
• Study Completion: December 1, 2021
• Last Updated: April 10, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share