MRI in BPD Subjects

Recruiting

• Conditions: Bronchopulmonary Dysplasia
• Interventions: Diagnostic Test: NICU MRI; Diagnostic Test: Polysomnography

• Registration Number: NCT03657693
• Lead Sponsor: Children's Hospital Medical Center, Cincinnati

Brief 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)

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 Timeline

• Study Start: 2018-05-04
• Study First Submitted: 2018-05-16
• Study First Submitted QC: 2018-08-31
• Study First Posted: 2018-09-05
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-18
• Last Update Posted: 2024-11-20
• Primary Completion: 2025-08
• Study Completion: 2025-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 160

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Controls	Polysomnography	-
Controls	NICU MRI	-
BPD	NICU MRI	Infants born premature requiring oxygen
BPD	Polysomnography	Infants born premature requiring oxygen

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Polysomnography	within a week of baseline MRI	Determine the correlation between upper airway MRI and the obstruction index in the polysomnography.

Trial Locations

Locations (1)

Megan Schmitt; 🇺🇸 Cincinnati, Ohio, United States