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

October 7, 2024 updated by: Sara Saleh Ahmed, Sohag University

-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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: ahmed s sedky, assistant professor
  • Phone Number: 01001856908

Study Locations

  • Egypt
      • Sohag, Egypt, Sohag
        • Sohag University Hospital
        • Contact:
          • Magdy M Amin, professor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Neonates from 0 to 1 month of age of both sexes included in this study with any suspected case of neonatal sepsis

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
(case group):

Consists of 70 neonates, whose blood culture results were positive and indicative of known sepsis-causing pathogens and neonates whose clinical and laboratory findings were indicative of probable sepsis despite negative blood culture results.

Clinical and laboratory findings were indicative of probable sepsis :

  • Fever or low temperature.
  • Fast or slow heart rate.
  • Fast breathing or shortness of breath.
  • Vomiting.
  • Diarrhea.
  • Reduced sucking/difficulty feeding.
  • Swollen belly (abdomen).
  • Cold hands and feet.
  • Leukocyte (<5000 or ≥20000 wbcs/ µL), absolute neutrophil (>60%) a
  • Thrombocytopenia:
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).
control group
30 healthy neonates who had no signs of sepsis in clinical, radiographic, or laboratory findings or whose symptoms could be characteristic of another disease.
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
• 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
4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2024

Primary Completion (Estimated)

December 30, 2027

Study Completion (Estimated)

January 30, 2028

Study Registration Dates

First Submitted

October 2, 2024

First Submitted That Met QC Criteria

October 7, 2024

First Posted (Estimated)

October 9, 2024

Study Record Updates

Last Update Posted (Estimated)

October 9, 2024

Last Update Submitted That Met QC Criteria

October 7, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • soh-Med-24-09-11MS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Neonatal Sepsis

Clinical Trials on proclcitonin and presepsin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uzbekistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe