Trial of Fetoscopic Endoluminal Tracheal Occlusion (FETO) for CDH

Connecticut Children's Medical Center

Status: Enrolling

Conditions: Congenital Diaphragmatic Hernias

Treatments: Device: Fetoscopic Endoluminal Tracheal Occlusion (FETO)

Study type: Interventional

Funder types: Other

Identifiers

NCT02530073

22-133

Details and patient eligibility

About

The rationale for fetal therapy in severe congenital diaphragmatic hernia (CDH) is to restore adequate lung growth for neonatal survival.

Full 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%).

Enrollment: 15 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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%

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Fetoscopic Endoluminal Tracheal Occlusion (FETO)

Experimental group

Description:

An un-blinded non-randomized single arm pilot study of FETO in fetuses with congenital diaphragmatic hernia (CDH)

Treatment:

Device: Fetoscopic Endoluminal Tracheal Occlusion (FETO)