Randomized Clinical Trial in Order to Assess the Effect of Fetoscopic Tracheal Balloon Occlusion on the Postnatal Disease Course in Neonates With Left Congenital Diaphragmatic Hernia - FDH-ECMO/BALLOON-TRIAL
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 98
- 试验地点
- 2
- 主要终点
- Need for postnatal ECMO therapy
研究概览
简要总结
Left diaphragmatic hernia detected during fetal life carries a high risk for postnatal lung failure due to lung underdevelopment and pulmonary hypertension. In severe cases, extracorporeal membrane oxygenation (ECMO) is used as a life-saving intensive care means to enable survival of severely affected infants.
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 in a less severely affected subgroup of patients is whether by fetoscopic tracheal occlusion, the intensity of postnatal intensive care therapy might be reduced. Primary outcome measure is the need for postnatal ECMO therapy.
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
- 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 left diaphragmatic hernia.
- •Normal karyotype, no further severe anomalies on prenatal ultrasound study.
- •Fetal liver herniation into the chest; gestational age-related lung volume between 20-25% of normal as determined by magnetic resonance imaging between 30+0 - 34+0 weeks+days of gestation.
排除标准
- •Any maternal disease or condition that would result in an increased risk to her health from the experimental procedure.
- •Abnormal fetal karyotype, further severe fetal anomalies on prenatal ultrasound.
结局指标
主要结局
Need for postnatal ECMO therapy
时间窗: First two days of life
次要结局
- Survival to discharge from hospital(Days to discharge)
- Maternal morbidity(Until maternal discharge)
- Fetal / Neonatal morbidity(Overall & at discharge from hospital)
- Premature preterm rupture of membranes(Following the interventions over the remainder of gestation)
- Unintended preterm delivery(Following the interventions before scheduled elective delivery)
- Days in intensive care(Number of day until discharge from ICU)
- Days in hospital(Number of days until discharge from hospital)
- Oxygen dependency on discharge(Days until discharge)