Fetoscopic Endoluminal Tracheal Occlusion
Pilot Trial of Fetoscopic Endoluminal Tracheal Occlusion (FETO) in Severe Right and Left Congenital Diaphragmatic Hernia (CDH)
University of Colorado, Denver
10 participants
Nov 16, 2018
INTERVENTIONAL
Conditions
Summary
The purpose of this research study is to see if the FETO surgery and FETO release (surgery to remove the device) works and is safe for babies with severe right or left Congenital Diaphragmatic Hernia (CDH). CDH is a condition in which a hole in the baby's diaphragm allows the abdominal organs to move into the chest and limit lung growth. The goal of the FETO device is to block the airway with a balloon-type device, allowing fluid to build up and help the unborn baby's lungs grow. Bigger lungs may improve the baby's quality of life.
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 or Right CDH with liver up
- Gestation at enrollment prior to 29 wks plus 6 days
- SEVERE pulmonary hypoplasia with Ultra Sound L-sided O/E LHR \< 25% or R-sided O/E LHR \<45%
Exclusion Criteria7
- 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
- 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 (O/E \< 25%; O/E LHR \< 30 %) and right CDH (O/E LHR \< 45%).
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT03674372