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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06633770
Enrollment
100
Registered
2024-10-09
Start date
2024-12-01
Completion date
2028-01-30
Last updated
2024-10-09

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

Conditions

Neonatal Sepsis

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.

Interventions

DIAGNOSTIC_TESTproclcitonin 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).

Sponsors

Sohag University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Days to 1 Months
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
• The outcomes of interest for the analyses were presepsin sensitivity, specificity, and diagnostic odds ratio for the diagnosis of neonatal sepsis4 years

Countries

Egypt

Contacts

Primary ContactSara s saleh, resident
sara_saleh_post@med.sohag0edu0eg01112164307
Backup Contactahmed s sedky, assistant professor
01001856908

Outcome results

None listed

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