Ignite Creation Date:
2025-12-24 @ 3:16 PM
Ignite Modification Date:
2026-04-24 @ 1:09 AM
Study NCT ID:
NCT03074292
Status:
UNKNOWN
Last Update Posted:
2017-03-08
First Post:
2017-02-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison Between Effect of Conventional, Intensive and Light Emitting Diodes (LED) Phototherapy on Oxidative Stress Among Neonates With Unconjugated Hyperbilirubinemia
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2013-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2017-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-03-07', 'studyFirstSubmitDate': '2017-02-16', 'studyFirstSubmitQcDate': '2017-03-07', 'lastUpdatePostDateStruct': {'date': '2017-03-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effect of types of phototherapy on change in total antioxidant capacity (TAC)', 'timeFrame': '2 days', 'description': 'This will be determined by:\n\n1. Measure TAC (mmol/L) before and after phototherapy\n2. Compare results of TAC (mmol/L) before and after phototherapy.'}, {'measure': 'Effect of types of phototherapy on change in malonaldehyde (MDA)', 'timeFrame': '2 days', 'description': 'This will be determined by:\n\n1. Measure MDA (nmol/L) before and after phototherapy\n2. Compare results of MDA (nmol/L) before and after phototherapy.'}, {'measure': 'Effect of types of phototherapy on change in nitric oxide (NO)', 'timeFrame': '2 days', 'description': 'This will be determined by:\n\n1. Measure NO (umol/L) before and after phototherapy\n2. Compare results of NO (umol/L) before and after phototherapy.'}], 'secondaryOutcomes': [{'measure': 'Effect of types of phototherapy on change in serum iron (Fe)', 'timeFrame': '2 days', 'description': 'This will be determined by:\n\n1. Measure serum Fe before and after phototherapy\n2. Compare results of serum Fe before and after phototherapy.'}, {'measure': 'Effect of types of phototherapy on change in serum copper (Cu)', 'timeFrame': '2 days', 'description': 'This will be determined by:\n\n1. Measure serum Cu before and after phototherapy\n2. Compare results of serum Cu before and after phototherapy.'}, {'measure': 'Effect of types of phototherapy on change in serum zinc (Zn)', 'timeFrame': '2 days', 'description': 'This will be determined by:\n\n1. Measure serum Zn before and after phototherapy\n2. Compare results of serum Zn before and after phototherapy.'}, {'measure': 'Effect of types of phototherapy on change in serum calcium (Zn)', 'timeFrame': '2 days', 'description': 'This will be determined by:\n\n1. Measure serum Ca before and after phototherapy\n2. Compare results of serum Ca before and after phototherapy.'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Oxidative Stress', 'Neonatal Hyperbilirubinemia', 'Phototherapy Complication']}, 'referencesModule': {'references': [{'pmid': '30458636', 'type': 'DERIVED', 'citation': 'El-Farrash RA, El-Shimy MS, Tawfik S, Nada AS, Salem DAD, M Gallo MS, Abd-Elmohsen EW. Effect of phototherapy on oxidant/antioxidant status: a randomized controlled trial. Free Radic Res. 2019 Feb;53(2):179-186. doi: 10.1080/10715762.2018.1549364. Epub 2019 Mar 1.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the present study is to test a hypothesis assuming that phototherapy might have an effect on oxidant/antioxidant status in term and late-preterm neonates with unconjugated hyperbilirubinemia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '28 Days', 'minimumAge': '2 Days', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Term and late-preterm neonates (≥35weeks) according to the guidelines of the American Academy of Pediatrics (2004) which stated that gestational ages of newborns were determined according to the first day of the mother's last menstrual period (by the mother's statement) and were additionally confirmed by the Ballard scoring system (Ballard et al., 1991) and antenatal ultrasonographic estimation or obstetric records if present.\n* Clinical significant indirect hyperbilirubinemia requiring phototherapy in the first week of life.\n* Normal blood counts and peripheral blood smears\n* Normal reticulocytic count.\n* Breast fed newborn.\n\nExclusion Criteria:\n\n* Those in whom the total serum bilirubin (TSB) level rose by more than 5 mg/dl per day or was higher than 20 mg/dl within the first 24 hours after birth were excluded from the study.\n* Infant of diabetic mothers.\n* Maternal eclampsia-preeclampsia.\n* Birth asphyxia\n* Sepsis\n* congenital anomalies.\n* Direct Coombs'test positive\n* Pathological causes of hyperbilirubinemia.\n* Enclosed hemorrhage.\n* Hemolytic type of hyperbilirubinemia due to blood group or Rh incompatibility."}, 'identificationModule': {'nctId': 'NCT03074292', 'briefTitle': 'Comparison Between Effect of Conventional, Intensive and Light Emitting Diodes (LED) Phototherapy on Oxidative Stress Among Neonates With Unconjugated Hyperbilirubinemia', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'orgStudyIdInfo': {'id': '00006444'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'conventional phototherapy', 'description': 'neonates with unconjugated hyperbilirubinemia exposed to conventional phototherapy', 'interventionNames': ['Procedure: phototherapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'extensive phototherapy', 'description': 'neonates with unconjugated hyperbilirubinemia exposed to extensive phototherapy', 'interventionNames': ['Procedure: phototherapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'LED phototherapy', 'description': 'neonates with unconjugated hyperbilirubinemia exposed to LED phototherapy', 'interventionNames': ['Procedure: phototherapy']}], 'interventions': [{'name': 'phototherapy', 'type': 'PROCEDURE', 'description': 'estimate oxidative stress and trace elements in neonates with unconjugated hyperbilirubinemia after exposure to phototherapy', 'armGroupLabels': ['LED phototherapy', 'conventional phototherapy', 'extensive phototherapy']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rania Ali El-Farrash', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant professor', 'investigatorFullName': 'Rania Ali El-Farrash', 'investigatorAffiliation': 'Ain Shams University'}}}}