Ignite Creation Date:
2025-12-24 @ 7:58 PM
Ignite Modification Date:
2025-12-25 @ 5:32 PM
Study NCT ID:
NCT07247604
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-25
First Post:
2025-11-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Congenital Heart Diseases and Developmental Assessment in Cholestatic Infants Under Two Years
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002779', 'term': 'Cholestasis'}, {'id': 'D006330', 'term': 'Heart Defects, Congenital'}], 'ancestors': [{'id': 'D001649', 'term': 'Bile Duct Diseases'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 106}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12-11', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-12-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-22', 'studyFirstSubmitDate': '2025-11-15', 'studyFirstSubmitQcDate': '2025-11-22', 'lastUpdatePostDateStruct': {'date': '2025-11-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frequency of CHDs among cholestatic infants', 'timeFrame': 'At initial clinical evaluation', 'description': 'Assessment of prevalence of congenital heart diseases in infants below 2 years with cholestasis.'}], 'secondaryOutcomes': [{'measure': 'Types of CHDs identified in cholestatic infants', 'timeFrame': 'During hospital evaluation', 'description': 'At baseline echocardiographic assessment'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cholestasis', 'Congenital Heart Disease']}, 'descriptionModule': {'briefSummary': "Congenital heart diseases (CHDs) are common in infants with cholestasis due to shared prenatal and metabolic factors. This study aims to determine the frequency and types of CHDs and to assess physical and mental development in children below two years with cholestasis at Assiut University Children's Hospital.", 'detailedDescription': 'Congenital heart diseases (CHDs) are the most common structural malformations in childhood, affecting approximately 8-12 per 1,000 live births worldwide. Infants with systemic disorders such as neonatal and infantile cholestasis have a higher prevalence of CHDs due to overlapping prenatal insults, genetic syndromes, and metabolic disturbances. Cholestasis, defined as impaired bile flow with conjugated hyperbilirubinemia, may arise from biliary atresia, neonatal hepatitis, or metabolic and syndromic disorders such as Alagille syndrome. Several studies highlight a strong association between cholestasis and CHDs, and early recognition of this dual burden is essential to improve outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '2 Years', 'minimumAge': '1 Month', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Infants with various causes of cholestatic disorders evaluated for congenital heart diseases and developmental outcomes.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children below 2 years presenting with cholestasis\n\nExclusion Criteria:\n\n* Prematurely born infants.'}, 'identificationModule': {'nctId': 'NCT07247604', 'briefTitle': 'Congenital Heart Diseases and Developmental Assessment in Cholestatic Infants Under Two Years', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': "Pattern of Congenital Heart Diseases and Developmental Evaluation in Children Below Two Years With Cholestasis at Assiut University Children's Hospital", 'orgStudyIdInfo': {'id': 'CHD-CHOLEST-ASSIUT'}}, 'contactsLocationsModule': {'centralContacts': [{'name': '\u202aShimaa Ahmed\u202c', 'role': 'CONTACT', 'email': 'shimaa01120432073@gmail.com', 'phone': '01120432073'}, {'name': 'Dalia Mahran', 'role': 'CONTACT', 'email': 'daliaym2001@yahoo.com', 'phone': '01007120821'}], 'overallOfficials': [{'name': 'Dalia Mahran Mohammed, Prof.', 'role': 'STUDY_CHAIR', 'affiliation': 'Professor of Family Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data will not be shared because the dataset contains sensitive clinical information about pediatric patients, and sharing is not permitted by the institutional ethics committee.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident, Family Medicine Department', 'investigatorFullName': 'Shimaa Ahmed Mahros', 'investigatorAffiliation': 'Assiut University'}}}}