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.
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.)
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.
Parallel
Goldbal Detachable Balloon and delivery microcatheter
DeviceBetween 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.
Resolution of Pulmonary Hypertension - 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 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.
2-year Survival
To assess two-year neonatal survival following FETO.
Number of participants who undergo a successful completion of surgical procedures/balloon placement
To assess the successful completion of surgical procedures/placement of balloons in fetuses with severe CDH. Case report forms are utilized to record study related data, including any procedural complications such as failed balloon placement or failed balloon retrieval, as well as surgical or anesthesia complications. At least twice a month fetal surveillance will be performed for up to 10 weeks post balloon placement.
Maternal Outcomes- Maternal Morbidity-incidence of preterm delivery
Case report forms are utilized to record study related data through patient's medical chart review. Maternal morbidity will be assessed in terms of incidence of preterm delivery (spontaneous or indicated).
Maternal Outcomes- Maternal Morbidity-incidence of cesarean section
Case report forms are utilized to record study related data through patient's medical chart review. Maternal morbidity will be assessed in terms of incidence of cesarean section rate.
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Michael A Belfort
Lead sponsor
Baylor College of Medicine
Sponsor institution
Baylor College of Medicine
Collaborator
