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

RecruitingNAAges 18 Years - 45 YearsFemaleMichael A Belfort
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In plain words

What the trial is, and whether it could suit you

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 h

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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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What it tests

  • Goldbal Detachable Balloon and delivery microcatheter
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Where

1 site
Texas Childrens Hospital
Houston, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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