MRI in BPD Subjects

MRI for Quantitative Measurement of Pulmonary Growth and Development in Term and Extremely Pre-Term Babies in the BPD Center of Excellence

The investigators are wanting to learn more about early development of the lungs and to help them better understand prematurity and the development of a breathing disorder call BPD (Bronchopulmonary Dysplasia)

Study Overview

• Status: Recruiting
• Conditions: Bronchopulmonary Dysplasia
• Intervention / Treatment: Diagnostic test: NICU MRI; Diagnostic test: Polysomnography

Detailed Description

This is an observational case study involving up to three MRI visits. The first MRI will be complete after the infant's clinical initial evaluation. The second image will be obtained approximately 1 month later and the third MRI will be complete prior to discharge. Infants will be imaged at various ages, based up their initial evaluation. The investigators will collect urine and obtain clinically collected remnant blood around time of MRI, tracheal/endotracheal aspirate at time of the MRI when available and BAL samples as clinically available. MRI findings will be correlated with laboratory findings and outcomes from the medical record, and a research database will be built for the data. The investigators will also obtain a one-time MRI visit in non-BPD NICU patients to acquire data related to normal vasculature and pulmonary alveolar development.

Sub-study 1: Inpatient polysomnography Patients with the same inclusion/exclusion criteria as reported below will be approached for a brief inpatient polysomnogram. The population will include patients with and without BPD. The polysomnography (PSG) will be performed in the NICU within 1 week from the MRI that is obtained prior to discharge.

• Study Type: Observational
• Enrollment (Estimated): 160

Contacts and Locations

• Study Contact: Name: Megan Schmitt; Phone Number: (513) 636-9348; Email: Megan.Schmitt@cchmc.org
• Study Contact Backup: Name: Ashley Bordon, MS; Phone Number: 5136360143; Email: Ashley.Bordon@cchmc.org

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Recruiting
      • Megan Schmitt
      • Principal Investigator: Jason Woods, Ph.D.
      • Contact: Megan Schmitt; Phone Number: 513-636-9348; Email: Megan.Schmitt@cchmc.org
      • Contact: Ashley Bordon; Phone Number: 5136360143; Email: Ashley.Bordon@cchmc.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 4 months (Child)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Bronchopulmonary Dysplasia (BPD)

Description

Inclusion Criteria:

• any term age NICU patient

Exclusion Criteria:

• - ECMO,
• Evidence of congenital diseases that may affect lung development, such as congenital diaphragmatic hernia,
• Suspected muscular dystrophy or neurologic disorder that may affect lung development.
• Significant genetic or chromosomal abnormalities that may affect lung development
• Evidence of any respiratory infection at the time of imaging (imaging may be rescheduled for a common viral infection such as a cold).
• Standard MRI exclusion criteria as set forth by the CCHMC Department of Radiology. This includes any contraindications from tracheostomy tubes that are not MR compatible.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Controls	Diagnostic test: NICU MRI; MRI device that is not FDA approved.; Diagnostic test: Polysomnography; Polysomnography to better determine obstruction index in the airway.
BPD; Infants born premature requiring oxygen	Diagnostic test: NICU MRI; MRI device that is not FDA approved.; Diagnostic test: Polysomnography; Polysomnography to better determine obstruction index in the airway.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anatomic phenotypes using MRI	Investigate parenchymal and vascular structures, regional cardiopulmonary function, and dynamic airway collapse in BPD infants during quiet unsedated breathing.	baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Polysomnography	Determine the correlation between upper airway MRI and the obstruction index in the polysomnography.	within a week of baseline MRI

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the anatomic phenotype using MRI	Compare the parenchymal reader scoring, cardiac analysis, and airway scoring over the span of the BPD infant's time in the NICU.	1 month post baseline and discharge from NICU

Collaborators and Investigators

• Sponsor: Children's Hospital Medical Center, Cincinnati
• Investigators: Principal Investigator: Jason Woods, PhD, Children's Hospital Medical Center, Cincinnati

Study record dates

Study Major Dates

• Study Start (Actual): May 4, 2018
• Primary Completion (Estimated): August 1, 2025
• Study Completion (Estimated): August 1, 2025

Study Registration Dates

• First Submitted: May 16, 2018
• First Submitted That Met QC Criteria: August 31, 2018
• First Posted (Actual): September 5, 2018

Study Record Updates

• Last Update Posted (Actual): October 25, 2023
• Last Update Submitted That Met QC Criteria: October 23, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Infant, Newborn, Diseases; Lung Injury; Infant, Premature, Diseases; Ventilator-Induced Lung Injury; Bronchopulmonary Dysplasia
• Other Study ID Numbers: CIN_BPD_COE_001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes