MRI in BPD Subjects
ConditionBronchopulmonary Dysplasia
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 4
SponsorChildren's Hospital Medical Center, Cincinnati
About this trial
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)
Eligibility criteria
This trial accepts healthy volunteersQualifiers
any term age NICU patient
Disqualifiers
- 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
Trial population
Bronchopulmonary Dysplasia (BPD)
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
NICU MRI
Diagnostic testMRI device that is not FDA approved.
Polysomnography
Diagnostic testPolysomnography to better determine obstruction index in the airway.
Treatment groups
160 Participants
are divided into 2 treatment groupsGroup A: BPD2 interventions
Group B: Controls2 interventions
Trial outcomes
Primary outcomes
1
Anatomic phenotypes using MRI
Investigate parenchymal and vascular structures, regional cardiopulmonary function, and dynamic airway collapse in BPD infants during quiet unsedated breathing.
Time frame
baselineSecondary outcomes
1
Polysomnography
Determine the correlation between upper airway MRI and the obstruction index in the polysomnography.
Time frame
within a week of baseline MRIOther outcomes
1
Change in the anatomic phenotype using MRI
Compare the parenchymal reader scoring, cardiac analysis, and airway scoring over the span of the BPD infant's time in the NICU.
Time frame
1 month post baseline and discharge from NICUSponsors and contacts
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Source ClinicalTrials.gov