A Biologic Sample Study for the Validation of Biomarkers of Progressive NEC & Sepsis
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 740
- 试验地点
- 1
- 主要终点
- To verify the diagnostic and prognostic biomarker panels with sufficiently powered new cohorts.
研究概览
简要总结
Necrotizing enterocolitis (NEC) is a severe, sometimes life-threatening inflammation of the intestine that occurs most often in premature babies. If it progresses, the wall of the intestine may perforate, spilling bacteria and stool into the abdomen. Parts or all of the intestine may die. Despite 30 years of clinical studies, the cause of NEC remains unknown.
In this study, we will be conducting an independent case-control validation study to verify the diagnostic and prognostic biomarker panels, develop validated biomarkers on boisensors in preparation for prospective validation studies, and conduct independent prospective validation of biosensor based biomarker panels on clinical samples.
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
- 72 Hours 至 28 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
To verify the diagnostic and prognostic biomarker panels with sufficiently powered new cohorts.
时间窗: 4 years
Study has been amended/extended. Test the NEC diagnostic panel for its ability to distinguish NEC from SIP. Develop validated biomarkers on biosensors in preparation for prospective validation studies. Independent prospective validation of biosensor based biomarker panels.
次要结局
未报告次要终点
研究者
R. Lawrence Moss
Surgeon In Chief
Nationwide Children's Hospital