Trials / Completed
CompletedNCT05022043
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
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 124 (actual)
- Sponsor
- Tanta University · Academic / Other
- Sex
- All
- Age
- 1 Day – 7 Days
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | Serum Presepsin | Estimation of Serum Presepsin at time of admission |
Timeline
- Start date
- 2019-03-01
- Primary completion
- 2020-12-30
- Completion
- 2021-06-15
- First posted
- 2021-08-26
- Last updated
- 2021-08-26
Locations
1 site across 1 country: Egypt
Source: ClinicalTrials.gov record NCT05022043. Inclusion in this directory is not an endorsement.