MRI in BPD Subjects

Brief Title

MRI in BPD Subjects

Official Title

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

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.
    

Study Type

Observational

Primary Outcome

Anatomic phenotypes using MRI

Secondary Outcome

 Polysomnography

Condition

Bronchopulmonary Dysplasia

Intervention

NICU MRI

Study Arms / Comparison Groups

 BPD

Description:  Infants born premature requiring oxygen

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Diagnostic Test

Estimated Enrollment

160

Start Date

May 4, 2018

Completion Date

December 1, 2021

Primary Completion Date

June 1, 2021

Eligibility Criteria

        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.
      

Gender

All

Ages

N/A - 4 Months

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Jason Woods, PhD, (513)803-4781, [email protected]

Location Countries

United States

Location Countries

United States

NCT ID

NCT03657693

Organization ID

CIN_BPD_COE_001

Responsible Party

Sponsor

Study Sponsor

Children's Hospital Medical Center, Cincinnati

Study Sponsor

Jason Woods, PhD, Principal Investigator, Children's Hospital Medical Center, Cincinnati

Verification Date

January 2020