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

Part of paid clinical trials in Houston, Texas.

Sponsor
Michael A Belfort
Study ID
NCT03980717
Status
Recruiting
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Conditions

  • Congenital Diaphragmatic Hernia

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 45 Years
Healthy Volunteers
Not accepted

Interventions

  • Goldbal Detachable Balloon and delivery microcatheter — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Aug 9, 2019
Status verified
Feb 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2030

Study Design

Enrollment
80 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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).

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Texas Childrens HospitalHoustonTexas77030
Michael Belfort, M.D.
832-826-7375
Rebecca Johnson, MS
832-826-7451
Michael A Belfort, M.D., PhD (PRINCIPAL_INVESTIGATOR)
Timothy Lee, M.D. (SUB_INVESTIGATOR)
Magdalena Sanz Cortes, M.D., PhD (SUB_INVESTIGATOR)
Ahmed Nassr, M.D., PhD (SUB_INVESTIGATOR)
Wesley Lee, M.D. (SUB_INVESTIGATOR)
Alice King, M.D. (SUB_INVESTIGATOR)
Roopali Donepudi, M.D. (SUB_INVESTIGATOR)
Sundeep Keswani, M.D. (SUB_INVESTIGATOR)
Caitlin Sutton, M.D. (SUB_INVESTIGATOR)
Betul Yilmaz, M.D. (SUB_INVESTIGATOR)
Ryan Coleman, M.D. (SUB_INVESTIGATOR)
Luc Joyeux, M.D., PhD (SUB_INVESTIGATOR)

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By research site
Texas Childrens Hospital· Houston, TX

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