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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-12-01

Study Completion Date

2028-01-30

Brief Summary

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-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.

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Detailed Description

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Conditions

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Neonatal Sepsis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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(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:

proclcitonin and presepsin

Intervention Type 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).

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.

proclcitonin and presepsin

Intervention Type 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).

Interventions

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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).

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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

Minimum Eligible Age

1 Day

Maximum Eligible Age

1 Month

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes