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

Sponsored by Michael A Belfort

About this study

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.

Enrollment Women carrying a fetus with severe CDH and a normal karyotype will undergo routine clinical evaluation. The fetus will be 28+0/7 to 31+6/7 weeks of gestational age and have severe CDH. These patients will have ultrasound and/or MRI evaluation to rule out other anomalies, calculation of the LHR from ultrasound measurements, calculation of observed/expected total lung volume and percentage of liver herniation from fetal MRI studies, echocardiography, and detailed obstetric/perinatal consultation. Patients who meet the eligibility criteria will be extensively counseled, and those who wish to participate will provide written, informed consent for the study. Procedure The procedure will be performed under spinal anesthesia or local anesthesia with intravenous sedation. The techniq…

Where this study is enrolling

Who can participate

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

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Trial data sourced from ClinicalTrials.gov.