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Serum Presepsin as Early Predictor for Neonatal Early-onset Sepsis

T

Tanta University

Status

Completed

Conditions

Neonatal Sepsis

Treatments

Diagnostic Test: Serum Presepsin

Study type

Interventional

Funder types

Other

Identifiers

NCT05022043
34817/7/21

Details and patient eligibility

About

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.

Enrollment

124 patients

Sex

All

Ages

1 to 7 days old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Diagnostic

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

124 participants in 2 patient groups

EOS
Active Comparator group
Treatment:
Diagnostic Test: Serum Presepsin
NO-EOS
No Intervention group

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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