Trial of Fetoscopic Endoluminal Tracheal Occlusion (FETO) for CDH

Connecticut Children's Medical Center15 enrolled

Overview

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%).

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Congenital Diaphragmatic Hernias

Interventions

Fetoscopic Endoluminal Tracheal Occlusion (FETO)DEVICE

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).

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Connecticut Children's Medical Center

Hartford, Connecticut, United States

RECRUITING

Outcomes

Primary Outcomes

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.

Secondary Outcomes

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

Central Contacts

Katie E Boyle, MPH

CONTACT

860-837-6547 Kboyle01@connecticutchildrens.org

Data from ClinicalTrials.gov

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