Status:
RECRUITING
Early-life MRI Biomarkers of Longer-term Respiratory Morbidity in Infants Born Extremely Preterm (EMBLEM)
Lead Sponsor:
Children's Hospital of Eastern Ontario
Collaborating Sponsors:
The Hospital for Sick Children
MOUNT SINAI HOSPITAL
Conditions:
Lung Function
BPD - Bronchopulmonary Dysplasia
Eligibility:
All Genders
35-21 years
Brief 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 the...
Eligibility Criteria
Inclusion
- Infants born at \<29 weeks gestation;
- currently \<36 weeks PMA.
Exclusion
- 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.
Key Trial Info
Start Date :
March 30 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 30 2027
Estimated Enrollment :
319 Patients enrolled
Trial Details
Trial ID
NCT06065215
Start Date
March 30 2024
End Date
June 30 2027
Last Update
February 24 2025
Active Locations (4)
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1
The Children's Hospital of Eastern Ontario
Ottawa, Ontario, Canada, K1H 8L1
2
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G 1X5
3
CHU-Sainte Justine
Montreal, Quebec, Canada, H3T 1C5
4
Montreal Children's Hospital
Montreal, Quebec, Canada, H4A 3J1