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

Study Overview
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Brief Summary
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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).

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

Conditions
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Neonatal Sepsis

Intervention / Treatment
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* Diagnostic Test: CD64 , HLA-DR


Participation Criteria
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Eligibility Criteria
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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 .

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 28 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: cases<br>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<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |