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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05022043
Enrollment
124
Registered
2021-08-26
Start date
2019-03-01
Completion date
2021-06-15
Last updated
2021-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neonatal Sepsis

Keywords

Early-onset neonatal sepsis, Presepsin, Clinical scoring, Early predictors, Blood culture

Brief 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.

Interventions

DIAGNOSTIC_TESTSerum Presepsin

Estimation of Serum Presepsin at time of admission

Sponsors

Tanta University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
1 Days to 7 Days
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
prediction of neonatal outcomeone weekAbility of Serum Presepsin to disseminate neonates with confirmed EOS

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026