THE VALUE OF INTERLEUKIN 6 AS A DIAGNOSTIC MARKER IN NEONATAL SEPSIS
Primary Purpose
NEONATAL SEPSIS
Status
Not yet recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
INTERLEUKIN 6
Sponsored by
About this trial
This is an interventional diagnostic trial for NEONATAL SEPSIS
Eligibility Criteria
Inclusion Criteria:
- Neonates admitted to our hospital NICU with fever, poor feeding and irritability whom suspected to have neonatal sepsis.
Exclusion Criteria:
- Normal white blood cell count, patients whom on antibiotic therapy, negative blood culture
Sites / Locations
- Sohag University hospitals
Outcomes
Primary Outcome Measures
level of interleukin 6
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05585957
Brief Title
THE VALUE OF INTERLEUKIN 6 AS A DIAGNOSTIC MARKER IN NEONATAL SEPSIS
Official Title
THE VALUE OF INTERLEUKIN 6 AS A DIAGNOSTIC MARKER IN NEONATAL SEPSIS
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 1, 2022 (Anticipated)
Primary Completion Date
May 1, 2023 (Anticipated)
Study Completion Date
May 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sohag University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
NEONATAL SEPSIS
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Diagnostic Test
Intervention Name(s)
INTERLEUKIN 6
Intervention Description
role of interleukin 6 in the diagnosis of neonatal sepsis in comparison with the routine diagnostic markers of neonatal sepsis
Primary Outcome Measure Information:
Title
level of interleukin 6
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Hour
Maximum Age & Unit of Time
3 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
- Neonates admitted to our hospital NICU with fever, poor feeding and irritability whom suspected to have neonatal sepsis.
Exclusion Criteria:
Normal white blood cell count, patients whom on antibiotic therapy, negative blood culture
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Doha F Hamd-Allah, Resident
Phone
01067567337
Email
dohafaisel@med.sohag.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Ashraf K Mohammad, Assistant professor
Facility Information:
Facility Name
Sohag University hospitals
City
Sohag
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Magdy M Amin, Professor
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
30924465
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.
Results Reference
background
PubMed Identifier
33866721
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;30(4):383-387. doi: 10.29271/jcpsp.2021.04.383.
Results Reference
background
PubMed Identifier
26993220
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.
Results Reference
background
PubMed Identifier
33209725
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.
Results Reference
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THE VALUE OF INTERLEUKIN 6 AS A DIAGNOSTIC MARKER IN NEONATAL SEPSIS
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