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

This study is looking at how well a procedure called Fetal Endoscopic Tracheal Occlusion (FETO) works for babies diagnosed with severe Congenital Diaphragmatic Hernia (CDH). CDH is a condition where a baby's diaphragm, the muscle that separates the chest from the abdomen, doesn't form completely. During FETO, a device called the Balt "Goldballoon" is placed in the baby's windpipe while still in the womb to help their lungs develop. Researchers also want to understand the safety and effectiveness of using this balloon. You may be able to join if you are a pregnant woman between 18 and 50 years old, carrying one baby, and are less than 29 weeks and 6 days pregnant with a severe CDH diagnosis. The main goal is to see how many babies survive until they can go home from the hospital, which will be checked for up to a year after birth. The current status of this study is unclear.

Study design: This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 15 participants.
What's involved: Not specified in the trial record.
Compensation: Not stated in the trial record.
Follow-up: Participants will be followed to see if their baby survives until initial hospital discharge, which is measured at approximately 6 months (up to 1 year).

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

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

Recruiting

NAAges 18–50InterventionalSupportive care

Yair Blumenfeld

~15 participants

Updated 2026-01-29 on ClinicalTrials.gov

What's tested:Balt "Goldballoon"

At a glance

Recruiting sites

1 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Number of neonates who survive until initial hospital discharge

Measured over Average approximately 6 months (up to 1 year)

Conditions

Congenital Diaphragmatic Hernia

Where it's being run

1 sites across 1 states

California1

Study leadership

Yair Blumenfeld, MD · PRINCIPAL_INVESTIGATOR · Stanford University

Who to contact

Kathryn Batham

[email protected]

6507247826

Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime

Eligibility criteria

Inclusion

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

Exclusion

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.

What this trial measures

Number of neonates who survive until initial hospital dischargeAverage approximately 6 months (up to 1 year)

Trialytics