A Study of the Effectiveness of Fetal Endoscopic Tracheal Occlusion (FETO) in the Management of Severe Prenatally Diagnosed Congenital Diaphragmatic Hernia (CDH)
The purpose of the study is to study the efficacy of fetal endoscopic tracheal occlusion (FETO) in cases of severe congenital diaphragmatic hernia (CDH). This study will also collect safety and effectiveness data for the off-label use of the FETO Goldballoon (the balloon that will be inserted into the fetal trachea), manufactured by Balt medical. The investigators hope to study the risks and benefits of FETO in cases of severe CDH in an advanced medical center such as Lucile Packard Children's Hospital (LPCH) Stanford with access to advanced maternal-fetal medicine, neonatal services, and neonatal ECMO, and pediatric surgery.
• Maternal Age: 18-50
• Singleton gestation
• Gestational age before 29 weeks 6 days
• Severe left or right-sided CDH: For severe left sided CDH observed-to-expected lung-to- head ratio (o/e LHR) less than 25% between 22 and 29 6/7 weeks' gestation, liver herniation, MRI lung volumes less than 30% expected based on gestational age nomograms. For severe right sided CDH o/e LHR less than 30 % between 22 and 29 6/7 weeks' gestation, liver herniation, MRI lung volumes less than 30% expected based on gestational age nomograms.
• Normal genetic karyotype or microarray testing by amniocentesis or chorionic villus sampling (CVS)
• Absence of associated fetal structural cardiac anomalies by a dedicated fetal echocardiogram
• Absence of other structural anomalies by ultrasound or MRI
• Appropriate multi-disciplinary counseling performed with maternal-fetal medicine, neonatology, pediatric surgery, genetics, pediatric otolaryngology (ENT).
• Must be willing to remain near LPCH Stanford (within 30 minutes from the hospital) for the duration of the balloon placement.
• No maternal and/or fetal contra-indications to fetal surgery such as a bleeding disorder, poorly controlled diabetes or hypertension, short cervix (measuring \< 20mm), risk for preterm birth etc.
• Planned pregnancy surveillance at LPCH Stanford
• Planned delivery at LPCH Stanford
• Able to provide written consent
• Willingness to comply with all study procedures and availability (meets psychosocial criteria) for the duration of the study including having a support person