Ignite Creation Date:
2025-12-25 @ 3:37 AM
Ignite Modification Date:
2026-02-23 @ 12:22 PM
Study NCT ID:
NCT03723005
Status:
COMPLETED
Last Update Posted:
2023-04-10
First Post:
2018-10-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Light Emitting Diode (LED) Mattress for Phototherapy of Jaundiced Newborns
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051556', 'term': 'Hyperbilirubinemia, Neonatal'}], 'ancestors': [{'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D006932', 'term': 'Hyperbilirubinemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 41}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2023-04-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-06', 'studyFirstSubmitDate': '2018-10-24', 'studyFirstSubmitQcDate': '2018-10-25', 'lastUpdatePostDateStruct': {'date': '2023-04-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total Bilirubin (TB) Levels', 'timeFrame': 'up to 1 week', 'description': 'Efficacy of each device (neoLight and conventional devices) will be assessed as a decrease in TB levels (in mg/dL/hr) for each infant in each study group'}, {'measure': 'Duration of Phototherapy', 'timeFrame': 'up to 1 week', 'description': 'Efficacy of each device (neoLight and conventional devices) will also be assessed as the duration (in hrs) of phototherapy for each infant in each study group.'}], 'secondaryOutcomes': [{'measure': 'Irradiance Stability of the neoLight Device', 'timeFrame': '1 year', 'description': 'The performance of the neoLight will be assessed as the stability of irradiance emitted by the neoLight device during the use of the device'}, {'measure': 'Infant Temperature Change', 'timeFrame': 'up to 1 week', 'description': "Safety of the neoLight device will be assessed as no change in an infant's temperature during phototherapy"}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Hyperbilirubinemia, Neonatal']}, 'descriptionModule': {'briefSummary': 'The new investigational and FDA-approved device is named "SkyLife" and is a mattress, which uses blue LEDs as the light source similar to those used in the currently-used overhead blue LED panel devices.', 'detailedDescription': 'The new investigational and FDA-approved device is named "SkyLife" and is a mattress, which uses blue LEDs as the light source similar to those used in the currently-used overhead blue LED panel devices. It is believed that this device will not only avoid many of the side effects when fluorescent tube lights are used, since it delivers safer, non-ultraviolet light; but may also be more effective than currently-used blankets or mattresses, which use blue halogen lamps or fluorescent tubes as light sources. The light is emitted under the baby. This study will discover if this device should be used in place of the currently-used devices.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '8 Months', 'minimumAge': '28 Weeks', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All infants (not gender or racial/ethnically based) equal or greater than 28 weeks GA and great than 6 hrs of age until hospital discharge.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female newborns greater of equal to 28 weeks GA\n* Parental informed consent\n* Enrollment at age greater than 6 hrs of age until neonatal discharge\n* Phototherapy routine order\n\nExclusion Criteria:\n\n* Infant requiring respiratory assistance (such as mechanical ventilation)\n* Severe or life-threatening congenital anomalies\n* Blood transfusion history'}, 'identificationModule': {'nctId': 'NCT03723005', 'briefTitle': 'A Light Emitting Diode (LED) Mattress for Phototherapy of Jaundiced Newborns', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'A Light Emitting Diode (LED) Mattress for Phototherapy of Jaundiced Newborns', 'orgStudyIdInfo': {'id': 'IRB-41341'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Neolight Phototherapy Mattress', 'description': 'Once a qualified patient is enrolled, he/she will be randomized to Neolight phototherapy or standard-of-care phototherapy, which is ordered by physician as part of routine. Duration of phototherapy exposure will be recorded as entered by RN in patient medical progress notes.', 'interventionNames': ['Device: Neolight Phototherapy Mattress']}, {'label': 'Standard-of-Care Phototherapy', 'description': 'Once a qualified patient is enrolled, he/she will be randomized to Neolight phototherapy or standard-of-care phototherapy, which is ordered by physician as part of routine. Duration of phototherapy exposure will be recorded as entered by RN in patient medical progress notes.', 'interventionNames': ['Device: Standard-of-Care']}], 'interventions': [{'name': 'Neolight Phototherapy Mattress', 'type': 'DEVICE', 'description': 'Once a qualified patient is enrolled, he/she will be randomized to Neolight phototherapy or standard-of-care phototherapy, which is ordered by physician as part of routine. Duration of phototherapy exposure will be recorded as entered by RN in patient medical progress notes.', 'armGroupLabels': ['Neolight Phototherapy Mattress']}, {'name': 'Standard-of-Care', 'type': 'DEVICE', 'description': 'Once a qualified patient is enrolled, he/she will be randomized to Neolight phototherapy or standard-of-care phototherapy, which is ordered by physician as part of routine. Duration of phototherapy exposure will be recorded as entered by RN in patient medical progress notes.', 'armGroupLabels': ['Standard-of-Care Phototherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94305', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}], 'overallOfficials': [{'name': 'Ronald J Wong, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Investigator'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Sharable statistical data in regards to efficacy of device compared to Standard-of-care devices already used in a hospital setting.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'collaborators': [{'name': 'NeoLight, LLC.', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PI', 'investigatorFullName': 'David K Stevenson', 'investigatorAffiliation': 'Stanford University'}}}}