Role of Neutrophil CD64 and Monocyte HLA-DR Markers in the Dignosis of Neonatal Sepsis

Neonatal Sepsis Clinical Trial

Official title:

Role of Neutrophil CD64 and Monocyte HLA-DR Markers in the Dignosis of Neonatal Sepsis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05985174
• Other study ID #: Soh-Med-23-07-13MS
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 1, 2023
• Est. completion date: August 1, 2024

Study information

• Verified date: August 2023
• Source: Sohag University
• Contact: Aya G Mostafa, Resident
• Phone: 01009389427
• Email: ayagamal[@]med.sohag.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Neonatal septicemia remains one of the main causes of neonatal morbidity and mortality . Sepsis which is caused by a dysregulated host response to an infectious trigger leading to a life threatening organ dysfunction was declared by the World Health Organization (WHO) on May 2017 as a global health priority that requires resolution for its prevention , dignosis , and management (Monneret et al., 2019). Despite the advances in perinatal and neonatal sepsis remains high and the outcome is still sever (Chirio et al.,2011) .

HLA-DR is on the surface of monocyte \ macrophages , dendritic cells, and B cells and plays a crucial role in adaptive immune response , More than 30 years ago , researches proved an association between the low level of HLA-DR and the development of sepsis (Cheadle at al .,1991) . A decreased expression of mHLA-DR molecules has been associated with immunoparalysis , which is an inflammatory immune responce that occurs in sepsis .(Pradhan et al.,2016).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: August 1, 2024
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Day to 28 Days

Eligibility

Inclusion Criteria:

• Neonates 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:

• are the adminstration of antibiotic therapy prior to admission , birth asphyxia , laboratory finding suggestive of inborn error of metabolism , and congenital anomalies including congenital heart diseases .

Related Conditions & MeSH terms

• Neonatal Sepsis
• Sepsis
• Toxemia

Intervention

Diagnostic Test:
• CD64 , HLA-DR
CD64 is atype of integral membrane glycoprotein , when activated , it increases the neutrophils' potential for phagocytosis and bacterial killing . HLA-DR is on the surface of monocyte\macrophages , dendritic cells and plays a crucial role in adaptive immune response

Locations

Country	Name	City	State
Egypt	Sohag University hospitals	Sohag

Sponsors (1)

Lead Sponsor	Collaborator
Sohag University

Country where clinical trial is conducted

Egypt, 

References & Publications (4)

Aydin M, Barut S, Akbulut HH, Ucar S, Orman A. Application of Flow Cytometry in the Early Diagnosis of Neonatal Sepsis. Ann Clin Lab Sci. 2017 Mar;47(2):184-190. — View Citation

Chirico G, Loda C. Laboratory aid to the diagnosis and therapy of infection in the neonate. Pediatr Rep. 2011 Feb 24;3(1):e1. doi: 10.4081/pr.2011.e1. — View Citation

Ng PC, Lam HS. Diagnostic markers for neonatal sepsis. Curr Opin Pediatr. 2006 Apr;18(2):125-31. doi: 10.1097/01.mop.0000193293.87022.4c. — View Citation

Vazquez Rodriguez S, Arriaga Pizano LA, Laresgoiti Servitje E, Mancilla Ramirez J, Peralta Mendez OL, Villalobos Alcazar G, Granados Cepeda ML, Hernandez Pelaez MG, Cordero Gonzalez G, Arizmendi Villanueva R, Cruz Ramirez JL, Isibasi A, Lopez Macias C, Flores Romo L, Jimenez Zamudio LA, Cerbulo-Vazquez A. Multiparameter flow cytometry analysis of leukocyte markers for diagnosis in preterm neonatal sepsis. J Matern Fetal Neonatal Med. 2021 Jul;34(14):2323-2333. doi: 10.1080/14767058.2019.1666100. Epub 2019 Sep 19. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CD64 from a peripheral blood sample measued by FlowCytometry device .	A cluster of differentiation 64 is a type of intergral membrane glycoprotein , when activated , it increases the neutrophil, potential for phagocytosis and bacterial killing .	12 months