Identifying early MRI markers for lung issues in extremely preterm infants
Official title: Early-life MRI Biomarkers of Longer-term Respiratory Morbidity in Infants Born Extremely Preterm (EMBLEM)
Run by Children's Hospital of Eastern Ontario · NCT06065215 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 35 Weeks to 21 Months |
| Sex | All |
| Enrollment | 319 (estimated) |
| Sponsor | Children's Hospital of Eastern Ontario Academic / other |
| Locations | 4 sites (Ottawa, Ontario and 3 other locations) |
| Status | Recruiting |
| Started | March 30, 2024 |
| Main results expected | June 30, 2027 |
| Study ends | June 30, 2027 |
| Registry record updated | February 24, 2025 |
| Trial ID | NCT06065215 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are infants born at less than 29 weeks gestation who are currently under 36 weeks postmenstrual age.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
The Children's Hospital of Eastern Ontario
Ottawa, Ontario, Canada Recruiting -
Mount Sinai Hospital
Toronto, Ontario, Canada Recruiting -
Montreal Children's Hospital
Montreal, Quebec, Canada Recruiting -
CHU-Sainte Justine
Montreal, Quebec, Canada Active not 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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Higher zinc supplementation to boost weight gain in extremely premature infants
This study tests whether giving preterm babies a higher daily dose of zinc helps them gain weight faster than the current dose.
-
Remote-controlled oxygen therapy for preterm infants with BPD
This project will test whether remote monitoring and protocol-driven adjustments of home oxygen can safely help preterm infants with bronchopulmonary dysplasia stop oxygen sooner.
-
Cost Effective Air Filtration for Kids’ Asthma in NYC Housing
Aiming to see if a cost-effective HEPA air cleaner used in homes of children with asthma in NYC can lower indoor pollution and improve asthma symptoms.
-
Using stem cells from umbilical cords to treat lung disease in premature infants
This study is testing whether using stem cells from umbilical cords can help improve lung health in premature infants with a serious lung condition called bronchopulmonary dysplasia.
-
Evaluating L-Citrulline for Preterm Infants with Lung and Gut Issues
This study is testing if giving L-Citrulline to preterm infants with lung and gut problems can help reduce inflammation and improve their health.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.