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This is a single site pilot trial to study the feasibility of Fetoscopic Endoluminal Tracheal Occlusion (FETO) therapy in the most severe group of fetuses with congenital diaphragmatic hernia (CDH) at Ann & Robert H. Lurie Children's Hospital of Chicago (Lurie Children's). This procedure aims to increase fetal lung volume before birth and improve survival after birth. This study will enroll 10 pregnant women who meet study criteria.
A Goldballoon Detachable Balloon (GOLDBAL2) will be inserted into the fetal trachea and deployed with the Delivery Microcatheter (BALTACCI-BDPE100) between 27 weeks 0 days and 29 weeks and 6 days of gestation. The fetal tracheal balloon will be removed between 34 weeks 0 days and 34 weeks 6 days of gestation or earlier as indicated.
After balloon insertion, participants will be followed weekly and must reside within 30 minutes of Lurie Children's until balloon removal. Additionally, participants will have restrictions from return to work, exercise, or intercourse. The children's health status will be followed until two years of age.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FETO with GOLDBAL2 | Experimental | A detachable balloon will be inserted in the fetal airway during the FETO procedure. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FETO with Goldballoon Detachable Balloon (GOLDBAL2) along with the delivery Microcatheter (BALTACCI-BDPE100) | Device | A Goldballoon Detachable Balloon (GOLDBAL2) will be inserted in the airway of the fetus with severe congenital diaphragmatic hernia (o/e LHR <25% with liver up) during the FETO procedure between gestational age 27 weeks 0 days and 29 weeks and 6 days. The fetal tracheal balloon will be removed at between 34 weeks 0 days and 34 weeks 6 days gestation or earlier as indicated. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of successful placements of Goldballoon Detachable Balloon at gestational age 27 weeks 0 days (27w0d) to 29 weeks 6 days (29w6d) | Successful completion of balloon insertion in fetuses with severe CDH defined as direct visualization of balloon above the carina at the time of FETO procedure. | 27 weeks zero days to 29 weeks 6 days |
| Number of successful removals of balloon | Removal of the balloon will ideally be done at 34th week of gestation or prior to delivery. | Removal prior to delivery, ideally at 34 weeks gestation |
| Measure | Description | Time Frame |
|---|---|---|
| Change in fetal lung growth | Prenatal ultrasound will measure the observed-to-expected lung to head ratio (o/e LHR) at weekly visits while the balloon is in place and after balloon removal. Fetal lung growth will be calculated as the difference between the o/e LHR pre-balloon placement and the o/e LHR after balloon removal. | Baseline (before balloon placement) to first ultrasound after balloon removal |
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Inclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Aimen Shaaban, MD | Contact | 312-227-4747 | AShaaban@luriechildrens.org |
| Name | Affiliation | Role |
|---|---|---|
| Aimen Shaaban, MD | Ann & Robert H Lurie Children's Hospital of Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ann & Robert H. Lurie Children's Hospital of Chicago | Recruiting | Chicago | Illinois | 60611 | United States |
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| Label | URL |
|---|---|
| MedlinePlus Genetics: Congenital diaphragmatic hernia | View source |
| Genetic and rare diseases information resources: Congenital Diaphragmatic Hernia | View source |
| U.S. FDA Resources |
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| ID | Term |
|---|---|
| D065630 | Hernias, Diaphragmatic, Congenital |
| D006548 | Hernia, Diaphragmatic |
| ID | Term |
|---|---|
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D000082122 | Internal Hernia |
| D006547 | Hernia |
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| Gestational age at delivery | Gestational age at delivery will be recorded. | At the time of delivery |
| Infant survival | Infant survival will be measured from delivery to discharge, at 6, 12, and 24 months of age. | Birth to 24 months |
| Number of infants requiring extra corporeal membrane oxygenation (ECMO) support | Use of ECMO will be collected from medical chart review. | Birth to 6 months |
| Number of infants with sepsis | Sepsis occurrences will be collected from medical chart review. | Birth to six months |
| Number of infants with intraventricular hemorrhage (IVH) | Intraventricular hemorrhage data will be collected from medical chart review. | Birth to six months |
| Length of hospital stay | Hospital length of stay will be calculated from medical chart review. | Birth to one year |
| Number of infants requiring supplemental oxygen | Supplemental oxygen requirement at time of discharge will be collected from medical chart review. | Birth to 24 months |
| Number of maternal complications | Complications during pregnancy, delivery, and first post-partum visit to include: preterm labor, premature rupture of membranes (PROM), preterm premature rupture of membranes (PPROM), oligohydramnios, polyhydramnios, placental abruption, chorioamnionitis, and other infection. | Up to 4-6 weeks post-partum |
| View source |
| Hernia | View source |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |