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

Recruitingn/aAges 35 Weeks - 21 MonthsAllChildren's Hospital of Eastern Ontario
NCT06065215 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 th

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📋 Eligibility rules (as published)
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.
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What it tests

  • Magnetic Resonance Imaging (MRI)
  • Echocardiogram
  • Lung ultrasound
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Where

4 sites
The Children's Hospital of Eastern Ontario
Ottawa, Canada
Mount Sinai Hospital
Toronto, Canada
CHU-Sainte Justine
Montreal, Canada
Montreal Children's Hospital
Montreal, Canada
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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