MRI in BPD Subjects

Bronchopulmonary Dysplasia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03657693
• Other study ID #: CIN_BPD_COE_001
• Status: Recruiting
• Start date: May 4, 2018
• Est. completion date: August 2025

Study information

• Verified date: October 2023
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: Megan Schmitt
• Phone: (513) 636-9348
• Email: Megan.Schmitt[@]cchmc.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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)

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: August 2025
• Est. primary completion date: August 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 4 Months

Eligibility

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.

Related Conditions & MeSH terms

• Bronchopulmonary Dysplasia

Intervention

Diagnostic Test:
• NICU MRI
MRI device that is not FDA approved.
• Polysomnography
Polysomnography to better determine obstruction index in the airway.

Locations

Country	Name	City	State
United States	Megan Schmitt	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	Polysomnography	Determine the correlation between upper airway MRI and the obstruction index in the polysomnography.	within a week of baseline MRI