Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2025-12-25 @ 9:30 PM
Study NCT ID:
NCT07152951
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-03
First Post:
2025-08-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Electrolytes Disturbance in Infant
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-26', 'studyFirstSubmitDate': '2025-08-26', 'studyFirstSubmitQcDate': '2025-08-26', 'lastUpdatePostDateStruct': {'date': '2025-09-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '1-Determine prevalence and types of electrolyte disturbances in infants and children with gastrointestinal diseases', 'timeFrame': 'From 1 Jan 2025 to 1 Jan 2026'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Electrolyte Disturbance in Gastrointestinal Diseases']}, 'descriptionModule': {'briefSummary': 'Prevalence of electrolyte disturbances in infants and children with gastrointestinal diseases', 'detailedDescription': 'Prevalence of electrolyte disturbances in infants and children with gastrointestinal diseases'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '4 Years', 'minimumAge': '1 Month', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All patients from one month till 4 years who will be admitted to Gastroenterology unit in (AUCH) and diagnosed with a gastrointestinal disease', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients from one month till 4 years who will be admitted to Gastroenterology unit in (AUCH) and diagnosed with a gastrointestinal disease\n\nExclusion Criteria:\n\n* 1-Neonates \\>1 month \\& those \\<4 years . 2-Patients with acute or chronic kidney diseases that alter electrolyte balance. 3-Patients with endocrine disorders affecting electrolyte balance (e.g adrenal insufficiency). 4-Use of medications that alter electrolyte balance (e.g diuretics, steroids). 5-Critically ill patients that electrolyte disturbance is due to non-gastrointestinal causes.'}, 'identificationModule': {'nctId': 'NCT07152951', 'briefTitle': 'Electrolytes Disturbance in Infant', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Prevalence of Electrolyte Disturbances in Infants and Children With Gastrointestinal Diseases', 'orgStudyIdInfo': {'id': 'AssuitUniversityAUH'}}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident doctor', 'investigatorFullName': 'Arwa Hosny Hammam Hasanien', 'investigatorAffiliation': 'Assiut University'}}}}