NCT01330576终止不适用
Therapeutic Controlled Hypothermia in the Treatment of Neonates With Severe Necrotizing Enterocolitis
Great Ormond Street Hospital for Children NHS Foundation Trust1 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2010年8月2日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Difference in sequential organ failure assessment (SOFA) score
研究概览
简要总结
Hypothesis: Controlled hypothermia to 33.5C for 48 hours reduces the severity of critical illness in neonates with severe necrotizing enterocolitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •weight at diagnosis > 700 grams
- •confirmed NEC (Bell's stage II or III)
- •radiological evidence of pneumatosis coli
- •systemic compromise as defined by increase in ventilation requirement and/or requiring inotopic support
排除标准
- 未提供
研究组 & 干预措施
Standard treatment of care at normothermia
Placebo Comparator
Control group: Standard treatment of care at normothermia
干预措施: Standard treatment of care at normothermia (Procedure)
cooling blanket/mattress
Experimental
Therapeutic controlled hypothermia (33.5C) using cooling blanket/mattress
干预措施: cooling blanket/mattress (Procedure)
结局指标
主要结局
Difference in sequential organ failure assessment (SOFA) score
时间窗: 5 days
Difference in sequential organ failure assessment (SOFA) score at 5 days after intervention
次要结局
- Neurodevelopmental Assessment(24 months)
- Baseline time taken to establish full enteral feeds(5 days)
研究者
研究点 (1)
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