Serum Presepsin as Early Predictor for Neonatal Early-onset Sepsis

N/ACompletedNCT05022043

Tanta University124 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Enrollment

124

Conditions

Neonatal Sepsis

Interventions

Serum PresepsinDIAGNOSTIC_TEST

Estimation of Serum Presepsin at time of admission

Eligibility

Sex: ALLMin age: 1 DayMax age: 7 Days

Medical Language ↔ Plain English

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.

Locations (1)

Tanta university

Tanta, Egypt

Outcomes

Primary Outcomes

prediction of neonatal outcome

Ability of Serum Presepsin to disseminate neonates with confirmed EOS

Time frame: one week

Data from ClinicalTrials.gov

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