Recruiting

Observational Study

Sponsor:

Children's Hospital Medical Center, Cincinnati

Code:

NCT03657693

Conditions

Bronchopulmonary Dysplasia

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Accepted

Interventions

NICU MRI

Polysomnography

Study Details

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

Study ID

NCT03657693

Start date

May 4, 2018

Status verified date

Jan, 2026

Completion date

Dec 31, 2030

Anticipated

Primary completion date

Dec 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Accepted

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

Enrollment

160 participants

Anticipated

Interventions and Outcome Measures

Arms

BPD

Infants born premature requiring oxygen

Controls

Interventions

NICU MRI

MRI device that is not FDA approved.

Polysomnography

Polysomnography to better determine obstruction index in the airway.

Primary outcome measure

  • Anatomic phenotypes using MRI [ Time Frame: baseline ]

Central Contacts and Locations

Central contacts

Megan Schmitt

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

Ashley Bordon, MS

5136360143Ashley.Bordon@cchmc.org

Locations

Megan Schmitt

Recruiting

Cincinnati, Ohio, United States, 45229

Contacts

Megan Schmitt

5136369348Megan.Schmitt@cchmc.org

Ashley Bordon

5136360143Ashley.Bordon@cchmc.org

Principal Investigator:

Jason Woods, Ph.D.

More Information

Sponsor

Children's Hospital Medical Center, Cincinnati

Last update posted

Jan 7, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Children's Hospital Medical Center, Cincinnati on 2026-01-07.