Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2025-12-26 @ 2:07 AM
Study NCT ID:
NCT05891405
Status:
UNKNOWN
Last Update Posted:
2023-06-06
First Post:
2023-05-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cardiac Surgery for Babies Less Than 5 kg:Risk Factors for Morbidity and Mortality
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D006348', 'term': 'Cardiac Surgical Procedures'}], 'ancestors': [{'id': 'D013504', 'term': 'Cardiovascular Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019616', 'term': 'Thoracic Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-07', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-05-28', 'studyFirstSubmitDate': '2023-05-28', 'studyFirstSubmitQcDate': '2023-05-28', 'lastUpdatePostDateStruct': {'date': '2023-06-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mortality', 'timeFrame': '1 month postoperative', 'description': 'Death after surgery'}], 'secondaryOutcomes': [{'measure': 'Morbidity', 'timeFrame': '1 month postoperative', 'description': 'Complications after surgery'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cardiac Surgery in Neonates']}, 'descriptionModule': {'briefSummary': 'Cardiac surgery in babies less than 6 kg of weight is a complex and high-risk procedure. Despite advances in medical technology, mortality and morbidity rates remain high. This study seeks to identify risk factors associated with mortality and morbidity in this population'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '2 Years', 'minimumAge': '1 Day', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Neonates with congenital heart diseases undergoing surgery for complete or partial treatment with body weight less than 5 kg at time of surgery', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* neonates undergoing surgery for congenital heart diseases\n\nExclusion Criteria:\n\n* larger body weights than 5 kg'}, 'identificationModule': {'nctId': 'NCT05891405', 'briefTitle': 'Cardiac Surgery for Babies Less Than 5 kg:Risk Factors for Morbidity and Mortality', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'Cardiac Surgery for Babies Less Than 5 kg:Risk Factors for Morbidity and Mortality', 'orgStudyIdInfo': {'id': 'Soh-Med-23-05-02MD'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Cardiac surgery', 'type': 'PROCEDURE', 'description': 'Operations for congenital heart diseases'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant lecturer', 'investigatorFullName': 'Ahmed Atef Ahmed', 'investigatorAffiliation': 'Sohag University'}}}}