NCT05022043

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
124

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2019

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 21, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 26, 2021

Completed
Last Updated

August 26, 2021

Status Verified

August 1, 2021

Enrollment Period

1.8 years

First QC Date

August 21, 2021

Last Update Submit

August 21, 2021

Conditions

Neonatal Sepsis

Keywords

Early-onset neonatal sepsisPresepsinClinical scoringEarly predictorsBlood culture

Outcome Measures

Primary Outcomes (1)

  • prediction of neonatal outcome

    Ability of Serum Presepsin to disseminate neonates with confirmed EOS

    one week

Study Arms (2)

EOS

ACTIVE COMPARATOR
Diagnostic Test: Serum Presepsin

NO-EOS

NO INTERVENTION

Interventions

Serum PresepsinDIAGNOSTIC_TEST

Estimation of Serum Presepsin at time of admission

EOS

Eligibility Criteria

Age1 Day - 7 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • included gestational age (GA) of 28-41 weeks and 5-min APGAR score of ≥7, and neonatal age of \<7 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tanta university

Tanta, Egypt

Location

MeSH Terms

Conditions

Neonatal Sepsis

Condition Hierarchy (Ancestors)

SepsisInfectionsInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of pediatrics and neonatology

Study Record Dates

First Submitted

August 21, 2021

First Posted

August 26, 2021

Study Start

March 1, 2019

Primary Completion

December 30, 2020

Study Completion

June 15, 2021

Last Updated

August 26, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)