MRI of Lung Structure and Function in Preterm Children

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Brief Title

MRI of Lung Structure and Function in Preterm Children

Official Title

MRI of Lung Structure and Function in Preterm Children

Brief 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.
    


Study Type

Observational


Primary Outcome

MRI ventilation and 1H MRI thoracic cavity volume and tissue density

Secondary Outcome

 Apparent Diffusion Coefficients (ADC) and ADC maps

Condition

Bronchopulmonary Dysplasia

Intervention

Lung MRI

Study Arms / Comparison Groups

 Healthy
Description:  Healthy Participants

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Diagnostic Test

Estimated Enrollment

21

Start Date

September 1, 2018

Completion Date

December 2020

Primary Completion Date

December 2020

Eligibility Criteria

        Inclusion Criteria:

        - Children born pre-term at less than 28 weeks' gestation, currently aged 6-9 years, with
        and without BPD will be included.

        For the preterm non-BPD cohort, inclusion will include

          -  no requirement of supplementary oxygen beyond 28 days from birth. For the BPD preterm
             cohort, inclusion criteria will include

          -  need for oxygen at 36 weeks' postmenstrual age, which includes those with
             moderate-severe disease .

        For the healthy cohort, inclusion will include

        -absence of any diagnosed pulmonary disease and term birth.

        Exclusion Criteria: Children with

          -  known interstitial lung disease, congenital lung anomalies, cystic fibrosis, ciliary
             dysfunction, immunodeficiency, neuromuscular disease or structural heart disease,
             which may have associated pulmonary function tests (PFT) and/or MRI findings;

          -  genetic syndromes which may have other associated structural lung anomalies;

          -  any contraindications for MRI

          -  severe neurosensory deficits which would prevent test completion;

          -  viral or bacterial respiratory infection within 6 weeks will be excluded. For all
             three groups (healthy, preterm non-BPD and preterm BPD), we will exclude

          -  those with congenital lung disease (i.e. Congenital diaphragmatic hernia (CDH), lung
             cysts) or non BPD acquired chronic lung disease as defined by need for any routine
             supplementary oxygen

          -  if the participant has an MRI incompatible device or any metal in their body which
             cannot be removed, including but not limited to pacemakers, neurostimulators,
             biostimulators, implanted insulin pumps, aneurysm clips, bio prosthetic, artificial
             limb, metallic fragment or foreign body, shunt, surgical staples (including clips or
             metallic sutures and/or ear implants).
      

Gender

All

Ages

6 Years - 9 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

, 4168137654, [email protected]

Location Countries

Canada

Location Countries

Canada

Administrative Informations


NCT ID

NCT03475264

Organization ID

1000055897


Responsible Party

Principal Investigator

Study Sponsor

The Hospital for Sick Children


Study Sponsor

, , 


Verification Date

January 2020