The rationale for fetal therapy in severe congenital diaphragmatic hernia (CDH) is to restore adequate lung growth for neonatal survival.
Pregnant women age 18 years and older, who are able to consent
Singleton pregnancy
Normal Karyotype
Fetal Diagnosis of Isolated Left CDH with liver up
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
Single group
Fetoscopic Endoluminal Tracheal Occlusion (FETO)
DeviceThis 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).
Percent of neonatal survivors at time of discharge
Feasibility, safety, and survival rates of the FETO procedure
Prenatal increase in lung volume
Lung volume after FETO procedure
Number of days of Postnatal mechanical ventilator support
mechanical ventilator support will be monitored and recorded in days of use
Changes in RNA content of tracheal and amniotic fluid
Describe how tracheal occlusion affects the RNA content of amniotic and tracheal fluid in CDH fetuses, and to correlate this transcriptomic profile to the degree of lung hypoplasia and fetal and neonatal clinical outcomes.
Characterization of extracellular vesicles (EVs) and miRNAs in tracheal and amniotic fluid
To describe how extracellular vesicles (EVs) are derived from the amniotic and tracheal fluid of CDH patients before and after tracheal occlusion, and to determine whether the identified miRNAs of interest are intra- or extra-vesicular.
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