Ignite Creation Date:
2025-12-26 @ 10:36 AM
Ignite Modification Date:
2026-03-24 @ 7:11 AM
Study NCT ID:
NCT02570828
Status:
COMPLETED
Last Update Posted:
2017-01-16
First Post:
2015-10-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Thermal Imaging in Neonates: A Feasibility Study in Healthy Babies and Babies With Suspected TTN
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059246', 'term': 'Tachypnea'}, {'id': 'D011014', 'term': 'Pneumonia'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-12', 'studyFirstSubmitDate': '2015-10-06', 'studyFirstSubmitQcDate': '2015-10-06', 'lastUpdatePostDateStruct': {'date': '2017-01-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-10-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'asymmetric heat distribution', 'timeFrame': 'within the first 3 days of life', 'description': 'thermal imaging will be used to capture asymmetric heat distribution across lung fields'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['healthy neonate, tachypnea, thermal imaging, pneumonia'], 'conditions': ['Thermal Imaging, Neonatal Pneumonia, Tachypnea']}, 'descriptionModule': {'briefSummary': "This is a study to evaluate thermal imaging as a technology to monitor the normal clearing of amniotic fluid from healthy newborns and newborns suspected of having a condition called transient tachypnea of the newborn, or TTN. Thermal images are taken using an imaging device that attaches to an iPhone. This device, commercially known as FLIR ONE, creates a non-identifiable image based on the heat pattern of an object. In this case, the object is a child's chest and back. It does not emit any radiation like an x-ray does."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '3 Days', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria (healthy and suspected TTN babies):\n\n* Full term (greater than or equal to 37 weeks gestation)\n* less than 3 days old\n* born via normal vaginal delivery\n\nInclusion Criteria (only for suspected TTN babies):\n\n* neonatologist assesses baby as possibly having TTN\n* chest x-ray done as part of evaluation for TTN\n* no other significant co-morbid conditions present\n\nExclusion Criteria:\n\n* parents do not consent to have baby participate'}, 'identificationModule': {'nctId': 'NCT02570828', 'briefTitle': 'Thermal Imaging in Neonates: A Feasibility Study in Healthy Babies and Babies With Suspected TTN', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'Thermal Imaging in Neonates: a Feasibility Study in Healthy Babies and Babies With Suspected Transient Tachypnea of the Newborn (TTN)', 'orgStudyIdInfo': {'id': '2015P001500'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Thermal imaging', 'description': 'All subjects in the study will have thermal images of the chest taken using the FLIR ONE attachment to an iPhone.', 'interventionNames': ['Device: Thermal Imaging']}], 'interventions': [{'name': 'Thermal Imaging', 'type': 'DEVICE', 'description': 'FLIR ONE attachment to an iPhone', 'armGroupLabels': ['Thermal imaging']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Patricia L Hibberd, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief, Division of Global Health, Department of Pediatrics', 'investigatorFullName': 'Patricia L. Hibberd', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}