THE VALUE OF INTERLEUKIN 6 AS A DIAGNOSTIC MARKER IN NEONATAL SEPSIS

Not Applicable

Not yet recruiting

• Conditions: NEONATAL SEPSIS

• Registration Number: NCT05585957
• Lead Sponsor: Sohag University

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2022-10
• Study First Submitted: 2022-10-16
• Study First Submitted QC: 2022-10-18
• Last Update Submitted: 2022-10-18
• Study First Posted: 2022-10-19
• Last Update Posted: 2022-10-19
• Study Start: 2022-11-01
• Primary Completion: 2023-05-01
• Study Completion: 2023-05-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Neonates admitted to our hospital NICU with fever, poor feeding and irritability whom suspected to have neonatal sepsis.

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Exclusion Criteria

• Normal white blood cell count, patients whom on antibiotic therapy, negative blood culture

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
level of interleukin 6	6 months

Trial Locations

Locations (1)

Sohag University hospitals; 🇪🇬 Sohag, Egypt