Trial of Fetoscopic Endoluminal Tracheal Occlusion (FETO) for CDH
- Conditions
- Congenital Diaphragmatic Hernias
- Interventions
- Device: Fetoscopic Endoluminal Tracheal Occlusion (FETO)
- Registration Number
- NCT02530073
- Lead Sponsor
- Connecticut Children's Medical Center
- Brief Summary
The rationale for fetal therapy in severe congenital diaphragmatic hernia (CDH) is to restore adequate lung growth for neonatal survival.
- Detailed Description
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%).
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 15
- Pregnant women age 18 years and older, who are able to consent
- Singleton pregnancy
Fetal
- 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%
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Fetoscopic Endoluminal Tracheal Occlusion (FETO) Fetoscopic Endoluminal Tracheal Occlusion (FETO) An un-blinded non-randomized single arm pilot study of FETO in fetuses with congenital diaphragmatic hernia (CDH)
- Primary Outcome Measures
Name Time Method Percent of neonatal survivors at time of discharge Discharge from the hospital, an expected average of 12 weeks. Feasibility, safety, and survival rates of the FETO procedure
- Secondary Outcome Measures
Name Time Method Prenatal increase in lung volume 2 weeks (prenatally) Lung volume after FETO procedure
Number of days of Postnatal mechanical ventilator support First 28 days of postnatal life mechanical ventilator support will be monitored and recorded in days of use
Changes in RNA content of tracheal and amniotic fluid At time of balloon placement and removal Describe how tracheal occlusion affects the RNA content of amniotic and tracheal fluid in CDH fetuses, and to correlate this transcriptomic profile to the degree of lung hypoplasia and fetal and neonatal clinical outcomes.
Characterization of extracellular vesicles (EVs) and miRNAs in tracheal and amniotic fluid At time of balloon placement and removal To describe how extracellular vesicles (EVs) are derived from the amniotic and tracheal fluid of CDH patients before and after tracheal occlusion, and to determine whether the identified miRNAs of interest are intra- or extra-vesicular.
Trial Locations
- Locations (1)
Connecticut Children's Medical Center
🇺🇸Hartford, Connecticut, United States