Actively Recruiting
Early-life MRI Biomarkers of Longer-term Respiratory Morbidity in Infants Born Extremely Preterm (EMBLEM)
Led by Children's Hospital of Eastern Ontario · Updated on 2025-02-24
319
Participants Needed
4
Research Sites
N/A
Total Duration
On this page
Sponsors
C
Children's Hospital of Eastern Ontario
Lead Sponsor
T
The Hospital for Sick Children
Collaborating Sponsor
AI-Summary
What this Trial Is About
Bronchopulmonary dysplasia (BPD) is a common and serious complication affecting babies born very prematurely, with effects that can continue into adulthood. This research aims to improve early identification of infants at risk for long-term lung problems by using advanced MRI techniques that provide detailed images of lung tissue and blood vessels. These new imaging methods may help predict which infants will develop chronic lung disease and guide future treatments like stem cell therapy. The study involves recruiting 319 infants born before 29 weeks of gestation from four centers. At 36 weeks post-menstrual age, participants will undergo lung MRI, lung function testing with oscillometry, heart ultrasound (echocardiogram), and lung ultrasound. Follow-up assessments of lung health will be conducted every three months via phone questionnaires and medical record reviews. At 18 to 21 months corrected age, infants will receive neurodevelopmental evaluations and lung function tests to assess their progress. Participants will be monitored regularly from 36 weeks post-menstrual age until 18 months corrected age. The research team will evaluate how well early MRI markers predict later lung health and developmental outcomes, alongside other tests and traditional BPD markers. This long-term observation will help identify infants at highest risk for severe lung disease and support the development of targeted therapies. The total involvement lasts approximately up to 21 months of corrected age.
CONDITIONS
Brief Title
Early-life MRI Biomarkers of Longer-term Respiratory Morbidity in Infants Born Extremely Preterm (EMBLEM)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Infants born before 29 weeks gestation
- Currently less than 36 weeks post-menstrual age
You will not qualify if you...
- Known interstitial lung disease, congenital lung anomaly, ciliary dysfunction, immunodeficiency, cystic fibrosis, neuromuscular disease, or significant structural heart disease except minor defects
- 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 unable to speak English or French
- Transferred to another hospital prior to baseline study visit
- Not receiving follow-up at one of the study centres
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Initial assessments conducted at baseline
Participants undergo imaging tests including MRI, echocardiogram, and lung ultrasound to assess lung and heart conditions.
1 to 2 visits depending on imaging schedules
Duration - From 36 weeks post-menstrual age to 18-21 months corrected age
Participants are monitored regularly for respiratory health and neurodevelopmental outcomes until 18 to 21 months corrected age.
Visits every 3 months until 18 months corrected age, plus 1 visit at 18-21 months corrected age
Trial Site Locations
Total: 4 locations
1
The Children's Hospital of Eastern Ontario
Ottawa, Ontario, Canada, K1H 8L1
Actively Recruiting
2
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G 1X5
Actively Recruiting
3
CHU-Sainte Justine
Montreal, Quebec, Canada, H3T 1C5
Active, Not Recruiting
4
Montreal Children's Hospital
Montreal, Quebec, Canada, H4A 3J1
Actively Recruiting
Research Team
S
Sherri Katz
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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