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NCT Number: NCT02530073

Trial of Fetoscopic Endoluminal Tracheal Occlusion (FETO) for CDH

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

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Key information

Conditions

Congenital Diaphragmatic Hernias Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Hernia Hernia, Diaphragmatic Hernias, Diaphragmatic, Congenital Internal Hernia Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Connecticut Children's Medical Center

Hartford, Connecticut, 06106, United States

Location status: Recruiting

Location contact

Katie E Boyle, MPH

CONTACT

[email protected]

860-837-6547

About this study

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%).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Other names: BALT GOLDBAL2 Tracheal Balloon Catheter system

Primary outcomes

  1. Percent of neonatal survivors at time of discharge

    Time frame: Discharge from the hospital, an expected average of 12 weeks.

    Feasibility, safety, and survival rates of the FETO procedure

Secondary outcomes

  1. Prenatal increase in lung volume

    Time frame: 2 weeks (prenatally)

    Lung volume after FETO procedure

  2. Number of days of Postnatal mechanical ventilator support

    Time frame: First 28 days of postnatal life

    mechanical ventilator support will be monitored and recorded in days of use

  3. Changes in RNA content of tracheal and amniotic fluid

    Time frame: 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.

  4. Characterization of extracellular vesicles (EVs) and miRNAs in tracheal and amniotic fluid

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Katie E Boyle, MPH

CONTACT

[email protected]

860-837-6547

Sponsors and collaborators

Lead sponsor

Connecticut Children's Medical Center

Other

Registry information

Official study title

Pilot Trial of Fetoscopic Endoluminal Tracheal Occlusion (FETO) in Severe Left Congenital Diaphragmatic Hernia (CDH)

Acronym: FETO

Important dates

Study start
2015
Primary completion
2028
Study completion
2030
First posted
Aug 20, 2015
Registry last updated
Jun 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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