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临床试验/NCT06626880
NCT06626880尚未招募不适用

Predictive Value of Scoring System in Neonates with Disseminated Intravascular Coagulation

Assiut University0 个研究点目标入组 43 人开始时间: 2025年1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
43
主要终点
The aims of this study were to investigate underlying diseases associated with neonatal DIC diagnosed on the first 28 days of life

研究概览

简要总结

The aims of this study were to investigate underlying diseases associated with neonatal DIC diagnosed on the first 28 days of life, and whether DIC score could predict mortality in neonates.

详细描述

Disseminated intravascular coagulation (DIC) is a syndrome caused by the activation of blood coagulation, in which systemic intravascular micro thromboses result in multiple organ failure and severe bleeding due to consumption of platelets and coagulation factors [1]. Compared with adults, neonates have an immature coagulation-fibrinolysis system and are prone to complications that cause DIC, such as hypoxia, acidosis, and infection [2]. Additionally, preterm infants have a lower hemostatic profile than term infants, which increases their risk of DIC [3]. However, gold standard interventions and treatments for DIC are lacking in neonatal medicine, Veldman et al. suggested that DIC in neonates is caused by prenatal risk factors such as placental abruption (PA), pregnancy induced hypertension (PIH), and neonatal factors such as sepsis, asphyxia, and interventricular hemorrhage (IVH), along with postnatal factors, such as necrotizing enterocolitis, gastrointestinal perforation, and infection [4]. The Japan Society of Obstetrical, Gynecological & Neonatal Hematology (JSOGNH) revised its diagnostic guidelines for neonatal DIC in 2016 and proposed a DIC scoring system [5]. Anticoagulant therapy, such as antithrombin administration and fresh frozen plasma (FFP), has been used to treat neonatal DIC [6]. Since 2008, recombinant human soluble thrombomodulin (rTM) has emerged as a novel anticoagulant for DIC in Japan [7]. Reversal of the underlying condition is paramount in achieving treatment success in the newborn with DIC. Strategies such as early antibiotic therapy and identification and control of the source of disease in cases of necrotizing enterocolitis, sepsis, and septic shock should always precede interventions directed at normalizing the coagulation system [8]. reports are lacking about diseases associated with neonatal DIC and whether anything predicts mortality in this context. We discuss the clinical andlaboratory criteria using (JSOGNH) scoring system to see if DIC score could predict mortality in neonates.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

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

入选标准

  • age at enrollment from the first day of life to 28 days of life.
  • Neonates diagnosed as DIC.

排除标准

  • Neonates born to mothers with ITP.
  • Autoimmune thrombocytopenic patients.

结局指标

主要结局

The aims of this study were to investigate underlying diseases associated with neonatal DIC diagnosed on the first 28 days of life

时间窗: from 1/1/2025 to 1/1/2026.

whether DIC score could predict mortality in neonates

时间窗: from 1/1/2025 to 1/1/2026.

The aims of this study were to investigate underlying diseases associated with neonatal DIC diagnosed on the first 28 days of life, and whether DIC score could predict mortality in neonates.

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

Mohamed Mostafa Bakr Sleem

Resident Doctor of pediatric

Assiut University

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