MRI in BPD Subjects
Status: | Recruiting |
---|---|
Conditions: | Bronchitis |
Therapuetic Areas: | Pulmonary / Respiratory Diseases |
Healthy: | No |
Age Range: | Any |
Updated: | 9/7/2018 |
Start Date: | May 4, 2018 |
End Date: | December 1, 2021 |
Contact: | Erin Watters, BA |
Email: | erin.watters@cchmc.org |
Phone: | 513-803-7024 |
MRI for Quantitative Measurement of Pulmonary Growth and Development in Term and Extremely Pre-Term Babies in the BPD Center of Excellence
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)
them better understand prematurity and the development of a breathing disorder call BPD
(Bronchopulmonary Dysplasia)
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.
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.
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.
We found this trial at
1
site
3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
Cincinnati, Ohio 45229
1-513-636-4200
Principal Investigator: Jason Woods, Ph.D.
Phone: 513-803-7024
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
Click here to add this to my saved trials