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临床试验/ISRCTN14384676
ISRCTN14384676已完成不适用

Early Diagnosis of Necrotising EnteroColitis: a prospective observational multicentre trial in neonates presenting with acute abdome

Island Hospital (Inselspital) (Switzerland)0 个研究点目标入组 50 人开始时间: 2007年7月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
50

研究概览

简要总结

暂无简介。

研究设计

研究类型
Observational

入排标准

性别
All

入选标准

  • Current information as of 11/05/2009:
  • 1. Newborns below 36 days of postnatal age
  • 2. Acute abdomen with suspicion of NEC
  • 3. Gestational age below 34 weeks of gestational age (GA)
  • 4. Written parental consent
  • Initial information at time of registration:
  • 1. Newborns below 36 days of postnatal age
  • 2. Clinical, laboratory and radiological assessment for an acute abdomen possibly due to NEC
  • 3. For the diagnosis of NEC among infants presenting with an acute abdomen, the criteria of Bell, modified by Walsh and Kliegman and adopted by the Vermont Oxford Network:
  • 3.1. The presence of one or more of the following clinical signs:
  • 3.1.1. Feeding intolerance with bilious gastric aspirate or emesis
  • 3.1.2. Abdominal distension
  • 3.1.3. Occult or gross blood in stool (no fissure)
  • 3.2. And one or more of the three following radiographic findings:
  • 3.2.1. Pneumatosis intestinalis
  • 3.2.2. Hepato-biliary gas
  • 3.2.3. Pneumoperitoneum

排除标准

  • Current information as of 11/05/2009:
  • 1. Age above 35 days of postnatal age
  • 2. Patients that had undergone surgery one week prior to onset of the disease
  • Initial information at time of registration:
  • 1. Age above 35 days of postnatal age
  • 2. Patients that had undergone surgery one week prior to onset of the disease
  • 3. Focal intestinal perforation consistent with:
  • 3.1. Visual aspect of the bowel at the time of surgery and post-mortem
  • 3.2. Absence of inflammation and coagulative necrosis in histological findings

研究者

发起方
Island Hospital (Inselspital) (Switzerland)

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