Ignite Creation Date:
2025-12-25 @ 4:54 AM
Ignite Modification Date:
2026-02-01 @ 3:42 AM
Study NCT ID:
NCT02820818
Status:
COMPLETED
Last Update Posted:
2024-04-10
First Post:
2016-06-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pulmonary Outcomes of Bronchopulmonary Dysplasia in Young Adulthood
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D047928', 'term': 'Premature Birth'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D001997', 'term': 'Bronchopulmonary Dysplasia'}], 'ancestors': [{'id': 'D007752', 'term': 'Obstetric Labor, Premature'}, {'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D055397', 'term': 'Ventilator-Induced Lung Injury'}, {'id': 'D055370', 'term': 'Lung Injury'}, {'id': 'D007235', 'term': 'Infant, Premature, Diseases'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Nasal epithelial cells, whole blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2021-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-08', 'studyFirstSubmitDate': '2016-06-29', 'studyFirstSubmitQcDate': '2016-06-29', 'lastUpdatePostDateStruct': {'date': '2024-04-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-07-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Inflammatory and oxidative stress markers', 'timeFrame': 'Baseline', 'description': 'Oxidative stress markers glutathione (GSH, GSSG; by capillary zone Electrophoresis) with calculation of Redox potential by the Nernst equation'}, {'measure': 'Pneumoproteins SP-D', 'timeFrame': 'Baseline', 'description': 'Surfactant protein D (plasma)'}, {'measure': 'Pneumoproteins CCSP-16', 'timeFrame': 'Baseline', 'description': 'CCSP-16 (plasma)'}], 'primaryOutcomes': [{'measure': 'Lung parenchymal tissue density', 'timeFrame': 'Baseline', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Ventilation defect', 'timeFrame': 'Baseline', 'description': 'Thoracic hyperpolarized 129Xe MRI to measure apparent diffusion coefficient (ADC) - subgroup of 10 participants (5 preterm, 5 control)'}, {'measure': 'Pulmonary function - airflow limitation', 'timeFrame': 'Baseline', 'description': 'Spirometry (FEV1/FVC) will be performed according to the American Thoracic Society guidelines'}, {'measure': 'Pulmonary function - lung volumes', 'timeFrame': 'Baseline', 'description': 'Lung volumes (RV/TLC) by plethysmography will be performed according to the American Thoracic Society guidelines'}, {'measure': 'Pulmonary function - diffusion lung capacity', 'timeFrame': 'Baseline', 'description': 'DLCO will be performed according to the American Thoracic Society guidelines'}, {'measure': 'Pulmonary function - ventilation homogeneity', 'timeFrame': 'Baseline', 'description': 'Lung clearance index by nitrogen washout will be performed according to the American Thoracic Society guidelines'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['thoracic magnetic resonance imaging', 'pulmonary function test'], 'conditions': ['Premature Birth', 'Obstructive Lung Disease', 'Bronchopulmonary Dysplasia']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '29 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '25 adults aged 20-29 born preterm (\\<29 weeks); 25 sex and age-matched controls (friend or sibling).', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 20-29 years old\n* For the pre-term subject: \\<29 weeks gestational age, with or without BPD\n* For the matched term control: ≥37 weeks gestational age with birth weight appropriate for gestational age i.e. between the 10th and 90th percentile\n* Subject understands the study procedures and is willing to participate in the study as indicated by the signature on the informed consent\n* Subject is judged to be in otherwise stable health on the basis of medical history\n* 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)\n\nExclusion Criteria:\n\n* 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\n* Patient is unable to perform spirometry or plethysmography maneuvers\n* 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)\n* 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"}, 'identificationModule': {'nctId': 'NCT02820818', 'briefTitle': 'Pulmonary Outcomes of Bronchopulmonary Dysplasia in Young Adulthood', 'organization': {'class': 'OTHER', 'fullName': "St. Justine's Hospital"}, 'officialTitle': 'Bronchopulmonary Dysplasia: From Neonatal Chronic Lung Disease to Early Onset Adult COPD', 'orgStudyIdInfo': {'id': '247649'}}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "St. Justine's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical associate professor of pediatrics', 'investigatorFullName': 'Thuy Mai Luu', 'investigatorAffiliation': "St. Justine's Hospital"}}}}