Lung FunctionEMBLEMNCT06065215
Early-life MRI Biomarkers of Longer-term Respiratory Morbidity in Infants Born Extremely Preterm (EMBLEM)
An observational study of Lung Function and BPD - Bronchopulmonary Dysplasia, run by Children's Hospital of Eastern Ontario at 4 sites in Canada.
Trial summary
Bronchopulmonary dysplasia (BPD) is a common, major complication of premature birth, associated with developmental and health consequences that continue into adulthood. Prediction of who will have these problems is challenging using traditional definitions of disease. Read more about this study
- Who is it for?
- Ages 35 weeks to 21 months
- Conditions the study is for
- Lung Function, BPD - Bronchopulmonary Dysplasia
- What is being tested?
- Magnetic Resonance Imaging (MRI), Echocardiogram and Lung ultrasound
- How many people
- 319 participants
- Where
- 4 sitesCanada
- Study dates
- 30 Mar 2024to 30 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 35 weeks to 21 months
- All sexes
- No healthy volunteers
- Child
Study population: Babies will be recruited from four Canadian tertiary care pediatric centers: Children's Hospital of Eastern Ontario (CHEO), Ottawa, ON; Mount Sinai Hospital, Toronto, ON; Centre Hospitalier Universitaire Sainte-Justine, Montreal QC; and Montreal Children's Hospital, Montreal QC. MRI will occur at each site except Mount Sinai, whose babies will undergo MRI at The Hospital for Sick Children, Toronto, ON.
Who may be able to join
- Infants born at <29 weeks gestation;
- currently <36 weeks PMA.
Who cannot join
- Known interstitial lung disease, congenital lung anomaly, ciliary dysfunction, immunodeficiency, cystic fibrosis, neuromuscular disease, or structural heart disease (other than atrial septal defect/hemodynamically insignificant ventricular septal defect/patent ductus arteriosus);
- genetic syndrome or congenital anomaly;
- contraindications for MRI or transport;
- invasive or non-invasive ventilation that cannot be safely removed for MRI;
- current respiratory infection;
- family cannot speak English/French;
- transferred to another hospital prior to baseline study visit
- not receiving follow-up at one of the study centres.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada4 sites, 3 recruiting
- Active, not recruiting
CHU-Sainte Justine
Montreal, Quebec, H3T 1C5
- Recruiting
Montreal Children's Hospital
Montreal, Quebec, H4A 3J1
Gabriel Altit, Co-Site Lead, gabriel.altit@mcgill.ca
Larry Lands, Co-Site Lead, larry.lands@mcgill.ca
- Recruiting
The Children's Hospital of Eastern Ontario
Ottawa, Ontario, K1H 8L1
Sherri Katz, Clinical Study Lead, (613) 737-7600 ext. 2956, skatz@cheo.on.ca
- Recruiting
Mount Sinai Hospital
Toronto, Ontario, M5G 1X5
Adel Mohamed, Site Lead, 416-586-4800 ext. 7396, adel.mohamed@sinaihealth.ca
About this study
Bronchopulmonary dysplasia (BPD) is a common, major complication of premature birth, associated with developmental and health consequences that continue into adulthood. Prediction of who will have these problems is challenging using traditional definitions of disease. It is believed that underdevelopment and injury occur in both lung tissue and the blood vessels in the lungs, with a sophisticated interplay between them that contributes to lung disease seen in prematurity. New magnetic resonance imaging (MRI) techniques can delineate tissue structure with unprecedented granularity, assessing lung tissue, blood vessels, and their interplay. The ability to identify, at an early stage, those infants destined for chronic lung disease with greater certainty will be useful in counseling families and critical for the effective introduction of promising new BPD therapies. 319 infants born less than 29 weeks gestation will be recruited from 4 centres, including 5 babies who received stem cell therapy in a clinical trial. Babies will be evaluated at 36 weeks post-conception with lung MRI, oscillometry (lung function), echocardiogram (heart ultrasound), and oscillometry. Lung health will be assessed every 3 months by phone questionnaire and chart review. At 18-21 months post-conception, babies will undergo neurodevelopmental assessment and lung function testing. The investigators will look at how well baseline MRI markers predict subsequent lung health and development, independently and combined with echocardiogram, lung ultrasound, and traditional markers of BPD. The investigators anticipate that these new MRI markers will measure lung health safely and longitudinally in babies born extremely preterm. By identifying predictors of longer-term lung disease, clinicians will be able to allocate resources to babies at the highest risk of severe disease. Further, The investigators envision that MRI will help identify babies who would benefit most from interventions like stem cell therapy and be useful for evaluation of future treatments.
- Conditions
- Lung Function, BPD - Bronchopulmonary Dysplasia
- Being tested
- Magnetic Resonance Imaging (MRI), Echocardiogram, Lung ultrasound
- Medical subject headings
- Bronchopulmonary Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance Imaging (MRI)Diagnostic test
Magnetic Resonance Imaging (MRI) is a non-invasive medical imaging technique that uses powerful magnets and radio waves to generate detailed images of the body's internal structures. The MRI intervention includes using a specialized MRI machine and lung imaging protocol.
