Ignite Creation Date:
2025-12-25 @ 1:44 AM
Ignite Modification Date:
2025-12-26 @ 3:05 AM
Study NCT ID:
NCT07150494
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-30
First Post:
2025-08-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Predictive and Diagnostic Value of BIND Score in Assessment of Severe Neonatal Jaundice Cases in Neonatal Intensive Care Unit
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010789', 'term': 'Phototherapy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-29', 'studyFirstSubmitDate': '2025-08-25', 'studyFirstSubmitQcDate': '2025-08-25', 'lastUpdatePostDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Decrease high billirubin level', 'timeFrame': 'One year duration', 'description': 'We use bind score to evaluate neurological condition of neoborns then use photo therapy to decrease'}, {'measure': 'Predictive and diagnostic value of BIND score in assessment of severe neonatal jaundice cases in NICU', 'timeFrame': 'Baseline', 'description': 'Early detection and prevention of neonatal encephalopathy using BIND score.'}, {'measure': 'Predictive and diagnostic value of BIND score in assessment of severe neonatal jaundice cases in NICU', 'timeFrame': 'Baseline'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Neonatal Hyperbilirubinemia']}, 'referencesModule': {'references': [{'pmid': '40815110', 'type': 'BACKGROUND', 'citation': 'Vongbhavit K, Rearkyai S, Janyoungsak P, Panburana J. Impact of 2022 AAP Neonatal Hyperbilirubinemia Guidelines in a Middle-Income Country: A Single-Center Study in Thailand. Neonatology. 2025;122(6):660-668. doi: 10.1159/000547630. Epub 2025 Aug 13.'}], 'seeAlsoLinks': [{'url': 'https://bmcpediatr.biomedcentral.com/articles/10.1186/s12887-015-0355-2', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'Early detection and prevention of neonatal encephalopathy using BIND score.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '28 Days', 'minimumAge': '1 Day', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Neonates with severe neonatal jaundice', 'eligibilityCriteria': 'Inclusion criteria:\n\nNewborn \\< 28 days old Neonates with severe hyperbilirubinemia need extensive phototherapy impending exchange transfusion\n\nExclusion criteria:\n\nAge \\> 28 days old Neonates with any abnormal neurological signs suggesting neurological disease (hypoxic ischemic encephalopathy, muscle disease, …etc.).'}, 'identificationModule': {'nctId': 'NCT07150494', 'briefTitle': 'Predictive and Diagnostic Value of BIND Score in Assessment of Severe Neonatal Jaundice Cases in Neonatal Intensive Care Unit', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Predictive and Diagnostic Value of BIND Score in Assessment of Severe Neonatal Jaundice Cases in NICU', 'orgStudyIdInfo': {'id': 'Neonatal jaundice cases in nic'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Phototherapy', 'type': 'DEVICE', 'description': 'Phototherapy used to decrease high billirubin level in neonatal jaundice'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Nouralhoda Ahmed Metwally', 'role': 'CONTACT', 'email': 'nouralhoda2712@gmail.com', 'phone': '+201012527376'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Nouralhoda Ahmed', 'investigatorFullName': 'Nouralhoda Ahmed Metwally Ibrahim', 'investigatorAffiliation': 'Assiut University'}}}}