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Search / Trial NCT06633770

Role of Presepsin as a Novel Biomarker in Diagnosis of Neonatal Sepsis

Launched by SOHAG UNIVERSITY · Oct 7, 2024

Trial Information

Current as of June 26, 2025

Not yet recruiting

Keywords

ClinConnect Summary

This clinical trial is investigating a new test called presepsin, which may help doctors diagnose neonatal sepsis more accurately. Neonatal sepsis is a serious condition that occurs when newborns get infections, and it can be difficult to identify because the signs and symptoms are often vague. Currently, doctors rely on other tests, but these can sometimes be misleading. The goal of this study is to see if measuring levels of presepsin in the blood can provide a clearer picture of whether a newborn has sepsis.

The trial is looking for newborns up to 1 month old who show signs of possible sepsis, especially those with certain risk factors related to their mothers during pregnancy, such as prolonged labor or fever. However, babies who have received antibiotics before coming into the study or have certain congenital conditions will not be eligible. If a baby participates, they will undergo a blood test to check for presepsin levels. This study is important because it could lead to better and faster diagnoses, ultimately improving treatment and outcomes for these vulnerable infants.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Neonates from 0 to 1 month of age of both sexes included in this study with any suspected case of neonatal sepsis with maternal risk factors for sepsis, e.g., ( prolonged labor, premature rupture of membrane (PROM), maternal intrapartum fever and chorioamnionitis,) and neonates with sepsis-related clinical signs: (temperature instability, apnea, need for supplemental oxygen, bradycardia, tachycardia, hypotension, hypoperfusion, feeding intolerance, and abdominal distension).
  • Exclusion Criteria:
  • Administration of antibiotic therapy prior to admission, Birth asphyxia Laboratory finding suggestive of inborn error of metabolism Congenital anomalies including congenital heart disease

About Sohag University

Sohag University is a distinguished academic institution located in Sohag, Egypt, committed to advancing healthcare through rigorous clinical research. As a clinical trial sponsor, the university leverages its robust infrastructure and multidisciplinary expertise to facilitate innovative studies aimed at improving patient outcomes and contributing to the global body of medical knowledge. With a focus on ethical standards and scientific integrity, Sohag University collaborates with healthcare professionals and researchers to conduct trials that address critical health issues, ensuring the advancement of evidence-based practices in the healthcare community.

Locations

Sohag, , Egypt

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported