"Early" Versus "Standard" Fetal Endoscopic Tracheal Occlusion for Severe Congenital Diaphragmatic Hernia - a Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Infant survival rate
研究概览
简要总结
Congenital diaphragmatic hernia (CDH) is associated high mortality and morbidity, mainly in those cases with severe forms where there are extremely reduced lung volumes, liver herniation and decreased abnormal pulmonary vascularization. Fetal endoscopic tracheal occlusion performed between 26 and 30 weeks (standard FETO) has been shown to increase fetal pulmonary size and vascularity, and to improve infant survival in isolated severe CDH. Fetal pulmonary response followed FETO can be used to predict outcome and is dependent on the size of the fetal lung prior to the procedure.
We hypothesize that performing an earlier FETO, between 22-24 weeks, fetuses with severe form of CDH will have a better fetal pulmonary response and higher chance of surviving.
详细描述
We pretend to investigate if "early FETO" will improve the survival rate and the fetal pulmonary response, by conducting a randomized controlled trial comparing the results with those fetuses that undergo to "standard FETO" (between 26-28 weeks).
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
- 22 Weeks 至 28 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fetuses with isolated congenital diaphragmatic hernia (normal fetal karyotype and absence of any associated structural anomaly);
- •Gestational age established by last menstruation and/or first trimester ultrasonography;
- •Prenatal diagnosis of congenital diaphragmatic hernia before 24 weeks of gestation
- •Severe congenital diaphragmatic hernia (at 24 weeks, lung-to-head ratio <1.0 and at least 1/3 of the liver herniated into the fetal thorax)
- •written informed consent (by the patient)
排除标准
- •Preterm premature rupture of the membranes before randomization
- •Preterm labor before randomization
结局指标
主要结局
Infant survival rate
时间窗: 6 months of life
Percentage of survivors at 6 months of life
次要结局
- Postnatal severe pulmonary arterial hypertension (PAH)(30 days of life)
- Respiratory morbidity(6 months of life)