MRI in BPD Subjects
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: NICU MRI, Polysomnography.
- Who it may be relevant to
- Registry conditions: Bronchopulmonary Dysplasia. Basic parameters: up to 4 months · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
MRI for Quantitative Measurement of Pulmonary Growth and Development in Term and Extremely Pre-Term Babies in the BPD Center of Excellence
Overview
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.
Interventions
- Diagnostic test NICU MRI
MRI device that is not FDA approved. - Diagnostic test Polysomnography
Polysomnography to better determine obstruction index in the airway.
Primary outcome measures
- Anatomic phenotypes using MRI [Time frame: baseline]
Secondary outcome measures (1)
- Polysomnography [Time frame: within a week of baseline MRI]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Megan Schmitt — Cincinnati
Identifiers
NCT: NCT03657693 · CIN_BPD_COE_001