Early-life MRI Biomarkers of Longer-term Respiratory Morbidity in Infants Born Extremely Preterm (EMBLEM)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

319 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-03-30

Study Completion Date

2027-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Pulmonary MRI of Ex-preterm Children With and Without BPD To Understand Risk of Emphysematous Changes

NCT02921308

Bronchopulmonary Dysplasia

COMPLETED

MRI of Lung Structure and Function in Preterm Children

NCT03475264

Bronchopulmonary Dysplasia

TERMINATED

MRI for Non-Invasive Imaging in Neonates and Children

NCT02163681

Healthy Cystic Fibrosis (CF) Asthma +1 more

COMPLETED NA

Analysis of Bronchial Remodeling Using Resonance Magnetic Imaging in Severe Asthmatic childrEn

NCT05419622

Asthma in Children

UNKNOWN NA

129Xe MRI in Pediatric Population With BPD

NCT04035629

Bronchopulmonary Dysplasia

NOT_YET_RECRUITING PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Lung Function BPD - Bronchopulmonary Dysplasia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DIAGNOSTIC_TEST

Echocardiogram

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.

Intervention Type DIAGNOSTIC_TEST

Lung ultrasound

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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Infants born at \<29 weeks gestation;
2. currently \<36 weeks PMA.

Exclusion Criteria

1. 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);
2. genetic syndrome or congenital anomaly;
3. contraindications for MRI or transport;
4. invasive or non-invasive ventilation that cannot be safely removed for MRI;
5. current respiratory infection;
6. family cannot speak English/French;
7. transferred to another hospital prior to baseline study visit
8. not receiving follow-up at one of the study centres.

Minimum Eligible Age

35 Weeks

Maximum Eligible Age

21 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No