跳至主要内容
临床试验/NCT01441739
NCT01441739Unknown不适用

Intestinal Failure in Necrotising Enterocolitis

Maastricht University Medical Center2 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2004年9月最近更新:
适应症

试验速览

阶段
不适用
入组人数
300
试验地点
2
主要终点
Urinary I-FABP

研究概览

简要总结

Necrotizing enterocolitis (NEC) is a severe gastrointestinal disorder with high morbidity and mortality (20-40%), affecting predominantly premature neonates. NEC continues to present a diagnostic challenge to clinicians. The initial clinical manifestations of NEC are non-specific and indistinguishable from other gastrointestinal disorders and sepsis.

The first goal of this study is to find and evaluate tests to diagnose NEC at an early stage. For the development of new diagnostic markers, the investigators require knowledge of pathophysiological processes that underlie NEC, which still remain unclear. Therefore, the second goal of this study is to elucidate the etiology of NEC. Furthermore, understanding of the pathophysiology of NEC can offer the possibility to develop new therapeutical treatments.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • Neonates with abdominal signs suspected of NEC
  • All neonates admitted to the NICU of the Maastricht University Medical Center between July 2007 and July 2008

排除标准

  • No written informed consent of both parents

结局指标

主要结局

Urinary I-FABP

时间窗: Within the first 30 days (plus or minus 3 days) after clinical suspicion of NEC

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)

Loading locations...

相似试验