An interventional study of Fetoscopic Endoluminal Tracheal Occlusion (FETO) in Congenital Diaphragmatic Hernias, sponsored by Connecticut Children's Medical Center. Recruiting at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-18.
Sponsored by Connecticut Children's Medical Center · Not applicable, Interventional, and Treatment
The rationale for fetal therapy in severe congenital diaphragmatic hernia (CDH) is to restore adequate lung growth for neonatal survival.
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%).
Fetal
Exclusion Criteria:
An un-blinded non-randomized single arm pilot study of FETO in fetuses with congenital diaphragmatic hernia (CDH)
Device: Fetoscopic Endoluminal Tracheal Occlusion (FETO)
This study will position and remove an endoluminal tracheal balloon in utero (FETO) to study the feasibility of implementing FETO therapy in the most severe group of fetuses with left CDH and observed/expected length head ratio \<25% (O/E LHR).
Also known as: BALT GOLDBAL2 Tracheal Balloon Catheter system
Percent of neonatal survivors at time of discharge
Feasibility, safety, and survival rates of the FETO procedure
Time frame: Discharge from the hospital, an expected average of 12 weeks.
Prenatal increase in lung volume
Lung volume after FETO procedure
Time frame: 2 weeks (prenatally)
Number of days of Postnatal mechanical ventilator support
mechanical ventilator support will be monitored and recorded in days of use
Time frame: First 28 days of postnatal life
Changes in RNA content of tracheal and amniotic fluid
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.
Time frame: At time of balloon placement and removal
Characterization of extracellular vesicles (EVs) and miRNAs in tracheal and amniotic fluid
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.
Time frame: At time of balloon placement and removal
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Hernias, Diaphragmatic, Congenital→
Connecticut Children's Medical Center