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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05585957
Enrollment
30
Registered
2022-10-19
Start date
2022-11-01
Completion date
2023-05-01
Last updated
2022-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

NEONATAL SEPSIS

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.

Interventions

DIAGNOSTIC_TESTINTERLEUKIN 6

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

Sponsors

Sohag University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
1 Hours to 3 Months
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
level of interleukin 66 months

Countries

Egypt

Contacts

Primary ContactDoha F Hamd-Allah, Resident
dohafaisel@med.sohag.edu.eg01067567337
Backup ContactAshraf K Mohammad, Assistant professor

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026