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NCT Number: NCT03657693

MRI in BPD Subjects

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)

Recruiting

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Key information

Age range

Up to 4 month

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

NICU MRI

Diagnostic Test

MRI device that is not FDA approved.

Polysomnography

Diagnostic Test

Polysomnography to better determine obstruction index in the airway.

Primary outcomes

  1. Anatomic phenotypes using MRI

    Time frame: baseline

    Investigate parenchymal and vascular structures, regional cardiopulmonary function, and dynamic airway collapse in BPD infants during quiet unsedated breathing.

Secondary outcomes

  1. Polysomnography

    Time frame: within a week of baseline MRI

    Determine the correlation between upper airway MRI and the obstruction index in the polysomnography.

Other outcomes

  1. Change in the anatomic phenotype using MRI

    Time frame: 1 month post baseline and discharge from NICU

    Compare the parenchymal reader scoring, cardiac analysis, and airway scoring over the span of the BPD infant's time in the NICU.

Study contacts

Contact information is provided by the study sponsor or research team.

Ashley Bordon, MS

CONTACT

[email protected]

5136360143

Megan Schmitt

CONTACT

[email protected]

(513) 636-9348

Sponsors and collaborators

Lead sponsor

Children's Hospital Medical Center, Cincinnati

Other

Registry information

Official study title

MRI for Quantitative Measurement of Pulmonary Growth and Development in Term and Extremely Pre-Term Babies in the BPD Center of Excellence

Important dates

Study start
2018
Primary completion
2028
Study completion
2030
First posted
Sep 5, 2018
Registry last updated
Jan 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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