NCT03475264

MRI of Lung Structure and Function in Preterm Children

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 12 (actual)
• Sponsor: The Hospital for Sick Children · Academic / Other
• Sex: All
• Age: 6 Years – 9 Years
• Healthy volunteers: Accepted

Summary

The MRI tools developed by the investigators are well positioned for assessing regional changes in lung structure and function in preterm children with bronchopulmonary dysplasia (BPD), in which airway limitation similar to asthma, alveolar simplification similar to emphysema and pulmonary vascular stunting are expected. To the investigator's knowledge, the combination of ultra short echo time (UTE) proton, pulmonary vascular proton and hyperpolarized 129Xe MRI have not yet been explored in BPD, either clinically or preclinically. The investigators propose that a comprehensive MRI examination may be useful from a diagnostic perspective, MRI of preterm children without BPD may reveal changes which are otherwise clinically 'silent' yet still place children at risk for future chronic lung disease in later life.

Detailed description

Briefly, at the beginning of an approximate three hour study visit, the qualified investigator (QI) / delegate will explain the study procedure to the participants and the participants will have an opportunity to ask questions regarding the study procedure. Following the explanation of the study, written informed consent will be collected at the beginning of visit 1. Participants who are deemed unable to provide consent will be provided an assent form and consent will be acquired from their parents/ legal guardians. During the study visit, participants will undergo: 1) brief medical history and clinical examination including questionnaires, 2) full pulmonary function tests, lung clearance testing (LCI), forced oscillation technique (FoT) and exercise testing, 3) proton MRI, 4) spin-density and/or diffusion-weighted 129Xe MRI, 5) Multiple-breath washout imaging. Qualified research team members will perform a clinical examination on the participant to record their vital statistics like age, gender, height, weight, heart rate, respiratory rate, oral temperature and blood pressure. The QI/delegate, during a brief conversation with the participant, will collect relevant medical history from the participant to make sure the participant meets all the inclusion/exclusion criteria for the study. The QI will also make sure that the participant understands the study procedure and is willing to participate in the study. Based on the clinical examination results, medical history and the pulmonary function test results, the QI/delegate will determine if all the inclusion/exclusion criteria are met to proceed with the MRI part of the study visit.

Conditions

• Bronchopulmonary Dysplasia

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Lung MRI	Participants will be undergoing hyperpolarized xenon and proton lung MRI

Timeline

• Start date: 2018-09-01
• Primary completion: 2019-10-08
• Completion: 2019-10-08
• First posted: 2018-03-23
• Last updated: 2025-08-01

Locations

1 site across 1 country: Canada