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

NCT05585957 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2022-10-19

No results posted yet for this study

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.

Conditions

  • NEONATAL SEPSIS

Interventions

DIAGNOSTIC_TEST

INTERLEUKIN 6

role of interleukin 6 in the diagnosis of neonatal sepsis in comparison with the routine diagnostic markers of neonatal sepsis

Sponsors & Collaborators

  • Sohag University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Hour
Max Age
3 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-01
Primary Completion
2023-05-01
Completion
2023-05-01

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05585957 on ClinicalTrials.gov