Back to resultsSerum Presepsin as Early Predictor for Neonatal Early-onset Sepsis
Primary Purpose
Neonatal Sepsis
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Serum Presepsin
Sponsored by
About this trial
This is an interventional diagnostic trial for Neonatal Sepsis focused on measuring Early-onset neonatal sepsis, Presepsin, Clinical scoring, Early predictors, Blood culture
Eligibility Criteria
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.
Sites / Locations
- Tanta university
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
EOS
NO-EOS
Arm Description
Outcomes
Primary Outcome Measures
prediction of neonatal outcome
Ability of Serum Presepsin to disseminate neonates with confirmed EOS
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05022043
Brief Title
Serum Presepsin as Early Predictor for Neonatal Early-onset Sepsis
Official Title
At Admission Serum Presepsin as Early Predictor for Disease Severity and Positive Blood Culture for Neonates With Early-onset Sepsis
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
December 30, 2020 (Actual)
Study Completion Date
June 15, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neonatal Sepsis
Keywords
Early-onset neonatal sepsis, Presepsin, Clinical scoring, Early predictors, Blood culture
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Non-Randomized
Enrollment
124 (Actual)
8. Arms, Groups, and Interventions
Arm Title
EOS
Arm Type
Active Comparator
Arm Title
NO-EOS
Arm Type
No Intervention
Intervention Type
Diagnostic Test
Intervention Name(s)
Serum Presepsin
Intervention Description
Estimation of Serum Presepsin at time of admission
Primary Outcome Measure Information:
Title
prediction of neonatal outcome
Description
Ability of Serum Presepsin to disseminate neonates with confirmed EOS
Time Frame
one week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
7 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Tanta university
City
Tanta
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
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Serum Presepsin as Early Predictor for Neonatal Early-onset Sepsis
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