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Pulmonary Outcomes of Bronchopulmonary Dysplasia in Young Adulthood

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ClinicalTrials.gov Identifier: NCT02820818
Recruitment Status : Active, not recruiting
First Posted : July 1, 2016
Last Update Posted : September 5, 2018
Sponsor:
Information provided by (Responsible Party):
Thuy Mai Luu, St. Justine's Hospital

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.

Condition or disease
Premature Birth Obstructive Lung Disease Bronchopulmonary Dysplasia

Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Bronchopulmonary Dysplasia: From Neonatal Chronic Lung Disease to Early Onset Adult COPD
Actual Study Start Date : June 2016
Actual Primary Completion Date : April 2017
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Diseases




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Ventilation defect [ Time Frame: Baseline ]
    Thoracic hyperpolarized 129Xe MRI to measure apparent diffusion coefficient (ADC) - subgroup of 10 participants (5 preterm, 5 control)

  2. Pulmonary function - airflow limitation [ Time Frame: Baseline ]
    Spirometry (FEV1/FVC) will be performed according to the American Thoracic Society guidelines

  3. Pulmonary function - lung volumes [ Time Frame: Baseline ]
    Lung volumes (RV/TLC) by plethysmography will be performed according to the American Thoracic Society guidelines

  4. Pulmonary function - diffusion lung capacity [ Time Frame: Baseline ]
    DLCO will be performed according to the American Thoracic Society guidelines

  5. Pulmonary function - ventilation homogeneity [ Time Frame: Baseline ]
    Lung clearance index by nitrogen washout will be performed according to the American Thoracic Society guidelines


Other Outcome Measures:
  1. Inflammatory and oxidative stress markers [ Time Frame: Baseline ]
    Oxidative stress markers glutathione (GSH, GSSG; by capillary zone Electrophoresis) with calculation of Redox potential by the Nernst equation

  2. Pneumoproteins SP-D [ Time Frame: Baseline ]
    Surfactant protein D (plasma)

  3. Pneumoproteins CCSP-16 [ Time Frame: Baseline ]
    CCSP-16 (plasma)


Biospecimen Retention:   Samples With DNA
Nasal epithelial cells, whole blood


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Ages Eligible for Study:   20 Years to 29 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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).
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

Responsible Party: Thuy Mai Luu, Clinical associate professor of pediatrics, St. Justine's Hospital
ClinicalTrials.gov Identifier: NCT02820818     History of Changes
Other Study ID Numbers: 247649
First Posted: July 1, 2016    Key Record Dates
Last Update Posted: September 5, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Thuy Mai Luu, St. Justine's Hospital:
thoracic magnetic resonance imaging
pulmonary function test

Additional relevant MeSH terms:
Lung Diseases
Bronchopulmonary Dysplasia
Premature Birth
Lung Diseases, Obstructive
Respiratory Tract Diseases
Ventilator-Induced Lung Injury
Lung Injury
Infant, Premature, Diseases
Infant, Newborn, Diseases
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications