Clinical trial Recruiting at 3 sites Observational Ages 35 Weeks to 21 Months

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 typeObservational
Ages35 Weeks to 21 Months
SexAll
Enrollment319 (estimated)
SponsorChildren's Hospital of Eastern Ontario
Academic / other
Locations4 sites (Ottawa, Ontario and 3 other locations)
StatusRecruiting
StartedMarch 30, 2024
Main results expectedJune 30, 2027
Study endsJune 30, 2027
Registry record updatedFebruary 24, 2025
Trial IDNCT06065215 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.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.