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Recruiting NCT02530073

Trial of Fetoscopic Endoluminal Tracheal Occlusion (FETO) for CDH

No phase Interventional Congenital Diaphragmatic Hernias

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Fetoscopic Endoluminal Tracheal Occlusion (FETO).
Who it may be relevant to
Registry conditions: Congenital Diaphragmatic Hernias. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Detailed 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%).

Interventions

  • 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).

Primary outcome measures

  • Percent of neonatal survivors at time of discharge [Time frame: Discharge from the hospital, an expected average of 12 weeks.]
Secondary outcome measures (4)
  • Prenatal increase in lung volume [Time frame: 2 weeks (prenatally)]
  • Number of days of Postnatal mechanical ventilator support [Time frame: First 28 days of postnatal life]
  • Changes in RNA content of tracheal and amniotic fluid [Time frame: At time of balloon placement and removal]
  • Characterization of extracellular vesicles (EVs) and miRNAs in tracheal and amniotic fluid [Time frame: At time of balloon placement and removal]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Connecticut Children's Medical Center — Hartford

Identifiers

NCT: NCT02530073 · 22-133

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