Actively Recruiting

Age: 35Weeks - 21Months
All Genders
NCT06065215

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

Led by Children's Hospital of Eastern Ontario · Updated on 2025-02-24

319

Participants Needed

4

Research Sites

169 weeks

Total Duration

On this page

Sponsors

C

Children's Hospital of Eastern Ontario

Lead Sponsor

T

The Hospital for Sick Children

Collaborating Sponsor

AI-Summary

What this Trial Is About

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 than 29 weeks gestation will be recruited from 4 centres, including 5 babies who received stem cell therapy in a clinical trial. Babies will be evaluated at 36 weeks post-conception with lung MRI, oscillometry (lung function), echocardiogram (heart ultrasound), and oscillometry. Lung health will be assessed every 3 months by phone questionnaire and chart review. At 18-21 months post-conception, babies will undergo neurodevelopmental assessment and lung function testing. The investigators will look at how well baseline MRI markers predict subsequent lung health and development, independently and combined with echocardiogram, lung ultrasound, and traditional markers of BPD. The investigators anticipate that these new MRI markers will measure lung health safely and longitudinally in babies born extremely preterm. By identifying predictors of longer-term lung disease, clinicians will be able to allocate resources to babies at the highest risk of severe disease. Further, The investigators envision that MRI will help identify babies who would benefit most from interventions like stem cell therapy and be useful for evaluation of future treatments.

CONDITIONS

Official Title

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

Who Can Participate

Age: 35Weeks - 21Months
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Infants born before 29 weeks gestation
  • Currently younger than 36 weeks post-menstrual age (PMA)
Not Eligible

You will not qualify if you...

  • Known interstitial lung disease, congenital lung anomaly, ciliary dysfunction, immunodeficiency, cystic fibrosis, neuromuscular disease, or structural heart disease (except minor defects like atrial septal defect, hemodynamically insignificant ventricular septal defect, or 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 unable to speak English or French
  • Transferred to another hospital before baseline study visit
  • Not receiving follow-up at one of the study centres

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 4 locations

1

The Children's Hospital of Eastern Ontario

Ottawa, Ontario, Canada, K1H 8L1

Actively Recruiting

2

Mount Sinai Hospital

Toronto, Ontario, Canada, M5G 1X5

Actively Recruiting

3

CHU-Sainte Justine

Montreal, Quebec, Canada, H3T 1C5

Active, Not Recruiting

4

Montreal Children's Hospital

Montreal, Quebec, Canada, H4A 3J1

Actively Recruiting

Loading map...

Research Team

S

Sherri Katz

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

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