Serum Presepsin as Early Predictor for Neonatal Early-onset Sepsis

At Admission Serum Presepsin as Early Predictor for Disease Severity and Positive Blood Culture for Neonates With Early-onset Sepsis

124 neonates aged ≤7 days with suspected EOS were clinically evaluated using SNAP-II and gave blood samples for BC, total leucocytic count (TLC), lymphocytic and neutrophil count, and ELISA estimation of serum levels of PSP, procalcitonin (PCT), and tumor necrosis factor-α (TNF-α). Enrolled neonates were categorized as Confirmed EOS: neonates with evident clinical sepsis manifestations and positive BC, Suspected EOS: neonates with evident clinical sepsis manifestations but had negative BC and No EOS included neonates free of evident clinical sepsis manifestations, had negative BC and showed no deterioration till 72-hr after admission.

Study Overview

• Status: Completed
• Conditions: Neonatal Sepsis
• Intervention / Treatment: Diagnostic test: Serum Presepsin

• Study Type: Interventional
• Enrollment (Actual): 124
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Tanta, Egypt
    • Tanta University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 1 week (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• included gestational age (GA) of 28-41 weeks and 5-min APGAR score of ≥7, and neonatal age of <7 days

Exclusion Criteria:

• including small for gestational age, presence of a chromosomal abnormality, multiple congenital anomalies, genetic syndromes, history of premature rupture of membranes, chorioamnionitis, neonatal asphyxia, and missed inclusion criterion.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: EOS	Diagnostic test: Serum Presepsin; Estimation of Serum Presepsin at time of admission
No Intervention: NO-EOS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
prediction of neonatal outcome	Ability of Serum Presepsin to disseminate neonates with confirmed EOS	one week

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2019
• Primary Completion (Actual): December 30, 2020
• Study Completion (Actual): June 15, 2021

Study Registration Dates

• First Submitted: August 21, 2021
• First Submitted That Met QC Criteria: August 21, 2021
• First Posted (Actual): August 26, 2021

Study Record Updates

• Last Update Posted (Actual): August 26, 2021
• Last Update Submitted That Met QC Criteria: August 21, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Presepsin; Blood culture; Early-onset neonatal sepsis; Clinical scoring; Early predictors
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Infant, Newborn, Diseases; Sepsis; Toxemia; Neonatal Sepsis
• Other Study ID Numbers: 34817/7/21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No