Ignite Creation Date:
2025-12-25 @ 1:18 AM
Ignite Modification Date:
2026-01-31 @ 12:38 PM
Study NCT ID:
NCT03657693
Status:
RECRUITING
Last Update Posted:
2025-09-05
First Post:
2018-05-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MRI in BPD Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001997', 'term': 'Bronchopulmonary Dysplasia'}], 'ancestors': [{'id': 'D055397', 'term': 'Ventilator-Induced Lung Injury'}, {'id': 'D055370', 'term': 'Lung Injury'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D007235', 'term': 'Infant, Premature, Diseases'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017286', 'term': 'Polysomnography'}], 'ancestors': [{'id': 'D008991', 'term': 'Monitoring, Physiologic'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Urine and remnant blood and BAL samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 160}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-05-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2029-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-03', 'studyFirstSubmitDate': '2018-05-16', 'studyFirstSubmitQcDate': '2018-08-31', 'lastUpdatePostDateStruct': {'date': '2025-09-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2018-09-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in the anatomic phenotype using MRI', 'timeFrame': '1 month post baseline and discharge from NICU', 'description': "Compare the parenchymal reader scoring, cardiac analysis, and airway scoring over the span of the BPD infant's time in the NICU."}], 'primaryOutcomes': [{'measure': 'Anatomic phenotypes using MRI', 'timeFrame': 'baseline', 'description': 'Investigate parenchymal and vascular structures, regional cardiopulmonary function, and dynamic airway collapse in BPD infants during quiet unsedated breathing.'}], 'secondaryOutcomes': [{'measure': 'Polysomnography', 'timeFrame': 'within a week of baseline MRI', 'description': 'Determine the correlation between upper airway MRI and the obstruction index in the polysomnography.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Bronchopulmonary Dysplasia']}, 'descriptionModule': {'briefSummary': '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)', 'detailedDescription': "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.\n\nSub-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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '4 Months', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Bronchopulmonary Dysplasia (BPD)', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* any term age NICU patient\n\nExclusion Criteria:\n\n* \\- ECMO,\n* Evidence of congenital diseases that may affect lung development, such as congenital diaphragmatic hernia,\n* Suspected muscular dystrophy or neurologic disorder that may affect lung development.\n* Significant genetic or chromosomal abnormalities that may affect lung development\n* Evidence of any respiratory infection at the time of imaging (imaging may be rescheduled for a common viral infection such as a cold).\n* 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.'}, 'identificationModule': {'nctId': 'NCT03657693', 'briefTitle': 'MRI in BPD Subjects', 'organization': {'class': 'OTHER', 'fullName': "Children's Hospital Medical Center, Cincinnati"}, 'officialTitle': 'MRI for Quantitative Measurement of Pulmonary Growth and Development in Term and Extremely Pre-Term Babies in the BPD Center of Excellence', 'orgStudyIdInfo': {'id': 'CIN_BPD_COE_001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'BPD', 'description': 'Infants born premature requiring oxygen', 'interventionNames': ['Diagnostic Test: NICU MRI', 'Diagnostic Test: Polysomnography']}, {'label': 'Controls', 'interventionNames': ['Diagnostic Test: NICU MRI', 'Diagnostic Test: Polysomnography']}], 'interventions': [{'name': 'NICU MRI', 'type': 'DIAGNOSTIC_TEST', 'description': 'MRI device that is not FDA approved.', 'armGroupLabels': ['BPD', 'Controls']}, {'name': 'Polysomnography', 'type': 'DIAGNOSTIC_TEST', 'description': 'Polysomnography to better determine obstruction index in the airway.', 'armGroupLabels': ['BPD', 'Controls']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45229', 'city': 'Cincinnati', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Megan Schmitt', 'role': 'CONTACT', 'email': 'Megan.Schmitt@cchmc.org', 'phone': '513-636-9348'}, {'name': 'Ashley Bordon', 'role': 'CONTACT', 'email': 'Ashley.Bordon@cchmc.org', 'phone': '5136360143'}, {'name': 'Jason Woods, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Megan Schmitt', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}], 'centralContacts': [{'name': 'Megan Schmitt', 'role': 'CONTACT', 'email': 'Megan.Schmitt@cchmc.org', 'phone': '(513) 636-9348'}, {'name': 'Ashley Bordon, MS', 'role': 'CONTACT', 'email': 'Ashley.Bordon@cchmc.org', 'phone': '5136360143'}], 'overallOfficials': [{'name': 'Jason Woods, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Hospital Medical Center, Cincinnati"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Hospital Medical Center, Cincinnati", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}