Recruiting

FETO

Sponsor:

Michael A Belfort

Code:

NCT03980717

Conditions

Congenital Diaphragmatic Hernia

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Not accepted

Interventions

Goldbal Detachable Balloon and delivery microcatheter

Study Details

Brief summary:

Congenital diaphragmatic hernia (CDH) occurs when the diaphragm fails to fully fuse and leaves a portal through which abdominal structures can migrate into the thorax. In the more severe cases, the abdominal structures remain in the thoracic cavity and compromise the development of the lungs. Infants born with this defect have a decreased capacity for gas exchange; mortality rates after birth have been reported between 40-60%. Now that CDH can be accurately diagnosed by mid-gestation, a number of strategies have been developed to repair the hernia and promote lung tissue development.

Fetal tracheal occlusion (FETO), using a fetoscopically delivered and removed balloon device, has been used to temporarily occlude the trachea and increase lung distension in CDH to allow the lungs to develop and has been shown to increase survival at birth. The role of FETO in the resolution of pulmonary hypertension in fetuses with severe left- and right- sided CDH remains unclear. Our recent observation that FETO is associated with a higher proportion of infants who resolve their pulmonary hypertension by the age of 1 year as compared with those who have not had FETO, is based on a retrospective cohort study, which, as with any such design, has some intrinsic limitations. Thus, a prospective cohort study that is appropriately powered to confirm or disprove this encouraging observation is needed. If our preliminary observation is confirmed, resolution of PH by the age of 1 year could be added to the benefits of the FETO procedure in severe left and right-sided CDH cases.

The investigators will perform 40 FETO procedures on fetuses diagnosed prenatally with severe right- or left-sided CDH, and outcome data will be compared with that of a control group of severe right- or left-sided CDH who will not undergo the FETO procedure because of medical or social issues. Because the prevalence of left-sided CDH is higher than right-side CDH, the investigators will perform 25 FETO procedures in left sided CDH and 15 in right-sided CDH, and these outcomes will be compared to a cohort of 40 non FETO cases.

Conditions

Congenital Diaphragmatic Hernia

Study ID

NCT03980717

Start date

Aug 9, 2019

Status verified date

Feb, 2026

Completion date

Dec, 2030

Anticipated

Primary completion date

Dec, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Design

Enrollment

80 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Fetal Endotracheal Occlusion (FETO)

Placement and retrieval of the GoldBAL4 or GoldBAL2 Detachable balloon using the plug/unplug method, using BALTACCIDBPE100 Delivery Catheter.

no intervention: non-FETO

The control group will consist of patients who did not undergo the FETO procedure who fit the same fetal inclusion/exclusion criteria as our FETO subjects and will be matched by variables including maternal age, body mass index, gestational age, severity of CDH and site of CDH (left- or right-sided).

Interventions

Goldbal Detachable Balloon and delivery microcatheter

Between 28+0/7 - 31+6/7 weeks gestation for severe CDH placement of the detachable balloon. Balloon retrieval will be planned for no later than 36+6/7 weeks at the discretion of the FETO center.

Primary outcome measure

  • Resolution of Pulmonary Hypertension - 6 months [ Time Frame: by the age of 6 months ]
  • Resolution of Pulmonary Hypertension - 12 months [ Time Frame: by the age of 12 months ]

Central Contacts and Locations

Central contacts

Michael Belfort, MD PhD

832-826-7375belfort@bcm.edu

Rebecca M Johnson, MS

832-826-7451rj2@bcm.edu

Locations

Texas Childrens Hospital

Recruiting

Houston, Texas, United States, 77030

Contacts

Michael Belfort, M.D.

832-826-7375

Rebecca Johnson, MS

832-826-7451

Principal Investigator:

Michael A Belfort, M.D., PhD

More Information

Sponsor

Michael A Belfort

Last update posted

Feb 6, 2026

Last verified

Feb, 2026

Keywords

  • Fetal Tracheal Occlusion
  • FETO plug-unplug
  • Goldvalve balloon
  • Severe Congenital Diaphragmatic Hernia
  • Goldbal balloon
  • FETO

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Michael A Belfort on 2026-02-06.