MRI of Lung Structure and Function in Preterm Children

NCT03475264 | Terminated

• 1 other identifier: 1000055897
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Bronchopulmonary Dysplasia

Keywords

Lung MRI, Bronchopulmonary Dysplasia, hyperpolarized xenon,

Outcome Measures

Primary Outcomes (1)

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

  Ventilation defect percent (VDP) (%) will be generated for whole lung and individual lung slices using manual or semi-automated segmentation. For proton (1H) thoracic cavity images, the thoracic cavity volume (TCV) will be calculated by manual or semi-automated segmentation.

  2 years

Secondary Outcomes (2)

• Apparent Diffusion Coefficients (ADC) and ADC maps

  2 years

• Multiple breath washout testing:

  2 years

Study Arms (3)

Healthy

Healthy Participants

Diagnostic Test: Lung MRI

BPD cohort

Participants born prematurely with a diagnosis of BPD

Diagnostic Test: Lung MRI

Non-BPD cohort

Participants born prematurely without a diagnosis of BPD

Diagnostic Test: Lung MRI

Interventions

Lung MRI DIAGNOSTIC_TEST

Participants will be undergoing hyperpolarized xenon and proton lung MRI

BPD cohort; Healthy; Non-BPD cohort

Eligibility Criteria

• Age: 6 Years - 9 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Healthy volunteers will be selected from the general population and the BPD and non-BPD cohorts will be selected from patients from clinics seen at the Hospital for Sick Children, Toronto

You may qualify if:

• \- Children born pre-term at less than 28 weeks' gestation, currently aged 6-9 years, with and without BPD will be included.
• need for oxygen at 36 weeks' postmenstrual age, which includes those with moderate-severe disease .
• absence of any diagnosed pulmonary disease and term birth.

You may not qualify if:

• 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).

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

MeSH Terms

Conditions

Bronchopulmonary Dysplasia

Condition Hierarchy (Ancestors)

Ventilator-Induced Lung Injury; Lung Injury; Lung Diseases; Respiratory Tract Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Scientist

Study Record Dates

• First Submitted: February 6, 2018
• First Posted: March 23, 2018
• Study Start: September 1, 2018
• Primary Completion: October 8, 2019
• Study Completion: October 8, 2019
• Last Updated: August 1, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)