NCT06065215 Early-life MRI Biomarkers of Longer-term Respiratory Morbidity in Infants Born Extremely Preterm (EMBLEM)
| NCT ID | NCT06065215 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Children's Hospital of Eastern Ontario |
| Condition | Lung Function |
| Study Type | OBSERVATIONAL |
| Enrollment | 319 participants |
| Start Date | 2024-03-30 |
| Primary Completion | 2027-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 319 participants in total. It began in 2024-03-30 with a primary completion date of 2027-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Eligibility 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.
Contact & Investigator
Sherri Katz
PRINCIPAL INVESTIGATOR
Children's Hospital of Eastern Ontario
Frequently Asked Questions
Who can join the NCT06065215 clinical trial?
This trial is open to participants of all sexes, aged 35 Weeks or older, up to 21 Months, studying Lung Function. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06065215 currently recruiting?
Yes, NCT06065215 is actively recruiting participants. Contact the research team at skatz@cheo.on.ca for enrollment information.
Where is the NCT06065215 trial being conducted?
This trial is being conducted at Ottawa, Canada, Toronto, Canada, Montreal, Canada, Montreal, Canada.
Who is sponsoring the NCT06065215 clinical trial?
NCT06065215 is sponsored by Children's Hospital of Eastern Ontario. The principal investigator is Sherri Katz at Children's Hospital of Eastern Ontario. The trial plans to enroll 319 participants.