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Performance of Interleukin-27 Cord Blood Level as A Biomarker Predicating Early Onset Neonatal Sepsis

NCT05589909 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 548

Last updated 2022-10-21

No results posted yet for this study

Summary

Neonatal sepsis still considered as one of the major causes of mortality and morbidity during the neonatal period due to high vulnerability of that age group. The blood culture is considered as the gold standard for diagnosis of bacterial sepsis, however in early onset neonatal sepsis (EONS) the inability to isolate a microbial pathogen does not exclude sepsis. The reason behind the high number of culture-negative cases is not clear and might be attributed to low levels of bacteremia or small volumes of blood obtained from sick infants. Also maternal antibiotic treatment before or during delivery may theoretically mask detection of bacteremia in the newborn. In addition these cultures have a 48-72 hours delay to obtain results. Therefore, the combination of clinical assessment and laboratory biomarkers currently are the bases for diagnosis of neonatal sepsis.

Recently interleukin-27 (IL-27) has been looked at as another candidate biomarker in the serum for diagnosis of sepsis in both adult and children. Interleukin-27 (IL-27), a novel member of the IL-12 family, was first discovered in 2002. IL- 27 is primarily synthesized by antigen-presenting cells, and it is widely expressed in a myriad of cells, including placental trophoblast cells. Although multiple studies have reported IL-27 as an essential regulator of immune response and inflammation, its precise role in the immune response is still disputable.

Conventionally, IL-27 has been envisaged as a potent promoter of inflammation. When first discovered, it was characterized as a promoting factor in the rapid initiation of inflammatory responses, processing the ability to stimulate the rapid expansion of naïve CD4+T and then the production of IFN-?, which has been demonstrated by various subsequent studies.

The aim of this study was to evaluate the usage of elevated IL-27 in cord blood as an early predictor biomarker for EONS.

Conditions

  • Neonatal Sepsis, Early-Onset

Interventions

DIAGNOSTIC_TEST

IL27, PCT, CRP, Blood culture

magnetic bead multiplex platform

Sponsors & Collaborators

  • Mansoura University Children Hospital

    lead OTHER

Eligibility

Min Age
0 Minutes
Max Age
24 Hours
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-20
Primary Completion
2022-10-22
Completion
2023-01-01

Countries

  • United Arab Emirates

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05589909 on ClinicalTrials.gov