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临床试验/NCT03403062
NCT03403062Unknown不适用

Prognostic Value of Red Cell Distribution Width (RDW) in Neonatal Sepsis in Patients Admitted at Assiut University Children Hospital.

Assiut University0 个研究点目标入组 100 人开始时间: 2019年2月最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
主要终点
the neonatal mortality rate .

研究概览

简要总结

  1. Evaluate the relationship of RDW and severity and mortality in patients with neonatal sepsis .
  2. Using RDW as a simple, inexpensive, applicable and rapid test to detect prognosis of neonatal sepsis .

详细描述

Sepsis is defined as a life-threatening condition caused by a dysregulated host response to infection. Sepsis is responsible for approximately 45% of neonatal emergencies and is a leading cause of neonatal mortality and morbidity, accounting for 14% of deaths in that age group.

The early symptoms and signs of neonatal sepsis are usually mild and nonspecific but can rapidly progress to septic shock, disseminated intravascular coagulation(DIC), and death. It is therefore of paramount importance to find a tool for prediction of infants who are more likely to experience a worse clinical outcome so that closer monitoring and more aggressive treatment would be offered to them.

Early-onset sepsis (EOS) is usually due to transplacental, ascending, or intrapartum transmission in the perinatal period shortly before or during birth, up to postnatal (PN) 7 days. Late-onset sepsis (LOS) is acquired by horizontal transmission in the home, hospital, or in the community after PN day.

Timely diagnosis and prompt institution of antimicrobial therapy are essential in order to mitigate the high case fatality and to avert morbidity associated with late-onset neonatal sepsis. In the latest years, biochemical markers are important in research areas in neonatal infections. Inflammatory cascade as response to an infection comprise many elevated markers, frequently used for diagnosis and monitoring of sepsis.

Numerous molecules have been studied as potentially useful prognostic markers in neonatal sepsis. These include C-reactive protein (CRP), procalcitonin, IL-6, IL-8, CD64, and soluble E- selectin.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
— 至 1 Month(Child)
性别
All
接受健康志愿者

入选标准

  • Any infant from birth to 1 month of age with a diagnosis of definite or probable sepsis will included in the study.

排除标准

  • gestational age less than 37 weeks.
  • perinatal asphyxia.
  • infants with more than 1 episode of sepsis, only the first one was included.
  • Infants with Dysmorphic features suggestive of chromosomal abnormalities.
  • neonates under a course of antibiotics prior to appropriate blood sampling.

结局指标

主要结局

the neonatal mortality rate .

时间窗: 30 day

Number of neonates died from sepsis .

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

mariam nagy gamil

Principal investigator

Assiut University

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