Identifying early MRI markers for lung issues in extremely preterm infants
Early-life MRI Biomarkers of Longer-term Respiratory Morbidity in Infants Born Extremely Preterm (EMBLEM)
This study is testing if early MRI scans can help predict lung problems in extremely preterm infants to improve their care and treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 319 (estimated) |
| Ages | 35 Weeks to 21 Months |
| Sex | All |
| Sponsor | Children's Hospital of Eastern Ontario Academic / other |
| Locations | 4 sites (Ottawa, Ontario and 3 other locations) |
| Trial ID | NCT06065215 on ClinicalTrials.gov |
What this trial studies
This observational study aims to identify early-life MRI biomarkers that can predict longer-term respiratory morbidity in infants born extremely preterm, specifically those under 29 weeks gestation. By utilizing advanced MRI techniques, the study will assess lung tissue and blood vessel development to better understand the risk of bronchopulmonary dysplasia (BPD). A total of 319 infants will be recruited from four centers, and their lung function will be monitored to improve early diagnosis and treatment strategies. The findings could enhance family counseling and the introduction of new therapies for BPD.
Who should consider this trial
Good fit: Ideal candidates for this study are infants born at less than 29 weeks gestation who are currently under 36 weeks postmenstrual age.
Not a fit: Patients with known lung diseases, congenital anomalies, or those requiring invasive ventilation that cannot be safely removed for MRI will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved early identification of infants at risk for chronic lung disease, allowing for timely interventions.
How similar studies have performed: While the approach of using MRI to assess lung development in preterm infants is innovative, similar studies have shown promise in identifying early biomarkers for respiratory conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Ottawa, Ontario and 3 other locations
- The Children's Hospital of Eastern Ontario — Ottawa, Ontario, Canada (Recruiting)
- Mount Sinai Hospital — Toronto, Ontario, Canada (Recruiting)
- CHU-Sainte Justine — Montreal, Quebec, Canada (Active_not_recruiting)
- Montreal Children's Hospital — Montreal, Quebec, Canada (Recruiting)
Study contacts
- Principal investigator: Sherri Katz — Children's Hospital of Eastern Ontario
- Study coordinator: Sherri Katz
- Email: skatz@cheo.on.ca
- Phone: (613) 737-7600
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.