MRI in BPD Subjects

NCT03657693 | Recruiting DMC FDA Device

• 1 other identifier: CIN_BPD_COE_001
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

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)

Conditions

Bronchopulmonary Dysplasia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Polysomnography

  within a week of baseline MRI

Other Outcomes (1)

• Change in the anatomic phenotype using MRI

  1 month post baseline and discharge from NICU

Study Arms (2)

BPD

Infants born premature requiring oxygen

Diagnostic Test: NICU MRI; Diagnostic Test: Polysomnography

Controls

Diagnostic Test: NICU MRI; Diagnostic Test: Polysomnography

Interventions

NICU MRI DIAGNOSTIC_TEST

MRI device that is not FDA approved.

BPD; Controls

Polysomnography DIAGNOSTIC_TEST

Polysomnography to better determine obstruction index in the airway.

BPD; Controls

Eligibility Criteria

• Age: Up to 4 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Bronchopulmonary Dysplasia (BPD)

You may qualify if:

• any term age NICU patient

You may not qualify if:

• \- 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).

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead

Study Sites (1)

Megan Schmitt

Cincinnati, Ohio, 45229, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine and remnant blood and BAL samples

MeSH Terms

Conditions

Bronchopulmonary Dysplasia

Interventions

Polysomnography

Condition Hierarchy (Ancestors)

Ventilator-Induced Lung Injury; Lung Injury; Lung Diseases; Respiratory Tract Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Monitoring, Physiologic; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Jason Woods, PhD

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Megan Schmitt

CONTACT

(513) 636-9348; Megan.Schmitt@cchmc.org

Ashley Bordon, MS

CONTACT

5136360143; Ashley.Bordon@cchmc.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2018
• First Posted: September 5, 2018
• Study Start: May 4, 2018
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2030
• Last Updated: January 7, 2026

Record last verified: 2026-01

Locations

US (1)