Fetal Endoscopic Tracheal Occlusion (FETO) for Severe Congenital Diaphragmatic Hernia

Not Recruiting

Trial ID: NCT05461222


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.

Official Title

A Study of the Effectiveness of Fetal Endoscopic Tracheal Occlusion (FETO) in the Management of Severe Prenatally Diagnosed Congenital Diaphragmatic Hernia (CDH)

Stanford Investigator(s)


Inclusion Criteria:

   - 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

   - 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

Exclusion Criteria:

   - Contraindications to fetal surgery including poorly controlled hypertension, diabetes
   or other maternal medical condition including hematological disorder

   - High risk for preterm labor and/or delivery based on either significant history of
   preterm birth, short cervix (measuring < 20mm), significant uterine anomaly or other
   risk factor, incompetent cervix (requiring cerclage)

   - Non-isolated CDH - CDH with additional structural anomalies

   - Significant maternal obesity defined as a body mass index (BMI) greater than 40. BMI
   is a calculation which includes a person's height and weight

   - History of natural rubber latex allergy

   - Uterine anomaly such as large or multiple fibroids or mullerian duct abnormality

   - Participation in another intervention study that influences maternal and fetal
   morbidity and mortality.

   - Bilateral CDH, left-sided CDH with O/E LHR >25%, or left-sided CDH with O/E LHR <25%
   but liver completely down in abdomen

   - Right-sided CDH O/E LHR >30% or right-sided CDH with O/E LHR <30% with liver
   completely down in abdomen

   - Significant placental abnormalities (abruption, chorioangioma, accreta) known at the
   time of enrollment and/or surgery

   - Maternal-fetal Rhesus isoimmunization, Kell sensitization or neonatal alloimmune
   thrombocytopenia, affecting the current pregnancy.

   - Maternal HIV, Hepatitis B with positive surface antigen, Hepatitis C with presence of
   virus in maternal blood due to risk of fetal transmission during the procedure

   - No safe or feasible fetoscopic approach to balloon placement.


device: Balt "Goldballoon"

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Imee Datoc