Recruiting

Observational Study

Sponsor:

Children's Hospital of Eastern Ontario

Code:

NCT06065215

Conditions

Lung Function

BPD - Bronchopulmonary Dysplasia

Eligibility Criteria

Sex: All

Age: 0 - 1

Healthy Volunteers: Not accepted

Interventions

Magnetic Resonance Imaging (MRI)

Echocardiogram

Lung ultrasound

Study Details

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.

Conditions

Lung Function

BPD - Bronchopulmonary Dysplasia

Study ID

NCT06065215

Start date

Mar 30, 2024

Status verified date

Feb, 2025

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 1

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

319 participants

Anticipated

Interventions and Outcome Measures

Interventions

Magnetic Resonance Imaging (MRI)

Magnetic Resonance Imaging (MRI) is a non-invasive medical imaging technique that uses powerful magnets and radio waves to generate detailed images of the body's internal structures. The MRI intervention includes using a specialized MRI machine and lung imaging protocol.

Echocardiogram

An echocardiogram, often called an "echo," is a non-invasive medical test that uses high-frequency sound waves (ultrasound) to create real-time images of the heart's structure and function. It provides valuable information about the heart's size, shape, and function.

Lung ultrasound

Lung ultrasound is a non-invasive imaging technique that employs high-frequency sound waves (ultrasound) to visualize the structures and conditions of the lungs. It is particularly valuable for diagnosing and monitoring lung-related conditions, such as pneumonia, pleural effusions, and pulmonary edema. The lung ultrasound intervention involves using an ultrasound machine equipped with a specialized probe gently placed on the chest to capture detailed images of the lungs and adjacent structures.

Primary outcome measure

  • Severe Post-prematurity Respiratory Disease (PRD) [ Time Frame: The evaluation will be conducted at regular intervals of every 3 months, commencing at 36 weeks PMA and continuing until the child reaches 18 months corrected age ]

Central Contacts and Locations

Central contacts

Locations

The Children's Hospital of Eastern Ontario

Recruiting

Ottawa, Ontario, Canada, K1H 8L1

Contacts

Sherri Katz, Clinical Study Lead

(613) 737-7600skatz@cheo.on.ca

Mount Sinai Hospital

Recruiting

Toronto, Ontario, Canada, M5G 1X5

Contacts

Montreal Children's Hospital

Recruiting

Montréal, Quebec, Canada, H4A 3J1

Contacts

Gabriel Altit, Co-Site Lead

gabriel.altit@mcgill.ca

Larry Lands, Co-Site Lead

larry.lands@mcgill.ca

More Information

Sponsor

Children's Hospital of Eastern Ontario

Last update posted

Feb 24, 2025

Last verified

Feb, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Children's Hospital of Eastern Ontario on 2025-02-24.