Ignite Creation Date:
2025-12-24 @ 6:39 PM
Ignite Modification Date:
2025-12-28 @ 3:17 AM
Study NCT ID:
NCT05585957
Status:
UNKNOWN
Last Update Posted:
2022-10-19
First Post:
2022-10-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
THE VALUE OF INTERLEUKIN 6 AS A DIAGNOSTIC MARKER IN NEONATAL SEPSIS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-07-16', 'releaseDate': '2025-06-29'}], 'estimatedResultsFirstSubmitDate': '2025-06-29'}}, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-11-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2023-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-10-18', 'studyFirstSubmitDate': '2022-10-16', 'studyFirstSubmitQcDate': '2022-10-18', 'lastUpdatePostDateStruct': {'date': '2022-10-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'level of interleukin 6', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['NEONATAL SEPSIS']}, 'referencesModule': {'references': [{'pmid': '30924465', 'type': 'BACKGROUND', 'citation': 'Guo J, Luo Y, Wu Y, Lai W, Mu X. Clinical Characteristic and Pathogen Spectrum of Neonatal Sepsis in Guangzhou City from June 2011 to June 2017. Med Sci Monit. 2019 Mar 29;25:2296-2304. doi: 10.12659/MSM.912375.'}, {'pmid': '33866721', 'type': 'BACKGROUND', 'citation': 'Habib A, Raza S, Ali U, Zubairi AM, Salim E. Diagnostic Accuracy of Serum Procalcitonin (PCT) as an Early Biomarker of Neonatal Sepsis using Blood Culture as Gold Standard. J Coll Physicians Surg Pak. 2021 Apr;31(4):383-387. doi: 10.29271/jcpsp.2021.04.383.'}, {'pmid': '26993220', 'type': 'BACKGROUND', 'citation': 'Kan B, Razzaghian HR, Lavoie PM. An Immunological Perspective on Neonatal Sepsis. Trends Mol Med. 2016 Apr;22(4):290-302. doi: 10.1016/j.molmed.2016.02.001. Epub 2016 Mar 15.'}, {'pmid': '33209725', 'type': 'BACKGROUND', 'citation': 'Liu C, Fang C, He Q, Xie L. The value of interleukin-6 (IL-6) within 6 hours after birth in the prompt diagnosis of early-onset neonatal sepsis. Transl Pediatr. 2020 Oct;9(5):629-635. doi: 10.21037/tp-20-239.'}]}, 'descriptionModule': {'briefSummary': 'Neonatal sepsis is a leading cause of neonatal mortality and continues to be a formidable problem for neonatologists and pediatricians world over. The prevalence of neonatal sepsis varies in different countries; in developed countries it is 1 to 10 cases per 1000 live births and in developing countries the incidence of neonatal septicemia increases to 49 to 170 cases per 1000 live births. The normal fetus is sterile until shortly before birth as the placenta and amniotic sac are highly effective barriers to infections. At birth, the newborn loses the protection afforded to it in the uterus and gets exposed to the microbial world.Neonatal sepsis is broadly divided into two types according to age of onset: Early-onset sepsis (\\<72 Hrs) and late-onset sepsis (≥72 hrs-28 days). Early-onset sepsis is acquired during fetal life, delivery, or at the nursery.Bacterial organisms causing NS may differ among countries, however, in most developing countries, gram-negative bacteria remain the major source of infection.To date, blood culture is the gold standard test for diagnosing sepsis, but it has some inherent limitations. It takes at least three or five days to be decisive and can be mistakenly negative because antibiotics are initiated empirically before collection and a well-developed microbiology laboratory is required.CRP is one of the most widely studied and applied acute phase proteins clinically, which can be induced by pre-inflammatory factor interleukin-6 (IL-6) to synthesize by liver cells, and it starts to rise in 12-24 hours of inflammatory response and reaches its peak at 48 hours.Interleukin-6 (IL-6) is a pleiotropic cytokine expressed by different cells in response to infections.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '3 Months', 'minimumAge': '1 Hour', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Neonates admitted to our hospital NICU with fever, poor feeding and irritability whom suspected to have neonatal sepsis.\n\nExclusion Criteria:\n\n* Normal white blood cell count, patients whom on antibiotic therapy, negative blood culture'}, 'identificationModule': {'nctId': 'NCT05585957', 'briefTitle': 'THE VALUE OF INTERLEUKIN 6 AS A DIAGNOSTIC MARKER IN NEONATAL SEPSIS', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'THE VALUE OF INTERLEUKIN 6 AS A DIAGNOSTIC MARKER IN NEONATAL SEPSIS', 'orgStudyIdInfo': {'id': 'Soh-Med-22-10-08'}}, 'armsInterventionsModule': {'interventions': [{'name': 'INTERLEUKIN 6', 'type': 'DIAGNOSTIC_TEST', 'description': 'role of interleukin 6 in the diagnosis of neonatal sepsis in comparison with the routine diagnostic markers of neonatal sepsis'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Sohag', 'country': 'Egypt', 'contacts': [{'name': 'Magdy M Amin, Professor', 'role': 'CONTACT'}], 'facility': 'Sohag University hospitals', 'geoPoint': {'lat': 26.55695, 'lon': 31.69478}}], 'centralContacts': [{'name': 'Doha F Hamd-Allah, Resident', 'role': 'CONTACT', 'email': 'dohafaisel@med.sohag.edu.eg', 'phone': '01067567337'}, {'name': 'Ashraf K Mohammad, Assistant professor', 'role': 'CONTACT'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident of clinical and chemical pathology department, Sohag university hospital', 'investigatorFullName': 'Doha Faisal Hamdallah', 'investigatorAffiliation': 'Sohag University'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2025-06-29', 'type': 'RELEASE'}, {'date': '2025-07-16', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Doha Faisal Hamdallah, Resident of clinical and chemical pathology department, Sohag university hospital, Sohag University'}}}}