Premature BirthNCT02820818
Pulmonary Outcomes of Bronchopulmonary Dysplasia in Young Adulthood
An observational study of Premature Birth and Obstructive Lung Disease, run by St. Justine's Hospital.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 29 yearsHealthy volunteers can take part
- Conditions the study is for
- Premature Birth, Obstructive Lung Disease, Bronchopulmonary Dysplasia
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Jun 2016to Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 29 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: 25 adults aged 20-29 born preterm (<29 weeks); 25 sex and age-matched controls (friend or sibling).
Who may be able to join
- 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)
Who cannot join
- 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
About this study
Official title: 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.
- Keywords
- thoracic magnetic resonance imaging, pulmonary function test
- Medical subject headings
- Premature Birth, Lung Diseases, Obstructive, Bronchopulmonary Dysplasia
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Secondary outcomes (5)
Ventilation defect
Thoracic hyperpolarized 129Xe MRI to measure apparent diffusion coefficient (ADC) - subgroup of 10 participants (5 preterm, 5 control)
Measured: Baseline
Pulmonary function - airflow limitation
Spirometry (FEV1/FVC) will be performed according to the American Thoracic Society guidelines
Measured: Baseline
Pulmonary function - lung volumes
Lung volumes (RV/TLC) by plethysmography will be performed according to the American Thoracic Society guidelines
Measured: Baseline
Pulmonary function - diffusion lung capacity
DLCO will be performed according to the American Thoracic Society guidelines
Measured: Baseline
Pulmonary function - ventilation homogeneity
Lung clearance index by nitrogen washout will be performed according to the American Thoracic Society guidelines
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2016 (estimated)
- Study startJun 2016
- Primary completionApr 2017
- Study completionDec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature BirthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Justine's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thuy Mai Luu, St. Justine's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02820818
- Sponsor's protocol ID
- 247649
- Status last verified
- Apr 2024
- First submitted
- 29 Jun 2016
- Last updated
- 10 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bronchopulmonary Dysplasia: From Neonatal Chronic Lung Disease to Early Onset Adult COPD
- ClinicalTrials.gov ID
- NCT02820818
- Acronym / sponsor ID
- 247649
- Keywords
- thoracic magnetic resonance imaging, pulmonary function test
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- St. Justine's HospitalUniversity, hospital or other
- Study start
- Jun 2016 (actual)
- Primary completion
- Apr 2017 (actual)
- Study completion
- Dec 2021 (actual)
- First posted
- 1 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 20 to 29 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 25 adults aged 20-29 born preterm (<29 weeks); 25 sex and age-matched controls (friend or sibling).
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
5 secondary outcomes
Ventilation defect
Time frame: Baseline
Pulmonary function - airflow limitation
Time frame: Baseline
Pulmonary function - lung volumes
Time frame: Baseline
Pulmonary function - diffusion lung capacity
Time frame: Baseline
Pulmonary function - ventilation homogeneity
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Premature Birth and Obstructive Lung Disease, run by St. Justine's Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lung parenchymal tissue density (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2024.