跳至主要内容
临床试验/NCT02872350
NCT02872350Unknown不适用

Prognostic Contribution of Abdominal Ultrasound in Necrotizing Enterocolitis in Preterm Infants Less Than 33SA.

Assistance Publique Hopitaux De Marseille2 个研究点 分布在 1 个国家目标入组 95 人开始时间: 2016年10月最近更新:
适应症

试验速览

阶段
不适用
入组人数
95
试验地点
2
主要终点
Comment prognostic evaluation by abdominal ultrasound

研究概览

简要总结

Enterocolitis necrotizing (ECUN) is a common and serious gastrointestinal disease in premature infants.

The diagnosis of ECUN based on clinical and radiological criteria. The abdomen plain film to date is the reference examination to confirm or refute the diagnosis. Indeed, the presence of pathognomonic signs (pneumatosis, aéroportie) on the abdomen of cliché can confirm the diagnosis. The prognostic value of these radiographic findings is currently controversial.

Abdominal ultrasound is a test whose possibilities in diagnostic and prognostic term began to be considered for some years. It also has other advantages, including that of not being a radiating examination. Studies on the prognostic value of abdominal ultrasound are rather few. Moreover, they involve a series of heterogeneous patients in terms of gestational age. Or the pathophysiology of ECUN in children born at term and in children born prematurely is not the same.

The objective is to study prospectively the prognostic contribution of abdominal ultrasound in the ECUN in premature under 33SA.

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
— 至 33 Weeks(Child)
性别
All
接受健康志愿者

入选标准

  • Birth Term strictly less than 33SA
  • Gestational age some (assessed on early ultrasound dating)
  • Congenital malformation of Absence
  • Suggestive clinical symptomatology of ECUN defined by the presence of abdominal bloating, increased residues (> 20% of the volume of enteral feeding) and the presence of blood in stool (macro- or microscopic)
  • Radiologic investigation with a radiograph of abdomen and abdominal ultrasound done for the episode of ECUN
  • Maximum interval between imaging tests 2 hours
  • No parental opposition to the participation of children in the study

排除标准

  • Term higher or equal to 33 weeks
  • Congenital malformation
  • Parental Opposition (or legal representatives) to participate in the study

结局指标

主要结局

Comment prognostic evaluation by abdominal ultrasound

时间窗: 36 months

Assessment in clinical outcome prognosis by abdominal ultrasound

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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