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

NCT05985174 | Unknown

• 1 other identifier: Soh-Med-23-07-13MS
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Neonatal Sepsis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

cases

EXPERIMENTAL

Neonates of both sexes included in this study with any suspected case of neonatal sepsis with maternal risk factors , e.g., prolonged labor , premature rupture of membrane (PROM) , maternal intrapartum fever and chorioamnionitis , and neonates with sepsis-related clinical signs :temparature instability , apnea , need for supplemental oxygen , bradycardia , tachycardia , hypotension , hypo perfusion , feeding intolerance , and abdominal distension .

Diagnostic Test: CD64 , HLA-DR

Interventions

CD64 , HLA-DR DIAGNOSTIC_TEST

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

cases

Eligibility Criteria

• Age: 1 Day - 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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 ,

You may not qualify if:

• 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 .

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag University hospitals

Sohag, Egypt

Location

Related Publications (4)

• 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.

  PMID: 21647274 BACKGROUND

• 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.

  PMID: 16601490 BACKGROUND

• 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.

  PMID: 31537145 BACKGROUND

• 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.

  PMID: 28442521 BACKGROUND

MeSH Terms

Conditions

Neonatal Sepsis

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

Central Study Contacts

Aya G Mostafa, Resident

CONTACT

01009389427; ayagamal@med.sohag.edu.eg

Laila M Yousef, Professor

CONTACT

01002976973

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of clinical and chemical pathology department, Sohag university hospital

Study Record Dates

• First Submitted: July 16, 2023
• First Posted: August 14, 2023
• Study Start: August 1, 2023
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: August 14, 2023

Record last verified: 2023-08

Locations

EG (1)