Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2025-12-31 @ 9:45 PM
Study NCT ID:
NCT04313933
Status:
COMPLETED
Last Update Posted:
2020-03-18
First Post:
2020-03-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Plasma Citrulline in Preterm With NEC
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': 60}, 'targetDuration': '20 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-03-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2020-02-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-17', 'studyFirstSubmitDate': '2020-03-14', 'studyFirstSubmitQcDate': '2020-03-17', 'lastUpdatePostDateStruct': {'date': '2020-03-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'plasma citrulline as a marker of Necrotizing enterocolitis diagnosis', 'timeFrame': '1 Year', 'description': 'Compare plasma citrulline in NEC and comparing it with properly matched healthy neonates'}], 'secondaryOutcomes': [{'measure': 'Citrulline as a marker of intestinal recovery', 'timeFrame': '1 year', 'description': 'Follow up plasma citrulline level after initiation of feeding'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['NEC', 'Citrulline']}, 'descriptionModule': {'briefSummary': 'Aim of study', 'detailedDescription': 'Introduction'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '30 Days', 'minimumAge': '1 Day', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Preterm neonates admitted to NICU at Ain Shams Unversity Hospitals', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* preterm neonates \\< 35 weeks Preterm neonates\\< 2kg Preterm neonates diagnosed with necrotizing enterocolitis\n\nExclusion Criteria:\n\n* renal dysfunction Inborn error of metabolism Congenital malformation'}, 'identificationModule': {'nctId': 'NCT04313933', 'acronym': 'NEC', 'briefTitle': 'Plasma Citrulline in Preterm With NEC', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Plasma Citrulline in Preterm With NEC', 'orgStudyIdInfo': {'id': 'FMASU M S 419/2019'}}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'AinShams University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Amira Mostafa', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ain Shams University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Amira Mostafa', 'investigatorAffiliation': 'Ain Shams University'}}}}