Ignite Creation Date:
2025-12-24 @ 4:52 PM
Ignite Modification Date:
2026-04-25 @ 2:03 PM
Study NCT ID:
NCT03354650
Status:
UNKNOWN
Last Update Posted:
2017-12-05
First Post:
2017-10-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Epidemiology of Neonatal Sepsis in Neonatal Intensive Care Unit in Assiut University Children Hospital
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000071074', 'term': 'Neonatal Sepsis'}], 'ancestors': [{'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000071997', 'term': 'Blood Culture'}], 'ancestors': [{'id': 'D008828', 'term': 'Microbiological Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'targetDuration': '12 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2019-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-12-03', 'studyFirstSubmitDate': '2017-10-28', 'studyFirstSubmitQcDate': '2017-11-26', 'lastUpdatePostDateStruct': {'date': '2017-12-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of neonatal sepsis', 'timeFrame': 'up to 4 months', 'description': 'by measuring the incidence of neonatal sepsis helping to know the size of the problem of neonatal sepsis'}, {'measure': 'prevalence of neonatal sepsis', 'timeFrame': 'up to 4 months', 'description': 'by measuring the prevalence of neonatal sepsis this help us to manage neonatal sepsis accordingly'}], 'secondaryOutcomes': [{'measure': 'risk factors and causative organisms of neonatal sepsis', 'timeFrame': 'up to 4 months', 'description': 'by determining the relation between risk factors and incidence of neonatal sepsis and by determining the causative organisms this help in prevention and management of neonatal sepsis'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Neonatal SEPSIS']}, 'descriptionModule': {'briefSummary': 'Neonatal sepsis is an important cause of morbidity and mortality in the pediatric age group . It is one of the leading causes of death in the first 28 days of life both in the developed and developing countries.', 'detailedDescription': 'More than 40% of under-five deaths globally occur in the neonatal period, resulting in 3.1 million newborn death each year.\n\nThe majority of these deaths usually occur in low income countries . On the other hand, the survivors of neonatal sepsis are vulnerable to short- and long term neurodevelopmental morbidity .\n\nNeonatal sepsis is a clinical syndrome characterized by signs and symptoms of infection with or without accompanying bacteremia in the first month of life. It includes various systemic infections of the newborn such as septicemia, meningitis, pneumonia, arthritis, osteomyelitis, and urinary tract infections. Superficial infections like conjunctivitis and oral thrush are usually not included under neonatal sepsis.\n\nDiagnosis of sepsis in neonates is challenging due to nonspecific signs and symptoms. The salient clinical features include systemic signs of infection such as fever, hypothermia, tachycardia, failure to thrive, lethargy, irritability, restlessness In addition, laboratory diagnosis until recently was time-consuming. This, therefore, necessitates the initiation of empirical antibiotic therapy pending a definitive diagnosis .\n\nNeonatal sepsis is caused by Gram-positive and Gram-negative bacteria and Candida. The diversity of organisms causing sepsis varies from region to another and changes over time even in the same place .'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '4 Weeks', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All admitted male and female infant from the birth to the day 30 after birth', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n• All admitted inborn and out born neonates during this study period will be screened for sepsis\n\nExclusion Criteria:\n\n• All cases that mimic neonatal sepsis such as;\n\n* Inborn errors of metabolism\n* Congestive heart failure\n* Hemolytic Disease of Newborn\n* Hypoxic ischemic encephalopathy\n* Congenital Diaphragmatic Hernia\n* Intra cranial hemorrhage\n* Respiratory Distress Syndrome'}, 'identificationModule': {'nctId': 'NCT03354650', 'briefTitle': 'Epidemiology of Neonatal Sepsis in Neonatal Intensive Care Unit in Assiut University Children Hospital', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Epidemiology of Neonatal Sepsis in Infants Admitted to Neonatal Intensive Care Unit in Assiut University Children Hospital', 'orgStudyIdInfo': {'id': 'EONI'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'complete blood count', 'description': 'blood sample is collected from infant to detect presence of sepsis', 'interventionNames': ['Diagnostic Test: blood culture']}, {'label': 'c reactive protein', 'description': 'measuring c reactive protein in blood sample to determine neonatal sepsis', 'interventionNames': ['Diagnostic Test: blood culture']}], 'interventions': [{'name': 'blood culture', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['other cultures if needed'], 'description': 'blood culture to determine causative organisms of neonatal sepsis', 'armGroupLabels': ['c reactive protein', 'complete blood count']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Ghan M Kamal El_Din, Professor', 'role': 'CONTACT', 'email': 'Gehankamal1958@gmail.com', 'phone': '00201013706184', 'phoneExt': 'Assiut'}, {'name': 'Ismael L Mohammed, Assistant Pr', 'role': 'CONTACT', 'email': 'ismail231@aun.edu.eg', 'phone': '00201063398967', 'phoneExt': 'Assiut'}], 'overallOfficials': [{'name': 'Gehan Mo Kamal El_Din, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Assiut University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'MSHAhmed', 'investigatorAffiliation': 'Assiut University'}}}}