Skip to main content
Clinical Trials/NCT06633770
NCT06633770
Not yet recruiting
Not Applicable

Role of Presepsin as a Novel Biomarker in Diagnosis of Neonatal Sepsis

Sohag University1 site in 1 country100 target enrollmentDecember 1, 2024
ConditionsNeonatal Sepsis

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Neonatal Sepsis
Sponsor
Sohag University
Enrollment
100
Locations
1
Primary Endpoint
• The outcomes of interest for the analyses were presepsin sensitivity, specificity, and diagnostic odds ratio for the diagnosis of neonatal sepsis
Status
Not yet recruiting
Last Updated
last year

Overview

Brief Summary

-Introduction: Sepsis is a clinical syndrome that results from a deregulated inflammatory response to an infection. it is life-threatening entity causing millions of deaths worldwide, with variable clinical manifestations and poses difficulty in diagnosis and treatment. Early recognition of sepsis not only helps in the optimization of treatment but also improves the overall outcome.

Neonatal sepsis is generally considered a spectrum of disorders that result from infection by bacteria , viruses, fungi ,or parasites or the toxic products of these., It is characterized by nonspecific signs and symptoms so it is a conundrum of diagnostic and therapeutic challenges .The proof of infection is seldom encountered in practice, as the confirmatory microbial culture yield can be as low as 25-30%. Hence, clinicians often depend on commonly available biomarkers such as C-reactive Protein (CRP) and procalcitonin (PCT) for diagnosing infection. Even though helpful, these markers are fraught with errors and limitations There is an exigent need for a novel biomarker that can serve as a clear distinguisher of sepsis from other non-septic inflammatory conditions The role of presepsin as a biomarker of sepsis in children is still a matter of scientific inquiry.

CD14 is a co-receptor present on the surface of the monocyte/macrophage. It is a member of the Toll-like receptors (TLRs),with an ability to identify groups of ligands of both gram-positive and gram-negative pathogens CD14 exists in two forms namely membrane-bound (mCD14) and a soluble form (sCD14). The sCD14 has different subtypes that get released in circulation and acted upon by proteases and cathepsin D . The N terminal fragment of the sCD14-ST subtype is called presepsin.

Registry
clinicaltrials.gov
Start Date
December 1, 2024
End Date
January 30, 2028
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Sara Saleh Ahmed

resident-clinical pathology sohag university hospital

Sohag University

Eligibility Criteria

Inclusion Criteria

  • Neonates from 0 to 1 month of age of both sexes included in this study with any suspected case of neonatal sepsis with maternal risk factors for sepsis, e.g., ( prolonged labor, premature rupture of membrane (PROM), maternal intrapartum fever and chorioamnionitis,) and neonates with sepsis-related clinical signs: (temperature instability, apnea, need for supplemental oxygen, bradycardia, tachycardia, hypotension, hypoperfusion, feeding intolerance, and abdominal distension).

Exclusion Criteria

  • Administration of antibiotic therapy prior to admission, Birth asphyxia Laboratory finding suggestive of inborn error of metabolism Congenital anomalies including congenital heart disease

Outcomes

Primary Outcomes

• The outcomes of interest for the analyses were presepsin sensitivity, specificity, and diagnostic odds ratio for the diagnosis of neonatal sepsis

Time Frame: 4 years

Study Sites (1)

Loading locations...

Similar Trials