Clinical trial NCT06633770: Role of Presepsin as a Novel Biomarker in Diagnosis of Neonatal Sepsis
Official title: Role of Presepsin as a Novel Biomarker in Diagnosis of Neonatal Sepsis
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Neonatal Sepsis
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2024-10-09
Enrollment: 100
Sex: ALL
Minimum age (years): 1
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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

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.


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

Primary outcomes:
measure: • The outcomes of interest for the analyses were presepsin sensitivity, specificity, and diagnostic odds ratio for the diagnosis of neonatal sepsis
timeFrame: 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag university Hospital
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.