MRI in BPD Subjects

NCT ID: NCT03657693

Last Updated: 2026-01-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

160 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-05-04

Study Completion Date

2030-12-31

Brief Summary

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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

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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.

Conditions

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Bronchopulmonary Dysplasia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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BPD

Infants born premature requiring oxygen

NICU MRI

Intervention Type DIAGNOSTIC_TEST

MRI device that is not FDA approved.

Polysomnography

Intervention Type DIAGNOSTIC_TEST

Polysomnography to better determine obstruction index in the airway.

Controls

NICU MRI

Intervention Type DIAGNOSTIC_TEST

MRI device that is not FDA approved.

Polysomnography

Intervention Type DIAGNOSTIC_TEST

Polysomnography to better determine obstruction index in the airway.

Interventions

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NICU MRI

MRI device that is not FDA approved.

Intervention Type DIAGNOSTIC_TEST

Polysomnography

Polysomnography to better determine obstruction index in the airway.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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).
Maximum Eligible Age

4 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Children's Hospital Medical Center, Cincinnati

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jason Woods, PhD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Medical Center, Cincinnati

Locations

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Megan Schmitt

Cincinnati, Ohio, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Megan Schmitt

Role: CONTACT

(513) 636-9348

Ashley Bordon, MS

Role: CONTACT

5136360143

Facility Contacts

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Megan Schmitt

Role: primary

5136369348

Ashley Bordon

Role: backup

5136360143

Other Identifiers

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CIN_BPD_COE_001

Identifier Type: -

Identifier Source: org_study_id

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