Pilot Trial of Fetoscopic Endoluminal Tracheal Occlusion (FETO) in Severe Left Congenital Diaphragmatic Hernia (CDH)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Percent of neonatal survivors at time of discharge
研究概览
简要总结
The rationale for fetal therapy in severe congenital diaphragmatic hernia (CDH) is to restore adequate lung growth for neonatal survival.
详细描述
Prenatal tracheal occlusion (TO) obstructs the normal egress of lung fluid during pulmonary development leading to increased lung tissue stretch, increased cell proliferation, and accelerated lung growth. European colleagues have developed foregut endoscopy and techniques to position and remove endoluminal tracheal balloons in utero. Recently, the Belgium group published summary results of FETO showing an improved survival in 175 patients with isolated left CDH from 24% to 49%.
The goal of this pilot study is to study the feasibility of implementing FETO therapy in the most severe group of fetuses with left CDH Observed/expected lung-to-head ratio < 25%(O/E LHR < 25%).
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant women age 18 years and older, who are able to consent
- •Singleton pregnancy
- •Normal Karyotype
- •Fetal Diagnosis of Isolated Left CDH with liver up
- •Gestation at enrollment prior to 29 wks plus 6 days
- •SEVERE pulmonary hypoplasia with Ultra Sound O/E LHR < 25%
排除标准
- •Pregnant women <18 years of age.
- •Maternal contraindication to fetoscopic surgery or severe maternal medical condition in pregnancy
- •Technical limitations precluding fetoscopic surgery
- •Rubber latex allergy
- •Preterm labor, cervix shortened (<15 mm at enrollment or within 24 hours of FETO balloon insertion procedure) or uterine anomaly strongly predisposing to preterm labor, placenta previa
- •Psychosocial ineligibility, precluding consent
- •Diaphragmatic hernia: right-sided or bilateral, major associated anomalies, isolated left-sided with the O/E LHR ≥ 25%
- •Inability to remain at FETO site during time period of tracheal occlusion, delivery and postnatal care
研究组 & 干预措施
Fetoscopic Endoluminal Tracheal Occlusion (FETO)
An un-blinded non-randomized single arm pilot study of FETO in fetuses with congenital diaphragmatic hernia (CDH)
干预措施: Fetoscopic Endoluminal Tracheal Occlusion (FETO) (Device)
结局指标
主要结局
Percent of neonatal survivors at time of discharge
时间窗: Discharge from the hospital, an expected average of 12 weeks.
Feasibility, safety, and survival rates of the FETO procedure
次要结局
- Prenatal increase in lung volume(2 weeks (prenatally))
- Number of days of Postnatal mechanical ventilator support(First 28 days of postnatal life)
- Changes in RNA content of tracheal and amniotic fluid(At time of balloon placement and removal)
- Characterization of extracellular vesicles (EVs) and miRNAs in tracheal and amniotic fluid(At time of balloon placement and removal)
研究者
Timothy Crombleholme
Director of Fetal Care Center
Connecticut Children's Medical Center