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%).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Fetoscopic 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.
University of California San Francisco Fetal Treatment Center
San Francisco, California, United States
RECRUITINGNumber 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%
Time frame: Between 27 and 29 weeks gestation
Rate of fetal lung growth after FETO as measured by lung volume.
Fetal lung growth as measured by lung volume.
Time frame: Between 27 and 34 weeks gestation
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.
Time frame: Between 27 and 34 weeks gestation
Determine survival rate of FETO patients
Survival at 6 months after birth.
Time frame: 6 months after birth
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