Ignite Creation Date:
2025-12-24 @ 9:21 PM
Ignite Modification Date:
2026-01-02 @ 10:34 PM
Study NCT ID:
NCT06575504
Status:
COMPLETED
Last Update Posted:
2024-08-28
First Post:
2024-08-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ultrasonographical of Suprarenal Gland in High Risk Neonates
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 105}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-11-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2024-08-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-26', 'studyFirstSubmitDate': '2024-08-26', 'studyFirstSubmitQcDate': '2024-08-26', 'lastUpdatePostDateStruct': {'date': '2024-08-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adrenocortical insufficiency', 'timeFrame': '12 months', 'description': 'Blood flow velocity RI ED TMAX'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Doppler Ultrasound', 'Suprarenal gland', 'high risk neonates', 'NICU'], 'conditions': ['Insuffeciency of the Suprarenal Gland']}, 'referencesModule': {'availIpds': [{'url': 'https://guides.lib.umich.edu/datamanagement/clinicaltrials', 'type': 'Study Protocol'}]}, 'descriptionModule': {'briefSummary': 'Observation study The aim is to study the suprarenal blood flow among high-risk neonates and its relation to the risk factors', 'detailedDescription': 'Ultrasonographical study of the suprarenal gland in high risk newborn infants Al-Zhrraa University hospital Sample size 105 Inclusion criteria: 1- High-risk newborn 2- Need NICU admission Exclusion criteria: Cases with Major congenital anomalies and NEC Primary outcome: Abnormal suprarenal blood flow Informed consent will be obtained from all parents and mothers of the newborns enrolled in the study.\n\nAll cases will be subjected to - Full history taking: (prenatal -natal - postnatal). According to the routine admission sheet of NICU of Alzahraa University Hospital, Faculty of Medicine for girls, AL-Azhar University, Cairo, Egypt.\n\nThrough clinical examination (APGAR score -estimation of gestational age using modified Ballard score \\"Ballard, 1991\\" - body weight - severity of respiratory illness using Downs score and Silverman\\'s score).\n\nLaboratory investigations:\n\n* Blood gases.\n* Serum electrolytes and blood glucose.\n* CBC. CRP.\n* Liver and kidney functions. Radiological evaluation: in the form of Abdominal and chest x-ray. Ultrasonographical studies were done for suprarenal gland blood flow. - Statistical Analysis, Data were collected, revised, coded, and entered into the statistical package for social science (SPSS)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Days', 'minimumAge': '1 Day', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'neonates with high risk illness', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* High risk neonates\n\nExclusion Criteria:\n\n* congenital anomalies'}, 'identificationModule': {'nctId': 'NCT06575504', 'acronym': 'USSGneonates', 'briefTitle': 'Ultrasonographical of Suprarenal Gland in High Risk Neonates', 'organization': {'class': 'OTHER', 'fullName': 'Al-Azhar University'}, 'officialTitle': 'Ultrasonographical Study of Suprarenal Gland in High Risk Neonates', 'orgStudyIdInfo': {'id': 'AlAzharU'}, 'secondaryIdInfos': [{'id': '2462', 'type': 'OTHER', 'domain': 'AlAzharU'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Neonates', 'description': 'High risk newborn infants admitted to NICU', 'interventionNames': ['Diagnostic Test: Ultrasonographical examination']}], 'interventions': [{'name': 'Ultrasonographical examination', 'type': 'DIAGNOSTIC_TEST', 'description': 'Study size and Doppler / blood flow / of the suprarenal gland', 'armGroupLabels': ['Neonates']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11351', 'city': 'Cairo', 'state': 'Pediatrics/neonatology', 'country': 'Egypt', 'facility': 'Faculty of medicine for girls', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'ipdSharingStatementModule': {'url': 'https://guides.lib.umich.edu/datamanagement/clinicaltrials', 'infoTypes': ['STUDY_PROTOCOL', 'ICF', 'CSR'], 'timeFrame': '2 years', 'ipdSharing': 'YES', 'description': 'Used for results publications', 'accessCriteria': 'Journal authority'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Al-Azhar University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'safaa ELMeneza', 'investigatorAffiliation': 'Al-Azhar University'}}}}