Trial of Fetoscopic Endoluminal Tracheal Occlusion (FETO) for CDH
Pilot Trial of Fetoscopic Endoluminal Tracheal Occlusion (FETO) in Severe Left Congenital Diaphragmatic Hernia (CDH)
Connecticut Children's Medical Center
15 participants
Sep 1, 2015
INTERVENTIONAL
Conditions
Summary
The rationale for fetal therapy in severe congenital diaphragmatic hernia (CDH) is to restore adequate lung growth for neonatal survival.
Eligibility
Inclusion Criteria7
- 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 Criteria8
- 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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Interventions
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).
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT02530073