NCT06633770

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

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Sohag University · Academic / Other
• Sex: All
• Age: 1 Day – 1 Month
• Healthy volunteers: Accepted

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.

Conditions

• Neonatal Sepsis

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	proclcitonin and presepsin	All included patients will be subjected to: * laboratory investigations * Complete Blood Count (CBC), * Liver Function Test(LFT) ( ALT,AST, Billirubin, total protein and albumin) * Kidney function test (KFT) ( Urea and creatinine) * Random Blood Glucose (RBG). * Erythrocyte Sedimentation Rate(ESR ) * Urine analysis -A special investigations include (blood culture, C Reactive protein (CRP), proclcitonin and presepsin).

Timeline

• Start date: 2024-12-01
• Primary completion: 2027-12-30
• Completion: 2028-01-30
• First posted: 2024-10-09
• Last updated: 2024-10-09

Locations

1 site across 1 country: Egypt