Ignite Creation Date:
2025-12-25 @ 1:18 AM
Ignite Modification Date:
2026-01-31 @ 12:38 PM
Study NCT ID:
NCT03657693
Status:
RECRUITING
Last Update Posted:
2025-09-05
First Post:
2018-05-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MRI in BPD Subjects
Sponsor:
Children's Hospital Medical Center, Cincinnati
Organization:
Study Overview
Official Title:
MRI for Quantitative Measurement of Pulmonary Growth and Development in Term and Extremely Pre-Term Babies in the BPD Center of Excellence
Status:
RECRUITING
Status Verified Date:
2024-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: