Despite advances in prenatal diagnosis and postnatal therapies, including ECMO (Extracorporeal Membrane Oxygenation), inhaled nitric oxide therapy, and ventilator strategies that minimize ventilator-induced lung injury, morbidity and mortality rates for babies with severe CDH remain high. The rationale for fetal therapy in severe CDH is to promote adequate lung growth for neonatal survival. Prenatal tracheal occlusion obstructs the normal egress of lung fluid during pulmonary development leading to increased lung tissue stretch, increased cell proliferation, and accelerated lung growth. The investigator's goal with this pilot study is to study the feasibility of implementing Fetoscopic Endoluminal Tracheal Occlusion (FETO) therapy in the most severe group of fetuses with left CDH (LHR O/E \< 25%).
Pregnant women age 18 years and older
Singleton pregnancy
Normal fetal karyotype with confirmation by culture results. Results by fluorescence in situ hybridization (FISH) will be acceptable if the patient is > 26 weeks
Isolated Left CDH with liver up
Failure to meet all inclusion criteria
Patient < 18 years of age
Multi-fetal pregnancy
Rubber latex allergy
Single group
Fetoscopic Endoluminal Tracheal Occlusion Surgery
DeviceFetoscopic Endoluminal Tracheal Occlusion (FETO) surgery will be completed at 27 weeks 0 days - 29 weeks 6 days gestation. Fetoscopic removal of the balloon occlusion will be performed at 34 weeks 0 days to 34 weeks 6 days gestation.
Number of effective placements of balloon to occlude trachea via fetoscopy
Number of effective placements of balloon to occlude trachea via fetoscopy by performing Fetoscopic Endoluminal Tracheal Occlusion (FETO) in fetuses with severe left congenital diaphragmatic hernia (CDH), as defined by lung to head ratio (LHR) Observed/Expected \< 25%
Rate of fetal lung growth after FETO as measured by lung volume.
Fetal lung growth as measured by lung volume.
Rate of fetal lung growth after FETO as measured by Lung to head circumference ratio
Fetal lung growth as measured by Lung to head circumference ratio (LHR) measurements.
Determine survival rate of FETO patients
Survival at 6 months after birth.
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Hanmin Lee
Lead sponsor
University of California, San Francisco
Sponsor institution
