Skip to main content
Clinical Trials/NCT02820818
NCT02820818
Completed
Not Applicable

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

St. Justine's Hospital0 sites50 target enrollmentJune 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Premature Birth
Sponsor
St. Justine's Hospital
Enrollment
50
Primary Endpoint
Lung parenchymal tissue density
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 2016
End Date
December 2021
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
St. Justine's Hospital
Responsible Party
Principal Investigator
Principal Investigator

Thuy Mai Luu

Clinical associate professor of pediatrics

St. Justine's Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Pulmonary function - airflow limitation(Baseline)
  • Pulmonary function - lung volumes(Baseline)
  • Pulmonary function - diffusion lung capacity(Baseline)
  • Ventilation defect(Baseline)
  • Pulmonary function - ventilation homogeneity(Baseline)

Similar Trials