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NCT05022043 Clinical Trial

Serum Presepsin as Early Predictor for Neonatal Early-onset Sepsis

Neonatal Sepsis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05022043
Other study ID # 34817/7/21
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 1, 2019
Est. completion date June 15, 2021

Study information
Verified date August 2021
Source Tanta University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 124
Est. completion date June 15, 2021
Est. primary completion date December 30, 2020
Accepts healthy volunteers No
Gender All
Age group N/A to 7 Days
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Serum Presepsin
Estimation of Serum Presepsin at time of admission

Locations
Country Name City State
Egypt Tanta university Tanta

Sponsors (1)
Lead Sponsor Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary prediction of neonatal outcome Ability of Serum Presepsin to disseminate neonates with confirmed EOS one week
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