EchocardiogramDiagnostic test
An echocardiogram, often called an "echo," is a non-invasive medical test that uses high-frequency sound waves (ultrasound) to create real-time images of the heart's structure and function. It provides valuable information about the heart's size, shape, and function.
Lung ultrasoundDiagnostic test
Lung ultrasound is a non-invasive imaging technique that employs high-frequency sound waves (ultrasound) to visualize the structures and conditions of the lungs. It is particularly valuable for diagnosing and monitoring lung-related conditions, such as pneumonia, pleural effusions, and pulmonary edema. The lung ultrasound intervention involves using an ultrasound machine equipped with a specialized probe gently placed on the chest to capture detailed images of the lungs and adjacent structures.
What is being measured
The primary outcome is the main question the study is designed to answer.
Severe Post-prematurity Respiratory Disease (PRD)
PRD will be defined based on the consensus definition of the Prematurity and Respiratory Outcomes Program. This composite outcome characterizes clinically relevant persistent respiratory morbidity in early life. It will be evaluated every 3 months from 36 weeks PMA to 18 months corrected age through parent questionnaire and chart review. Severe PRD is defined as a positive response to any of the following: ≥2 respiratory-related hospitalizations, home oxygen at 3 months corrected age or any home respiratory support, systemic corticosteroid or pulmonary vasodilators after discharge home, chronic respiratory symptoms (cough without cold or wheeze at least once per week) despite concurrent inhaled corticosteroids in ≥ 2 questionnaires, or death secondary to a cardiopulmonary cause. PRD has been used as a clinical outcome in cohort studies and an American Thoracic Society guideline on optimal neonatal care pathways and predictive perinatal characteristics.
Measured: The evaluation will be conducted at regular intervals of every 3 months, commencing at 36 weeks PMA and continuing until the child reaches 18 months corrected age
Secondary outcomes (1)
Neurodevelopmental Impairment (NDI)
Per the Canadian Neonatal Follow-Up Network protocol, NDI will be determined at the 18-21 months corrected age visit. Children will be administered the Bayley Scales of Infant and Toddler Development, 4th edition (Bayley-4), assessing infant developmental functioning across five domains. Cognition, language, and motor subtests are directly assessed by a blinded, trained assessor regarding neonatal history. The social-emotional and adaptive behavior components are assessed via parental questionnaires. The Bayley-4 yields standard mean scores of 100±15. A pediatrician performs a neurological examination to identify signs of cerebral palsy and determine functional level using the Gross Motor Functional Classification System (GMFCS). Visual and hearing function data are retrieved from the chart. NDI will be defined as the presence of any of the following: Bayley-4 score <85, cerebral palsy with GMFCS ≥ 2, the requirement for hearing aids/cochlear implants, and bilateral blindness.
Measured: Neurodevelopmental impairment will be determined at the 18-21 months corrected age visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2023
- Study start30 Mar 2024
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung FunctionStudies 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
- Prospective
- Enrolment
- 319 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Eastern Ontario
- Sponsor type
- University, hospital or other
- Collaborators
- The Hospital for Sick Children, MOUNT SINAI HOSPITAL, Hannover Medical School, St. Justine's Hospital, Montreal Children's Hospital of the MUHC
- Responsible party
- Principal investigator, Sherri Katz, Children's Hospital of Eastern Ontario
- Investigators
- Sherri Katz, Principal investigator, Children's Hospital of Eastern Ontario
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06065215
- Sponsor's protocol ID
- 486713
- Acronym
- EMBLEM
- Status last verified
- Feb 2025
- First submitted
- 27 Sep 2023
- Last updated
- 24 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early-life MRI Biomarkers of Longer-term Respiratory Morbidity in Infants Born Extremely Preterm (EMBLEM)
- ClinicalTrials.gov ID
- NCT06065215
- Acronym / sponsor ID
- EMBLEM / 486713
- Conditions
- Lung Function, BPD - Bronchopulmonary Dysplasia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 319 participants (estimated)
- Lead sponsor
- Children's Hospital of Eastern OntarioUniversity, hospital or other
- Collaborators
- The Hospital for Sick Children, MOUNT SINAI HOSPITAL, Hannover Medical School, St. Justine's Hospital, Montreal Children's Hospital of the MUHC
- Study start
- 30 Mar 2024 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 3 Oct 2023 (actual)
- 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.
