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

NCT06633770 | Not Yet Recruiting

• 1 other identifier: soh-Med-24-09-11MS
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Neonatal Sepsis

Outcome Measures

Primary Outcomes (1)

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

  4 years

Study Arms (2)

(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

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

Interventions

proclcitonin and presepsin DIAGNOSTIC_TEST

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).

(case group):; control group

Eligibility Criteria

• Age: 1 Day - 1 Month
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag university Hospital

Sohag, Sohag, Egypt

Location

Related Publications (5)

• Strunk T, Molloy EJ, Mishra A, Bhutta ZA. Neonatal bacterial sepsis. Lancet. 2024 Jul 20;404(10449):277-293. doi: 10.1016/S0140-6736(24)00495-1. Epub 2024 Jun 26.

  PMID: 38944044 BACKGROUND

• Pospisilova I, Brodska HL, Bloomfield M, Borecka K, Janota J. Evaluation of presepsin as a diagnostic tool in newborns with risk of early-onset neonatal sepsis. Front Pediatr. 2023 Jan 9;10:1019825. doi: 10.3389/fped.2022.1019825. eCollection 2022.

  PMID: 36699313 BACKGROUND

• Wei S, Shen Z, Yin Y, Cong Z, Zeng Z, Zhu X. Advances of presepsin in sepsis-associated ARDS. Postgrad Med J. 2024 Mar 18;100(1182):209-218. doi: 10.1093/postmj/qgad132.

  PMID: 38147883 BACKGROUND

• Krack AT, Eckerle M, Mahajan P, Ramilo O, VanBuren JM, Banks RK, Casper TC, Schnadower D, Kuppermann N; Febrile Infant Working Group of the Pediatric Emergency Care Applied Research Network (PECARN). Leukopenia, neutropenia, and procalcitonin levels in young febrile infants with invasive bacterial infections. Acad Emerg Med. 2024 Sep;31(9):903-914. doi: 10.1111/acem.14921. Epub 2024 Apr 25.

  PMID: 38661246 BACKGROUND

• Poggi C, Lucenteforte E, Petri D, De Masi S, Dani C. Presepsin for the Diagnosis of Neonatal Early-Onset Sepsis: A Systematic Review and Meta-analysis. JAMA Pediatr. 2022 Aug 1;176(8):750-758. doi: 10.1001/jamapediatrics.2022.1647.

  PMID: 35639395 BACKGROUND

MeSH Terms

Conditions

Neonatal Sepsis

Condition Hierarchy (Ancestors)

Sepsis; Infections; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Sara s saleh, resident

CONTACT

01112164307; sara_saleh_post@med.sohag0edu0eg

ahmed s sedky, assistant professor

CONTACT

01001856908

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: resident-clinical pathology sohag university hospital

Study Record Dates

• First Submitted: October 2, 2024
• First Posted: October 9, 2024
• Study Start: December 1, 2024
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): January 30, 2028
• Last Updated: October 9, 2024

Record last verified: 2024-10

Locations

EG (1)