Ignite Creation Date:
2025-12-25 @ 4:52 AM
Ignite Modification Date:
2025-12-26 @ 3:53 AM
Study NCT ID:
NCT04218318
Status:
RECRUITING
Last Update Posted:
2025-01-03
First Post:
2019-12-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safe Threshold to Discontinue Phototherapy in Hemolytic Disease of Newborn
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004899', 'term': 'Erythroblastosis, Fetal'}, {'id': 'D051556', 'term': 'Hyperbilirubinemia, Neonatal'}, {'id': 'D007565', 'term': 'Jaundice'}, {'id': 'D006932', 'term': 'Hyperbilirubinemia'}, {'id': 'D006461', 'term': 'Hemolysis'}], 'ancestors': [{'id': 'D005315', 'term': 'Fetal Diseases'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012877', 'term': 'Skin Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010789', 'term': 'Phototherapy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A prospective open labeled randomized control trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 84}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2027-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-01', 'studyFirstSubmitDate': '2019-12-18', 'studyFirstSubmitQcDate': '2020-01-02', 'lastUpdatePostDateStruct': {'date': '2025-01-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rebound hyperbilirubinemia', 'timeFrame': '28 days', 'description': "Number of participants of whome concentration of total serum bilirubin returned to or beyond the AAP phototherapy threshold within 72 hours of phototherapy discontinuation of a neonate's first round of phototherapy treatment."}], 'secondaryOutcomes': [{'measure': 'Duration of phototherapy', 'timeFrame': '28 days', 'description': 'Duration of phototherapy'}, {'measure': 'Length of hospital stay', 'timeFrame': '28 days', 'description': 'Length of hospital stay'}, {'measure': 'Adverse effects related to phototherapy', 'timeFrame': '28 days', 'description': 'Number of participants who will develop erythematous rash, loose stool, hyperthermia, and dehydration'}, {'measure': 'Rebound hyperbilirubinemia between 3-7 days after phototherapy stoppage', 'timeFrame': '28 days', 'description': "Number of participants of whome concentration of total serum bilirubin returned to or beyond the AAP phototherapy threshold between 3-7 days of phototherapy discontinuation of a neonate's first round of phototherapy treatment."}, {'measure': 'Rebound TSB level that exceeded the appropriate AAP phototherapy threshold by ≥35 µmol/L after phototherapy stoppage', 'timeFrame': '28 days', 'description': 'Rebound TSB level that exceeded the appropriate AAP phototherapy threshold by ≥35 µmol/L after phototherapy stoppage'}, {'measure': 'Rebound TSB level that exceeded the appropriate AAP exchange transfusion threshold after phototherapy storage', 'timeFrame': '28 days', 'description': 'Number of participants of whome rebound TSB level that exceeded the appropriate AAP exchange transfusion threshold after phototherapy storage'}, {'measure': 'Total Cost of NICU Care', 'timeFrame': '90 days', 'description': 'Total Cost of NICU Care'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Jaundice', 'Newborn', 'Hyperbilirubinemia', 'Rebound hyperbilirubinemia', 'Phototherapy', 'Hemolysis'], 'conditions': ['Hemolytic Disease of Newborn', 'Neonatal Hyperbilirubinemia']}, 'descriptionModule': {'briefSummary': 'We hypothesized that adopting a lower rather than a higher threshold for phototherapy discontinuation will be associated with reduced rates of rebound hyperbilirubinemia in term and late preterm neonates with hemolytic disease of newborn.\n\nObjectives: The investigators aimed to compare the safety of implementing low-threshold, compared to high- threshold, of TSB for phototherapy interruption in term and late preterm neonates with hemolytic disease of newborn.', 'detailedDescription': 'Neonates in high-threshold group phototherapy will be ceased if TSB level is 50-100 µmol/L below the appropriate 2004 AAP phototherapy threshold, whereas neonates in the low-threshold group phototherapy will be stopped if TSB reached ˃100 µmol/L below the AAP threshold.\n\nPhototherapy will be commenced for neonates in both groups according to AAP guidelines.Neonates will be treated with intensified overhead blue LEDs phototherapy if they have a TSB level at or above phototherapy threshold. Neonates will be started on intensified 360◦ LED phototherapy if they have TSB level within 50µmol/L below the exchange threshold. The administration of IVIG is indicated in infants with isoimmune hemolytic disease if TSB lies within 34 to 51 micromol/L of the threshold for exchange transfusion and not responding to initial intensified phototherapy.Infants with a TSB concentration above the thresholds for exchange should have immediate intensified 360◦ LED phototherapy, and preparation for exchange transfusion will be started.Infants showed clinical signs of acute bilirubin encephalopathy will have an immediate exchange transfusion.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Days', 'minimumAge': '1 Hour', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nHealthy term and late-preterm neonates more than or equal 35 weeks gestation with hemolytic disease of newborn will be included. Enrolled infants should have evidence of hemolysis as defined by any of the following criteria:\n\n1. positive DAT and blood group iso-immunization (ABO / RH incompatibility);and /or\n2. HGB decline by 2g/dl within 24hour.\n\nExclusion Criteria:\n\n* Major congenital abnormalities,\n* Surgical problems,\n* Direct hyperbilirubinemia\n* Sepsis'}, 'identificationModule': {'nctId': 'NCT04218318', 'briefTitle': 'Safe Threshold to Discontinue Phototherapy in Hemolytic Disease of Newborn', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Ministry of Health, Saudi Arabia'}, 'officialTitle': 'Safe Threshold to Discontinue Phototherapy in Term and Late Preterm Infant With Hemolytic Disease of Newborn: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'H-03-M-084'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Low-threshold group', 'description': 'Neonates in the low-threshold group phototherapy will be stopped if TSB reached ˃100 µmol/L below the AAP phototherapy threshold.', 'interventionNames': ['Device: phototherapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'High-threshold group', 'description': 'Neonates in high-threshold group phototherapy will be ceased if TSB level is 50-100 µmol/L below the appropriate AAP phototherapy threshold.', 'interventionNames': ['Device: phototherapy']}], 'interventions': [{'name': 'phototherapy', 'type': 'DEVICE', 'description': 'Phototherapy will be commenced for neonates in both groups according to AAP guidelines.Neonates will be treated with intensified overhead blue LEDs phototherapy if they have a TSB level at or above phototherapy threshold. Neonates will be started on intensified 360◦ LED phototherapy if they have TSB level within 50µmol/L below the exchange threshold. The administration of IVIG is indicated in infants with isoimmune hemolytic disease if TSB lies within 34 to 51 micromol/L of the threshold for exchange transfusion and not responding to initial intensified phototherapy.Infants with a TSB concentration above the thresholds for exchange should have immediate intensified 360◦ LED phototherapy, and preparation for exchange transfusion will be started.Infants showed clinical signs of acute bilirubin encephalopathy will have an immediate exchange transfusion.', 'armGroupLabels': ['High-threshold group', 'Low-threshold group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '42319', 'city': 'Madinah', 'status': 'RECRUITING', 'country': 'Saudi Arabia', 'facility': "Madinah maternity and children's hospital", 'geoPoint': {'lat': 24.46861, 'lon': 39.61417}}], 'centralContacts': [{'name': 'Fatimah S Alhazmi, MD', 'role': 'CONTACT', 'email': 'f.alhazmi@hotmail.com', 'phone': '00 966 54 0564141'}], 'overallOfficials': [{'name': 'Fatimah S Alhazmi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ministry of Health, Saudi Arabia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ministry of Health, Saudi Arabia', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': "Cilinical fellow, Madinah Maternity and Children's Hospital, NICU", 'investigatorFullName': 'Fatema Sulaiman Alhazmi', 'investigatorAffiliation': 'Ministry of Health, Saudi Arabia'}}}}