Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Bronchopulmonary Dysplasia
Type
Observational
Design
Observational Model: Case-ControlTime Perspective: Prospective

Participation Requirements

Age
Between 6 years and 9 years
Gender
Both males and females

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, wr...

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.

Tracking Information

NCT #
NCT03475264
Collaborators
Not Provided
Investigators
Not Provided