Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
160 participants
OBSERVATIONAL
2018-05-04
2030-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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BPD
Infants born premature requiring oxygen
NICU MRI
MRI device that is not FDA approved.
Polysomnography
Polysomnography to better determine obstruction index in the airway.
Controls
NICU MRI
MRI device that is not FDA approved.
Polysomnography
Polysomnography to better determine obstruction index in the airway.
Interventions
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NICU MRI
MRI device that is not FDA approved.
Polysomnography
Polysomnography to better determine obstruction index in the airway.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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).
4 Months
ALL
Yes
Sponsors
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Children's Hospital Medical Center, Cincinnati
OTHER
Responsible Party
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Principal Investigators
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Jason Woods, PhD
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital Medical Center, Cincinnati
Locations
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Megan Schmitt
Cincinnati, Ohio, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CIN_BPD_COE_001
Identifier Type: -
Identifier Source: org_study_id
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