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FETO for Severe Congenital Diaphragmatic Hernia

This study is investigating a procedure called Fetal Endotracheal Occlusion (FETO) for babies diagnosed with severe Congenital Diaphragmatic Hernia (CDH) before birth. CDH is a condition where a baby's diaphragm (the muscle that separates the chest and abdomen) doesn't fully form, allowing organs to move into the chest and prevent the lungs from developing properly. In this study, a Goldbal Detachable Balloon is placed in the baby's windpipe between 28 and 31 weeks of pregnancy. The balloon is removed by 36 weeks. The main goal is to see if this procedure helps resolve pulmonary hypertension (high blood pressure in the lungs) by 6 and 12 months of age. Women between 18 and 45 years old with a single pregnancy and a fetus diagnosed with severe CDH can participate. The study aims to enroll 80 participants, but its current status is unclear.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 80 participants, but the phase and whether it's randomized or blinded are not specified.
What's involved
If you join, you would undergo routine evaluations, including ultrasounds and MRI. The FETO procedure involves placing a balloon in the fetus's windpipe and later removing it.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed to see if pulmonary hypertension resolves by 6 months and 12 months after birth.

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NCT03980717

Fetal Endotracheal Occlusion (FETO) in the Resolution of Pulmonary Hypertension in Fetuses With Severe CDH

Recruiting
NAAges 18–45InterventionalTreatment
Michael A Belfort
~80 participants
Updated 2026-02-06 on ClinicalTrials.gov
What's tested:Goldbal Detachable Balloon and delivery microcatheter

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Resolution of Pulmonary Hypertension - 6 months
Measured over by the age of 6 months
+1 more outcome measured

Conditions

Congenital Diaphragmatic Hernia

Explore related trials

Congenital Diaphragmatic Hernia

Where it's being run

1 sites across 1 states
Texas1

Study leadership

  • Michael Belfort, MD PhD · PRINCIPAL_INVESTIGATOR · Baylor College of Medicine

Who to contact

Michael Belfort, MD PhD
[email protected]
832-826-7375
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Patient is a pregnant woman between 18 and 45 years of age
Singleton pregnancy
The fetuses will be 28+0/7 to 31+6/7 weeks of gestational age
Confirmed diagnosis of severe left- or right-sided CDH of the fetus: Observed/expected total lung volume equal to or less than 0.32 with more than 21% of liver herniated into the hemithorax. (Ideally calculated between 28+0/7 and 31+6/7 weeks' gestation.)
Normal fetal echocardiogram or echocardiogram with a minor anomaly (such a small VSD) that in the opinion of the pediatric cardiologist will not affect postnatal outcome
Normal fetal karyotype or microarray
The mother must be healthy enough to have surgery
Patient and father of the baby provide signed informed consent that details the maternal and fetal risks involved with the procedure
Patient willing to remain in Houston for the duration following balloon placement until delivery.

Exclusion

Contraindication to abdominal surgery, fetoscopic surgery, or general anesthesia
Allergy to latex
Allergy or previous adverse reaction to a study medication specified in this protocol
Preterm labor, preeclampsia, or uterine anomaly (e.g., large fibroid tumor) in the index pregnancy.
Fetal aneuploidy, known structural genomic variants, other major fetal anomalies that may impact the fetal/neonatal survival or known syndromic mutation
Suspicion of major recognized syndrome (e.g. Fryns syndrome) on ultrasound or MRI
Maternal BMI \>40
High risk for fetal hemophilia

What this trial measures

  • Resolution of Pulmonary Hypertension - 6 monthsby the age of 6 months

    To compare the proportion of fetuses with resolution of PH by the age of 6 months in neonates with severe CDH who underwent the FETO procedure and that of a control group composed of neonates who did not have the FETO procedure.

  • Resolution of Pulmonary Hypertension - 12 monthsby the age of 12 months

    To compare the proportion of fetuses with resolution of PH by the age of 12 months in neonates with severe CDH who underwent the FETO procedure and that of a control group composed of neonates who did not have the FETO procedure.