Ignite Creation Date:
2025-12-24 @ 4:31 PM
Ignite Modification Date:
2025-12-30 @ 1:00 AM
Study NCT ID:
NCT04723966
Status:
UNKNOWN
Last Update Posted:
2021-01-26
First Post:
2021-01-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy Evaluation of TPN in Preterm Neonates in NICU of Cairo University Children Hospital
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-04-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2021-12-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-01-21', 'studyFirstSubmitDate': '2021-01-21', 'studyFirstSubmitQcDate': '2021-01-21', 'lastUpdatePostDateStruct': {'date': '2021-01-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'electrolyte and mineral disturbance associated with TPN in preterm receiving it', 'timeFrame': '14 days', 'description': 'NA, K, MG, P, CA.'}], 'secondaryOutcomes': [{'measure': 'prevalence of cholestasis and sepsis in preterm receiving TPN', 'timeFrame': '14 days', 'description': 'clinical and laboratory examination'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['TPN in Preterm']}, 'descriptionModule': {'briefSummary': 'The aim of this work is evaluation of electrolytes and minerals homeostasis and occurrence of complications among preterm babies receiving total parenteral nutrition, and admitted to the neonatal intensive care units of Cairo University Children hospitals.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '1 Month', 'minimumAge': '1 Day', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This study will include all male and female preterm infants receiving total parenteral nutrition in NICU of Cairo university Children hospital', 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- All preterm infants with gestational age \\< 34 weeks, Receiving total parenteral nutrition. Normal serum magnesium.\n\nExclusion Criteria:\n\n* Any full-term neonates Any patient with TORCH infection, chromosomal, metabolic disorders or surgical abnormality of the hepatobiliary system'}, 'identificationModule': {'nctId': 'NCT04723966', 'briefTitle': 'Safety and Efficacy Evaluation of TPN in Preterm Neonates in NICU of Cairo University Children Hospital', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Safety and Efficacy Evaluation of TPN in Preterm Neonates in NICU of Cairo University Children Hospital', 'orgStudyIdInfo': {'id': 'MS- 110-2019'}}, 'armsInterventionsModule': {'interventions': [{'name': 'TPN', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Total parenteral nutrition'}]}, 'contactsLocationsModule': {'locations': [{'zip': '11562', 'city': 'Cairo', 'state': 'Almanyal', 'country': 'Egypt', 'facility': 'Faculty of Medicine', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'doctor', 'investigatorFullName': 'Khalid Mohammed Shehata', 'investigatorAffiliation': 'Cairo University'}}}}