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
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Neonatal Sepsis
• Sepsis
• Toxemia

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