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

NCT05589909 | Unknown

• 1 other identifier: R.22.03.1667
• Study Type: observational
• Target: 548
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Early onset neonatal sepsis, Procalcitonin, Interleukin-27.

Outcome Measures

Primary Outcomes (1)

• Measurement of IL27, PCT and CRP levels in umbilical cord blood

  comparison between 2 groups

  6 months

Secondary Outcomes (1)

• Measurement of IL27, PCT and CRP levels in blood after 24 hours

  6 months

Study Arms (2)

Infection Group

Both suspected and confirmed sepsis occurred ≤72 hours after delivery were counted as cases of EONS.

Diagnostic Test: IL27, PCT, CRP, Blood culture

None Infection Group

No evidence clinical or laboratory of infection

Diagnostic Test: IL27, PCT, CRP, Blood culture

Interventions

IL27, PCT, CRP, Blood culture DIAGNOSTIC_TEST

magnetic bead multiplex platform

Infection Group; None Infection Group

Eligibility Criteria

• Age: 0 Minutes - 24 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

These risk factors included maternal fever, prolonged rupture of membranes with leaking amniotic fluid 18 hours or more before delivery, maternal bacterial infection including urinary tract infection or evidence of maternal colonization with group B streptococcus (GBS).

You may qualify if:

• All newborn infants born to pregnant women who had one or more of antenatal risk factors for sepsis. on or evidence of maternal colonization with group B streptococcus (GBS).

Sponsors & Collaborators

• Mansoura University Children Hospital: lead

Study Sites (1)

Mansoura University Children Hospital

Abu Dhabi, United Arab Emirates

RECRUITING

MeSH Terms

Conditions

Neonatal Sepsis

Interventions

Blood Culture

Condition Hierarchy (Ancestors)

Sepsis; Infections; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Microbiological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Central Study Contacts

wael seliem, MD

CONTACT

00971545873838; wseliem@hotmail.com

Amira Sultan, MD

CONTACT

+971507759539; amira110sultan@yahoo.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics and Neonatology

Study Record Dates

• First Submitted: June 12, 2022
• First Posted: October 21, 2022
• Study Start: June 20, 2022
• Primary Completion: October 22, 2022
• Study Completion: January 1, 2023
• Last Updated: October 21, 2022

Record last verified: 2022-10

Locations

AE (1)