Trial of Fetoscopic Endoluminal Tracheal Occlusion (FETO) for CDH

Last updated: May 13, 2025
Sponsor: Connecticut Children's Medical Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hernia

Treatment

Fetoscopic Endoluminal Tracheal Occlusion (FETO)

Clinical Study ID

NCT02530073
22-133
  • Ages > 18
  • Female

Study Summary

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

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Pregnant women <18 years of age.

  • Maternal contraindication to fetoscopic surgery or severe maternal medical conditionin pregnancy

  • Technical limitations precluding fetoscopic surgery

  • Rubber latex allergy

  • Preterm labor, cervix shortened (<15 mm at enrollment or within 24 hours of FETOballoon insertion procedure) or uterine anomaly strongly predisposing to pretermlabor, placenta previa

  • Psychosocial ineligibility, precluding consent

  • Diaphragmatic hernia: right-sided or bilateral, major associated anomalies, isolatedleft-sided with the O/E LHR ≥ 25%

  • Inability to remain at FETO site during time period of tracheal occlusion, deliveryand postnatal care

Study Design

Total Participants: 15
Treatment Group(s): 1
Primary Treatment: Fetoscopic Endoluminal Tracheal Occlusion (FETO)
Phase:
Study Start date:
September 01, 2015
Estimated Completion Date:
August 31, 2030

Study 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%).

Connect with a study center

  • Childrens Hospital Colorado

    Aurora, Colorado 80045
    United States

    Site Not Available

  • Connecticut Children's Medical Center

    Hartford, Connecticut 06106
    United States

    Active - Recruiting

  • Medical City Children's Hospital

    Dallas, Texas 75230
    United States

    Site Not Available

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