Ignite Creation Date:
2025-12-24 @ 11:13 PM
Ignite Modification Date:
2025-12-25 @ 8:49 PM
Study NCT ID:
NCT05257369
Status:
UNKNOWN
Last Update Posted:
2022-02-25
First Post:
2022-02-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Broad Band Emission LED Phototherapy Source Versus Narrow Band
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'no masking'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Prospective randomized controlled trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 110}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2022-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-02-16', 'studyFirstSubmitDate': '2022-02-08', 'studyFirstSubmitQcDate': '2022-02-16', 'lastUpdatePostDateStruct': {'date': '2022-02-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Adverse outcomes', 'timeFrame': '"Through study completion, an average of 1 month.', 'description': 'Any adverse effects or patologycal symptoms during phototherapy'}], 'primaryOutcomes': [{'measure': 'Bilirubin level reduction', 'timeFrame': '24 hours', 'description': 'Reduction in TSB levels after phototherapy for 24 hours'}], 'secondaryOutcomes': [{'measure': 'Days of phototherapy', 'timeFrame': '"Through study completion, an average of 1 month.', 'description': 'Duration of phototherapy'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Phototherapy', 'Blue light LED', 'Green Light LED'], 'conditions': ['Neonatal Hyperbilirubinemia', 'Jaundice, Neonatal']}, 'descriptionModule': {'briefSummary': "Phototherapy is the most frequently used treatment in neonatology when serum bilirubin levels exceed physiological limits. Light-emitting diodes (LEDs) are become routinely used for phototherapy in neonates with hyperbilirubinemia. Blue LED light with peak emission around 460 nm is regarded as the most suitable light sources for phototherapy and they recommended by most neonatal guidelines. However, the effectiveness of phototherapy with narrow-band LED light sources can be increased by expanding the spectral range of incident radiation within the absorption of bilirubin due to the strongly marked heterogeneity absorption properties of bilirubin in a different microenvironment. Longer wavelength light, such as green light, is expected to penetrate the infant's skin deeper. It is still controversial whether the use of green light has any advantage over blue light. The most effective and safest light source and the optimal method to evaluate phototherapy, however, remain unknown.The aim of this study was to compare, at equal light irradiance, the clinical efficacy of broad spectrum blue- green LED with blue narrow spectral band phototherapy device."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Days', 'minimumAge': '24 Hours', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* non-haemolytic hyperbilirubinaemia, but otherwise healthy, indications for phototherapy based on NICE criteria, gestational age ≥33 weeks, birth weight ≥1800 g, postnatal age \\>24 hrs and ≤14 days\n\nExclusion Criteria:\n\n* hemolytic jaundice, major congenital animalities and history of phototherapy. Infants with indication of intensive treatment double phototherapy were not included.'}, 'identificationModule': {'nctId': 'NCT05257369', 'briefTitle': 'Broad Band Emission LED Phototherapy Source Versus Narrow Band', 'organization': {'class': 'OTHER', 'fullName': 'Erebouni Medical Center'}, 'officialTitle': 'Clinical Efficacy of LED Phototherapy Devices With Blue - Green Versus Blue Light of Equal Irradiance in Neonates With Non Hemolytic Jaundice', 'orgStudyIdInfo': {'id': '003PH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1.Blue-Green LED wide band phototherapy', 'description': 'For experimental group was used "Malysh" phototherapeutic device (Luzar ltd, Belarus); it includes of eighteen blue- green super bright LEDs (12 blue (λmax 476 ) and 6 green (505 nm).', 'interventionNames': ['Device: Blue-Green LED photoherapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2.Blue LED narrow band phototherapy', 'description': 'For control group was used blue LED BILI-THERAPY (Atom Medical Inc., Tokyo, Japan) in high-mode which have a 20 μW/cm2 with peak wavelength between (λmax 480 nm).', 'interventionNames': ['Device: Blue-Green LED photoherapy']}], 'interventions': [{'name': 'Blue-Green LED photoherapy', 'type': 'DEVICE', 'otherNames': ['Blue LED phototherapy'], 'description': 'Continuous phototherapy for 24 h, for newborns placed incubators or radiant warmers will interrupted only for feeding and nursing for 20 - 30 min every three hours.', 'armGroupLabels': ['1.Blue-Green LED wide band phototherapy', '2.Blue LED narrow band phototherapy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Yerevan', 'status': 'RECRUITING', 'country': 'Armenia', 'contacts': [{'name': 'Pavel Mazmanyan, Prof', 'role': 'CONTACT', 'email': 'pavelart@gmail.com', 'phone': '+37410472340'}, {'name': 'Gohar Margaryan, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Erebouni Medical Centre, NICU', 'geoPoint': {'lat': 40.17765, 'lon': 44.5126}}], 'centralContacts': [{'name': 'Pavel Mazmanyan, Prof', 'role': 'CONTACT', 'email': 'pavelart@gmail.com', 'phone': '+37491416589'}, {'name': 'Gohar Margaryan, MD', 'role': 'CONTACT', 'email': 'goharmargaryan1991@mail.ru+', 'phone': '+37496023057'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Erebouni Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Pavel Mazmanyan', 'investigatorFullName': 'Pavel Mazmanyan', 'investigatorAffiliation': 'Erebouni Medical Center'}}}}