Ignite Creation Date:
2025-12-24 @ 10:35 PM
Ignite Modification Date:
2025-12-31 @ 3:00 PM
Study NCT ID:
NCT07057635
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-07-10
First Post:
2025-06-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Wireless Irradiance SEnsors During Neonatal Phototherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051556', 'term': 'Hyperbilirubinemia, Neonatal'}, {'id': 'D007567', 'term': 'Jaundice, 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': 'ESTIMATED', 'count': 6}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-07-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-09-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-30', 'studyFirstSubmitDate': '2025-06-30', 'studyFirstSubmitQcDate': '2025-06-30', 'lastUpdatePostDateStruct': {'date': '2025-07-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Light Intensity', 'timeFrame': '3 Hours', 'description': 'Comparison of intensity (µW/cm\\^2) data between the Wearifi Bili Light Dosimeter and gold-standard Ohmeda BiliBlanket Light meter at 3 time points: start, 1.5 h and end.'}], 'secondaryOutcomes': [{'measure': 'Cumulative Dose', 'timeFrame': '3 Hours', 'description': 'To determine the cumulative phototherapy dose (µ J/cm\\^2) measured with the Wearifi Bili Light Dosimeter during the study period.'}, {'measure': 'Data Transmission & Gaps', 'timeFrame': '2 Months', 'description': 'Evaluation of data transmission and possible gaps from the Wearifi Bili Light Dosimeter.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Neonatal Hyperbilirubinemia', 'Jaundice, Neonatal', 'Phototherapy Complication', 'Newborn Complication']}, 'descriptionModule': {'briefSummary': 'Bilisensors are devices designed to measure the cumulative dose of phototherapy administered to neonates undergoing treatment for hyperbilirubinemia. The current standard of care typically involves intermittent spot measurements once a day using a handheld dosimeter that may give variable estimations. In contrast, bilisensors may enable continuous, real-time monitoring of light exposure, helping to know the total phototherapy dose received by the infant.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Any micro premature, preterm or term neonate admitted to NICU undergoing phototherapy due to indirect hyperbilirubinemia will be considered for this pilot study. A convenience sample size of 6 patients will be enrolled.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Participants must be admitted to the Montreal Children's Hospital (MCH) Neonatal Intensive Care Unit (NICU)\n* Under phototherapy as clinically indicated\n* Diagnosis of indirect hyperbilirubinemia\n* Weight of \\>1000g at time of enrollment\n\nExclusion Criteria:\n\n* Any abnormal skin conditions (example: extreme dryness, desquamation, congenital skin disorders, etc.)\n* Diagnosis of direct hyperbilirubinemia\n* Weight of \\<1000g at time of enrollment\n* Any baby or family deemed ineligible (ex. too much stress, too unstable) by the clinical care team"}, 'identificationModule': {'nctId': 'NCT07057635', 'acronym': 'WISE', 'briefTitle': 'Wireless Irradiance SEnsors During Neonatal Phototherapy', 'organization': {'class': 'OTHER', 'fullName': 'McGill University Health Centre/Research Institute of the McGill University Health Centre'}, 'officialTitle': 'Wireless Irradiance SEnsors During Neonatal Phototherapy: The WISE Clinical Study', 'orgStudyIdInfo': {'id': 'WISE Clinical'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Extremely Preterm Infant', 'description': 'Weighing \\< 1500g at recruitment.'}, {'label': 'Late Preterm Infant', 'description': 'Weighing between between 1500g and 2500g at recruitment.'}, {'label': 'Term Infant', 'description': 'Weighing \\> 2500g at recruitment.'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Alyssa Maximov, BSc', 'role': 'CONTACT', 'email': 'alyssa.maximov@muhc.mcgill.ca', 'phone': '5149341934', 'phoneExt': '78229'}], 'overallOfficials': [{'name': "Guilherme Sant'Anna, MD, PhD", 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'RI-MUHC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'McGill University Health Centre/Research Institute of the McGill University Health Centre', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Neonatologist', 'investigatorFullName': "Guilherme Sant'Anna, MD", 'investigatorAffiliation': 'McGill University Health Centre/Research Institute of the McGill University Health Centre'}}}}