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The purpose of this research is to gather information on the safety and effectiveness of a procedure called Fetoscopic Endoluminal Tracheal Occlusion (FETO) at Mayo Clinic. The intent of the FETO procedure is to improve development of the lungs in fetuses diagnosed with severe congenital diaphragmatic hernia (CDH).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FETO Group | Experimental | Participants will undergo fetal endoscopic tracheal occlusion (FETO) surgical procedure between 27 weeks 0 days and 29 weeks 6 days gestation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BALT GOLDBALL 2 detachable latex ballon | Device | Inflated with fluid in the fetal trachea and provide with the occlusion necessary to promote lung growth. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Technical success of the balloon placement procedure | The number of successful balloon placement procedures defined as balloon was correctly inflated and placed/secured in the trachea. | Up to 29 weeks gestation |
| Technical success of balloon retrieval procedure | The number of successful balloon retrieval procedure defined as antenatal removal of the balloon. | Up to 34 weeks gestation |
| Operative times | FETO placement and release operative times reported in minutes | Up to 34 weeks gestation |
| Frequency of unplanned balloon removal | The frequency of non-emergent and emergent completion of FETO release (unplanned balloon removal) | Up to 34 weeks gestation |
| Number of incidences of maternal complications | Maternal complications including preterm labor, premature rupture of membranes, oligohydramnios, polyhydramnios, chorioamnionitis | Up to 41 weeks gestation |
| Gestational Age at Delivery | Gestation Age reported at time of delivery | Up to 41 weeks gestation |
| Measure | Description | Time Frame |
|---|---|---|
| Fetal Lung Growth as measured via Fetal Lung Volume | Fetal Lung Volume as measured via ultrasound | Up to 24 months post partum |
| Fetal Lung Growth as measured via LHR | Lung area to head circumference Ratio (LHR) as measured via ultrasound |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mauro Schenone, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Minnesota | Recruiting | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Term |
|---|---|
| D065630 | Hernias, Diaphragmatic, Congenital |
| ID | Term |
|---|---|
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006548 | Hernia, Diaphragmatic |
| D000082122 | Internal Hernia |
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| ID | Term |
|---|---|
| D020669 | Fetoscopes |
| ID | Term |
|---|---|
| D019723 | Endoscopes |
| D019719 | Diagnostic Equipment |
| D004864 | Equipment and Supplies |
| D013523 | Surgical Equipment |
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| BALTACCIBDPE100 Microcatheter | Device | Used to deliver the detachable balloon |
|
| Storz fetoscopic operating sheath and miniature telescope/fetoscope | Device | Used to percutaneously enter though the maternal abdominal wall, uterus and into the amniotic cavity, fetal mouth, pharynx, larynx, into the trachea where the delivery catheter will be used to deliver the detachable balloon that will provide with the tracheal occlusion. |
|
| Up to 24 months post partum |
| Fetal Survival | Survival at 30 days, discharge from the hospital and at 6 months if still hospitalized | Up to 6 months post partum |
| Fetal Oxygen Dependency | Oxygen dependency graded as none, mild, moderate, severe as assessed by treating physician | Up to 24 months post partum |
| Occurrence of severe pulmonary hypertension | Number of occurrence of severe pulmonary hypertension in infants based on echocardiogram | Up to 24 months post partum |
| ECMO Support | Number of infants reported that required Extracorporeal membrane oxygenation (ECMO) support | Up to 24 months post partum |
| Number of days in NICU | Number of days infant was in neonatal intensive care unit | Up to 24 months post partum |
| Number of days of ventilator support | Number of reported days infants required ventilator support | Up to 24 months post partum |
| Number of periventricular leukomalacia at < 2 months postnatally | Number of infants reported presence of periventricular leukomalacia at < 2 months postnatally | Up to 2 months post partum |
| Number of infant complications | Number of infants reporting the presence of: neonatal sepsis, intraventricular hemorrhage (grade 3 or higher), retinopathy of prematurity (grade 3 or higher) or gastro-esophageal reflux | Up to 24 months post partum |
| Use of patch or muscle flap | Number of infants reported to require the use of patch or muscle flap | Up to 24 months post partum |
| Maternal hospitalization | Number of reported days of maternal hospitalization | Up to 24 months post partum |
| Route of delivery | Number of participants that delivered vaginally and via caesarean section | Day 1 (post partum) |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |