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

Sohag University

Status: Not yet enrolling

Conditions: NEONATAL SEPSIS

Treatments: Diagnostic Test: INTERLEUKIN 6

Study type: Interventional

Funder types: Other

Identifiers

NCT05585957

Soh-Med-22-10-08

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 1 hour to 3 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)