NCT01833000Unknown不适用
Assessment of Splanchnic Oxygenation and Circulation in Neonates at Risk for Necrotizing Enterocolitis Using NIRS and Doppler
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 69
- 试验地点
- 2
- 主要终点
- Cerebro-splanchnic oxygenation ratio
研究概览
简要总结
The main objective is to evaluate the interest of cerebro-splanchnic oxygenation ratio (CSOR) for early diagnosis of necrotizing enterocolitis (NEC) in neonates with rectal bleeding and/or abdominal distension. CSOR will be determined using near infrared spectroscopy (NIRS).
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 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •less than 28 days neonates hospitalised in neonatology care unit presenting rectal bledding and/or abdominal distension
- •signed authorization by the parents (consent form)
排除标准
- •- cutaneous lesions in the regions of monitoring
- •emergency for NEC
结局指标
主要结局
Cerebro-splanchnic oxygenation ratio
时间窗: up to 48h
NIRS assessment
次要结局
- Mesenteric Doppler flow(up to 48h)
研究者
研究点 (2)
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