Fetal Endotracheal Occlusion (FETO) in the Resolution of Pulmonary Hypertension in Fetuses With Severe CDH
Congenital Diaphragmatic Hernia
About this trial
This is an interventional treatment trial for Congenital Diaphragmatic Hernia focused on measuring Fetal Tracheal Occlusion, FETO plug-unplug, Goldvalve balloon, Severe Congenital Diaphragmatic Hernia, Goldbal balloon, FETO
Eligibility Criteria
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
Sites / Locations
- Texas Childrens HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Fetal Endotracheal Occlusion (FETO)
non-FETO
Placement and retrieval of the GoldBAL4 or GoldBAL2 Detachable balloon using the plug/unplug method, using BALTACCIDBPE100 Delivery Catheter.
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).