Clinical trial NCT03657693: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Bronchopulmonary Dysplasia
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
First posted: 2018-09-05
Enrollment: 160
Sex: ALL
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Bronchopulmonary Dysplasia (BPD)

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.

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.

Primary outcomes:
measure: Anatomic phenotypes using MRI
timeFrame: baseline
Secondary outcomes:
measure: Polysomnography
timeFrame: within a week of baseline MRI
Other outcomes:
measure: Change in the anatomic phenotype using MRI
timeFrame: 1 month post baseline and discharge from NICU
Locations:
city: Cincinnati
country: United States
facility: Megan Schmitt
state: Ohio
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Jason Woods, PhD
role: PRINCIPAL_INVESTIGATOR
References: