Ignite Creation Date:
2025-12-24 @ 11:34 PM
Ignite Modification Date:
2025-12-25 @ 9:22 PM
Study NCT ID:
NCT06173856
Status:
COMPLETED
Last Update Posted:
2023-12-18
First Post:
2023-12-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effectiveness of Phototherapy With and Without Probiotics
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 76}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2023-01-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-14', 'studyFirstSubmitDate': '2023-12-07', 'studyFirstSubmitQcDate': '2023-12-14', 'lastUpdatePostDateStruct': {'date': '2023-12-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'effectiveness', 'timeFrame': '1 to 2 weeks', 'description': 'mean duration of phototherapy and the mean duration of hospital stay with and without probiotics for treatment of indirect hyerbilirubinemia in preterm neonates probiotics for the treatment of indirect hyperbilirubinemia in preterm neonates'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hyperbilirubinemia, Neonatal']}, 'descriptionModule': {'briefSummary': 'Raised serum bilirubin levels can cause kernicterus and premature infants are at increased risk due to metabolic immaturity. The standard treatment for neonatal jaundice is phototherapy but probiotics along with it can reduce the duration of phototherapy and hospitalization stay, secondarily can reduce the risk of nosocomial infection.', 'detailedDescription': 'Raised serum bilirubin levels can cause kernicterus and premature infants are at increased risk due to metabolic immaturity. The comparative analytical study was conducted after the ethical approval for one year (Jan 2022-Jan 2023) in the neonatal unit of The University of Lahore Teaching Hospital, Lahore, Pakistan. 76 preterm neonates fulfilling the selection criteria were included in the study and divided into two groups.\n\nStandard phototherapy was applied in both groups and group A probiotic (Saccharomyces boulardii) 125mg, twice daily, orally (in 5cc of milk whichever the baby was taking) was given till discharge from the hospital. The primary outcome measurements were the duration of phototherapy and the length of hospitalization.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '1 Week', 'minimumAge': '0 Hours', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All the Neonates with indirect hyperbilirubinemia,\n* Born at ;37 weeks of gestation\n* Both male and female neonates were included in the study\n\nExclusion Criteria:\n\n* Neonates with sepsis,\n* bilirubin level in exchange transfusion range\n* direct hyperbilirubinemia\n* Neonates with respiratory distress syndrome, severe birth asphyxia, intubated and critically sick'}, 'identificationModule': {'nctId': 'NCT06173856', 'briefTitle': 'Effectiveness of Phototherapy With and Without Probiotics', 'organization': {'class': 'OTHER', 'fullName': 'Fatima Jinnah Medical University'}, 'officialTitle': 'Effectiveness of Phototherapy With and Without Probiotics for the Treatment of Indirect Hyperbilirubinemia in Preterm Neonates', 'orgStudyIdInfo': {'id': 'KAU-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Phototherapy group', 'description': 'LED phototherapy (430-470nm)', 'interventionNames': ['Other: LED phototherapy']}, {'type': 'EXPERIMENTAL', 'label': 'phototherapy with probiotics group', 'description': 'In group B, LED phototherapy (430-470nm) with probiotics (125mg Saccharomyces boulardii, twice a day, orally mixed in 5cc of milk whichever the neonate is taking).', 'interventionNames': ['Other: LED phototherapy']}], 'interventions': [{'name': 'LED phototherapy', 'type': 'OTHER', 'description': 'LED phototherapy (430-470nm) alone will be applied.', 'armGroupLabels': ['Phototherapy group', 'phototherapy with probiotics group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54780', 'city': 'Lahore', 'country': 'Pakistan', 'facility': 'Humaira Waseem', 'geoPoint': {'lat': 31.558, 'lon': 74.35071}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'when results are compiled'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fatima Jinnah Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Naeem Afzal', 'investigatorAffiliation': 'Fatima Jinnah Medical University'}}}}