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临床试验/NCT05585957
NCT05585957尚未招募不适用

THE VALUE OF INTERLEUKIN 6 AS A DIAGNOSTIC MARKER IN NEONATAL SEPSIS

Sohag University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2022年11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
30
试验地点
1
主要终点
level of interleukin 6

研究概览

简要总结

Neonatal sepsis is a leading cause of neonatal mortality and continues to be a formidable problem for neonatologists and pediatricians world over. The prevalence of neonatal sepsis varies in different countries; in developed countries it is 1 to 10 cases per 1000 live births and in developing countries the incidence of neonatal septicemia increases to 49 to 170 cases per 1000 live births. The normal fetus is sterile until shortly before birth as the placenta and amniotic sac are highly effective barriers to infections. At birth, the newborn loses the protection afforded to it in the uterus and gets exposed to the microbial world.Neonatal sepsis is broadly divided into two types according to age of onset: Early-onset sepsis (<72 Hrs) and late-onset sepsis (≥72 hrs-28 days). Early-onset sepsis is acquired during fetal life, delivery, or at the nursery.Bacterial organisms causing NS may differ among countries, however, in most developing countries, gram-negative bacteria remain the major source of infection.To date, blood culture is the gold standard test for diagnosing sepsis, but it has some inherent limitations. It takes at least three or five days to be decisive and can be mistakenly negative because antibiotics are initiated empirically before collection and a well-developed microbiology laboratory is required.CRP is one of the most widely studied and applied acute phase proteins clinically, which can be induced by pre-inflammatory factor interleukin-6 (IL-6) to synthesize by liver cells, and it starts to rise in 12-24 hours of inflammatory response and reaches its peak at 48 hours.Interleukin-6 (IL-6) is a pleiotropic cytokine expressed by different cells in response to infections.

研究设计

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

入排标准

年龄范围
1 Hour 至 3 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Neonates admitted to our hospital NICU with fever, poor feeding and irritability whom suspected to have neonatal sepsis.

排除标准

  • Normal white blood cell count, patients whom on antibiotic therapy, negative blood culture

结局指标

主要结局

level of interleukin 6

时间窗: 6 months

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

Doha Faisal Hamdallah

Resident of clinical and chemical pathology department, Sohag university hospital

Sohag University

研究点 (1)

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