Bronchopulmonary dysplasia (BPD) is a common, major complication of premature birth, associated with developmental and health consequences that continue into adulthood. Prediction of who will have these problems is challenging using traditional definitions of disease. It is believed that underdevelopment and injury occur in both lung tissue and the blood vessels in the lungs, with a sophisticated interplay between them that contributes to lung disease seen in prematurity. New magnetic resonance imaging (MRI) techniques can delineate tissue structure with unprecedented granularity, assessing lung tissue, blood vessels, and their interplay. The ability to identify, at an early stage, those infants destined for chronic lung disease with greater certainty will be useful in counseling families and critical for the effective introduction of promising new BPD therapies. 319 infants born less than 29 weeks gestation will be recruited from 4 centres, including 5 babies who received stem cell therapy in a clinical trial. Babies will be evaluated at 36 weeks post-conception with lung MRI, oscillometry (lung function), echocardiogram (heart ultrasound), and oscillometry. Lung health will be assessed every 3 months by phone questionnaire and chart review. At 18-21 months post-conception, babies will undergo neurodevelopmental assessment and lung function testing. The investigators will look at how well baseline MRI markers predict subsequent lung health and development, independently and combined with echocardiogram, lung ultrasound, and traditional markers of BPD. The investigators anticipate that these new MRI markers will measure lung health safely and longitudinally in babies born extremely preterm. By identifying predictors of longer-term lung disease, clinicians will be able to allocate resources to babies at the highest risk of severe disease. Further, The investigators envision that MRI will help identify babies who would benefit most from interventions like stem cell therapy and be useful for evaluation of future treatments.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 35 weeks to 21 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Babies will be recruited from four Canadian tertiary care pediatric centers: Children's Hospital of Eastern Ontario (CHEO), Ottawa, ON; Mount Sinai Hospital, Toronto, ON; Centre Hospitalier Universitaire Sainte-Justine, Montreal QC; and Montreal Children's Hospital, Montreal QC. MRI will occur at each site except Mount Sinai, whose babies will undergo MRI at The Hospital for Sick Children, Toronto, ON.
Key inclusion criteria (2 listed)
- Infants born at <29 weeks gestation;
- currently <36 weeks PMA.
Key exclusion criteria (8 listed)
- Known interstitial lung disease, congenital lung anomaly, ciliary dysfunction, immunodeficiency, cystic fibrosis, neuromuscular disease, or structural heart disease (other than atrial septal defect/hemodynamically insignificant ventricular septal defect/patent ductus arteriosus);
- genetic syndrome or congenital anomaly;
- contraindications for MRI or transport;
- invasive or non-invasive ventilation that cannot be safely removed for MRI;
- current respiratory infection;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnetic Resonance Imaging (MRI)Magnetic Resonance Imaging (MRI) is a non-invasive medical imaging technique that uses powerful magnets and radio waves to generate detailed images of the body's internal structures. The MRI intervention includes using a specialized MRI machine and lung imaging protocol. | Diagnostic test | – |
| EchocardiogramAn echocardiogram, often called an "echo," is a non-invasive medical test that uses high-frequency sound waves (ultrasound) to create real-time images of the heart's structure and function. It provides valuable information about the heart's size, shape, and function. | Diagnostic test | – |
| Lung ultrasoundLung ultrasound is a non-invasive imaging technique that employs high-frequency sound waves (ultrasound) to visualize the structures and conditions of the lungs. It is particularly valuable for diagnosing and monitoring lung-related conditions, such as pneumonia, pleural effusions, and pulmonary edema. The lung ultrasound intervention involves using an ultrasound machine equipped with a specialized probe gently placed on the chest to capture detailed images of the lungs and adjacent structures. | Diagnostic test | – |
Primary outcome
Severe Post-prematurity Respiratory Disease (PRD)
Time frame: The evaluation will be conducted at regular intervals of every 3 months, commencing at 36 weeks PMA and continuing until the child reaches 18 months corrected age
PRD will be defined based on the consensus definition of the Prematurity and Respiratory Outcomes Program. This composite outcome characterizes clinically relevant persistent respiratory morbidity in early life. It will be evaluated every 3 months from 36 weeks PMA to 18 months corrected age through parent questionnaire and chart review. Severe PRD is defined as a positive response to any of the following: ≥2 respiratory-related hospitalizations, home oxygen at 3 months corrected age or any home respiratory support, systemic corticosteroid or pulmonary vasodilators after discharge home, chronic respiratory symptoms (cough without cold or wheeze at least once per week) despite concurrent inhaled corticosteroids in ≥ 2 questionnaires, or death secondary to a cardiopulmonary cause. PRD has been used as a clinical outcome in cohort studies and an American Thoracic Society guideline on optimal neonatal care pathways and predictive perinatal characteristics.
1 secondary outcome
Neurodevelopmental Impairment (NDI)
Time frame: Neurodevelopmental impairment will be determined at the 18-21 months corrected age visit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2025.
- 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.
Sherri Katz principal investigator
Children's Hospital of Eastern Ontario
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Function and BPD - Bronchopulmonary Dysplasia, run by Children's Hospital of Eastern Ontario at 4 sites in Canada.
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 2 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 24 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sherri Katz ((613) 737-7600, skatz@cheo.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severe Post-prematurity Respiratory Disease (PRD) (time frame: The evaluation will be conducted at regular intervals of every 3 months, commencing at 36 weeks PMA and continuing until the child reaches 18 months corrected age). 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 24 Feb 2025.