Megan Schmitt
Cincinnati, Ohio, 45229, United States
Location status: Recruiting
Location contact
Ashley Bordon
CONTACT
Jason Woods, Ph.D.
PRINCIPAL_INVESTIGATOR
Megan Schmitt
CONTACT
NCT Number: NCT03657693
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)
Interested in participating?
Request InfoUp to 4 month
All sexes
Observational
Cincinnati, Ohio, 45229, United States
Location status: Recruiting
Ashley Bordon
CONTACT
Jason Woods, Ph.D.
PRINCIPAL_INVESTIGATOR
Megan Schmitt
CONTACT
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
MRI device that is not FDA approved.
Polysomnography to better determine obstruction index in the airway.
Time frame: baseline
Investigate parenchymal and vascular structures, regional cardiopulmonary function, and dynamic airway collapse in BPD infants during quiet unsedated breathing.
Time frame: within a week of baseline MRI
Determine the correlation between upper airway MRI and the obstruction index in the polysomnography.
Time frame: 1 month post baseline and discharge from NICU
Compare the parenchymal reader scoring, cardiac analysis, and airway scoring over the span of the BPD infant's time in the NICU.
Contact information is provided by the study sponsor or research team.
Ashley Bordon, MS
CONTACT
Megan Schmitt
CONTACT
Children's Hospital Medical Center, Cincinnati
Other
MRI for Quantitative Measurement of Pulmonary Growth and Development in Term and Extremely Pre-Term Babies in the BPD Center of Excellence
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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