Feto-Endoscopic Tracheal Occlusion (FETO) for Severe Congenital Diaphragmatic Hernia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change lung growth on prenatal imaging
研究概览
简要总结
Tracheal occlusion IDE approved by FDA for congenital diaphragmatic hernia fetuses.
详细描述
Fetuses with congenital diaphragmatic hernia with liver-up, and an observed to expected lung-to-head ratio of <25%, LHR <1, or a moderate category with o/e LHR <30%, singleton pregnancy, no known other anomalies, gestational age < 29 weeks 6 days (severe), gestational age < 31 weeks 6 days (moderate), no maternal disease, maternal age > 18 years old.... meet criteria to be offered fetal tracheal occlusion. We want to test feasibility and efficacy in our center.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Isolated CDH with liver up
- •Severe pulmonary hypoplasia with ultrasound O/E LHR <25% at the time of surgery
- •Gestational age at FETO procedure 27 weeks 0 days to 29 weeks 6 days
- •Moderate pulmonary hypoplasia with ultrasound O/E LHR <30% and liver-up at the time of surgery
- •Gestational age at FETO procedure 30 weeks 0 days to 31 weeks 6 days in this moderate category
- •Maternal age greater than or equal to 18 years
- •Gestational age at enrollment prior to 29 weeks 6 days, or 31 weeks 6 days in moderate category
- •Normal karyotype or FISH
- •Normal fetal echocardiogram
- •Singleton pregnancy
- •Willing to remain in the greater Cincinnati area for remainder of pregnancy
- •Family considered and decline option of termination of the pregnancy at less than 24 weeks 0 days
- •Family meets psychosocial criteria
排除标准
- •Patient < 18 years old
- •Multi-fetal pregnancy
- •Rubber latex allergy
- •Preterm labor, cervix shortened (<15 mm) or uterine anomaly strongly predisposing to preterm labor, placenta previa
- •Bilateral CDH, isolated left sided CDH with an O/E > 30%
- •Additional fetal anomaly by ultrasound, MRI, or echocardiogram
- •Chromosomal abnormalities
- •Maternal contraindications to fetoscopic surgery or severe maternal condition in pregnancy
- •Incompetent cervix with or without a cerclage
- •Placental abnormalities known at time of enrollment
- •Maternal HIV, Hepatits B, Hepatitis C
- •Maternal uterine anomaly
- •No safe or technically feasible fetoscopic approach to balloon placement
- •Participation in another intervention study that influences maternal and fetal morbidity and mortality or participation in this trial in a previous pregnancy
研究组 & 干预措施
Fetal Tracheal Occlusion
Fetuses with severe or moderate congenital diaphragmatic hernia will be offered fetal tracheal occlusion to increase lung growth.
干预措施: Fetal Tracheal Occlusion (Device)
结局指标
主要结局
Change lung growth on prenatal imaging
时间窗: prenatal period up to 40 weeks gestation
Change in o/eLHR and other prenatal imaging tests
次要结局
- Change need for ECMO therapy(6 months)
- Change neonatal morbidity(1 year)
- Change survival in the severe congenital diaphragmatic hernia subgroup(6 months)
- Change pulmonary hypertension(6 months)