NCT00373763撤回不适用
Randomized Clinical Trial for the Assessment of the Life-Saving Potential of Fetoscopic Tracheal Balloon Occlusion in Fetuses With Severe Congenital Diaphragmatic Hernia - EUROTRIAL I
University Hospital, Bonn4 个研究点 分布在 1 个国家目标入组 98 人开始时间: 2007年1月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 98
- 试验地点
- 4
- 主要终点
- Survival to discharge from hospital
研究概览
简要总结
Diaphragmatic hernia detected in fetal life carries a high risk for postnatal demise due to lung underdevelopment. Clinical experience from prospective controlled non-randomized case series with fetoscopic tracheal balloon occlusion has seen improved survival rates in contrast to untreated controls. Therefore, the purpose of this randomized clinical trial is to provide further evidence about the efficacy and safety of the prenatal interventional approach. Primary outcome measure is postnatal survival to discharge from hospital treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant women from European countries carrying fetuses with congenital right or left diaphragmatic hernias
- •Normal karyotype, no further severe anomalies on prenatal ultrasound study
- •Fetal liver herniation into the chest, Lung-to-head ratio of ≥0,40 ≤0,84 between 30+0 - 33+5 weeks+days of gestation
排除标准
- •Any maternal disease or condition that would result in an increased risk to her personal health from the experimental procedure
- •Abnormal fetal karyotype
- •Further severe fetal anomalies on prenatal ultrasound
结局指标
主要结局
Survival to discharge from hospital
次要结局
- Maternal morbidity
- Fetal morbidity
- Premature preterm rupture of membranes
- Unintended preterm delivery
- Conventional ventilation strategies possible
- ECMO required
- Days in intensive care
- Days in hospital
- Oxygen dependency on discharge
研究者
研究点 (4)
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