Intestinal Failure in Necrotising Enterocolitis
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
- 否
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
