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 Information
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
Administrative Informations
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