Trial of Fetoscopic Endoluminal Tracheal Occlusion (FETO)

  • STATUS
    Recruiting
  • End date
    Feb 24, 2023
  • participants needed
    15
  • sponsor
    Medical City Children's Hospital
Updated on 24 January 2021
diaphragmatic hernia
pulmonary hypoplasia
fetal therapy

Summary

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

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%).

Details
Condition CONGENITAL ANOMALY NOS, Growth Hormone Deficiencies/Abnormalities, Female Hormonal Deficiencies/Abnormalities, Male Hormonal Deficiencies/Abnormalities, Birth Defects, Growth Hormone Deficiencies/Abnormalities, Female Hormonal Deficiencies/Abnormalities, Male Hormonal Deficiencies/Abnormalities, Congenital Diaphragmatic Hernia, Congenital Diaphragmatic Hernias, Birth Defects
Treatment Fetoscopic Endoluminal Tracheal Occlusion (FETO)
Clinical Study IdentifierNCT02530073
SponsorMedical City Children's Hospital
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

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
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