Clinical trial NCT06065215: Early-life MRI Biomarkers of Longer-term Respiratory Morbidity in Infants Born Extremely Preterm (EMBLEM)
Official title: Early-life MRI Biomarkers of Longer-term Respiratory Morbidity in Infants Born Extremely Preterm (EMBLEM)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lung Function
BPD - Bronchopulmonary Dysplasia
Lead sponsor: Children's Hospital of Eastern Ontario
Sponsor class: OTHER
Collaborators: name: The Hospital for Sick Children
name: MOUNT SINAI HOSPITAL
name: Hannover Medical School
name: St. Justine's Hospital
name: Montreal Children's Hospital of the MUHC
First posted: 2023-10-03
Enrollment: 319
Sex: ALL
Minimum age (years): 35
Maximum age (years): 21
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Babies will be recruited from four Canadian tertiary care pediatric centers: Children's Hospital of Eastern Ontario (CHEO), Ottawa, ON; Mount Sinai Hospital, Toronto, ON; Centre Hospitalier Universitaire Sainte-Justine, Montreal QC; and Montreal Children's Hospital, Montreal QC. MRI will occur at each site except Mount Sinai, whose babies will undergo MRI at The Hospital for Sick Children, Toronto, ON.

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.

Primary outcomes:
measure: Severe Post-prematurity Respiratory Disease (PRD)
timeFrame: 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
Secondary outcomes:
measure: Neurodevelopmental Impairment (NDI)
timeFrame: Neurodevelopmental impairment will be determined at the 18-21 months corrected age visit
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: The Children's Hospital of Eastern Ontario
state: Ontario
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
city: Montréal
country: Canada
facility: CHU-Sainte Justine
state: Quebec
city: Montréal
country: Canada
facility: Montreal Children's Hospital
state: Quebec
Study officials:
affiliation: Children's Hospital of Eastern Ontario
name: Sherri Katz
role: PRINCIPAL_INVESTIGATOR
References: