Actively Recruiting
Fetal Endotracheal Occlusion (FETO) in the Resolution of Pulmonary Hypertension in Fetuses With Severe CDH
Led by Michael A Belfort · Updated on 2026-02-06
80
Participants Needed
1
Research Sites
590 weeks
Total Duration
On this page
Sponsors
M
Michael A Belfort
Lead Sponsor
B
Baylor College of Medicine
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Fetal Endotracheal Occlusion (FETO) in the Resolution of Pulmonary Hypertension in Fetuses With Severe CDH
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pregnant women aged 18 to 45 years
- Singleton pregnancy
- Fetus between 28+0/7 and 31+6/7 weeks gestation
- Severe left- or right-sided CDH with observed/expected total lung volume ≤ 0.32 and >21% liver herniation
- Normal fetal echocardiogram or minor anomaly not expected to affect outcome
- Normal fetal karyotype or microarray
- Mother healthy enough for surgery
- Signed informed consent from patient and baby's father
- Willingness to remain near the hospital until delivery after balloon placement
You will not qualify if you...
- Contraindications to abdominal or fetoscopic surgery or general anesthesia
- Allergy to latex
- Allergy or adverse reaction to study medications
- Preterm labor, preeclampsia, or uterine anomalies during pregnancy
- Fetal aneuploidy, major fetal anomalies, or syndromic mutations affecting survival
- Suspicion of major recognized syndromes (e.g., Fryns syndrome) on imaging
- Maternal BMI greater than 40
- High risk for fetal hemophilia
AI-Screening
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Trial Site Locations
Total: 1 location
1
Texas Childrens Hospital
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
M
Michael Belfort, MD PhD
CONTACT
R
Rebecca M Johnson, MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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