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临床试验/NCT05985174
NCT05985174尚未招募不适用

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

Sohag University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2023年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
50
试验地点
1
主要终点
CD64 from a peripheral blood sample measued by FlowCytometry device .

研究概览

简要总结

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).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
1 Day 至 28 Days(Child)
性别
All
接受健康志愿者

入选标准

  • 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 ,

排除标准

  • 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 .

结局指标

主要结局

CD64 from a peripheral blood sample measued by FlowCytometry device .

时间窗: 12 months

A cluster of differentiation 64 is a type of intergral membrane glycoprotein , when activated , it increases the neutrophil, potential for phagocytosis and bacterial killing .

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Aya Gamal Mostafa

Resident of clinical and chemical pathology department, Sohag university hospital

Sohag University

研究点 (1)

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