Fetoscopic Endoluminal Tracheal Occlusion
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 Midwest Fetal Care Center, a collaboration between Allina Health and Children's Minnesota. This procedure aims to incre
| Condition(s) | Hernia, DIaphragmatic, Congenital |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | 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 Midwest Fetal Care Center, a collaboration between Allina Health and Children's Minnesota. This procedure aims to increase fetal lung volume before birth and improve survival after birth. This study will enroll 10 pregnant people and their baby who meet study criteria. |
| Who can participate | Inclusion Criteria: 1. A subject is defined as a female (18 years or older) who is pregnant. 2. The pregnancy must be a singleton pregnancy. 3. The CDH must be left-sided. 4. The CDH must be severe (Observed to Expected Lung to Head Ratio - O/E LHR - \< 25% from U/S measurements). 5. No associated lethal anomalies (other than the CDH), no pathogenic variants on microarray, and no pathologic findings on karyotype. 6. Fetal echocardiogram with changes expected with CDH and no major structural cardiac defects. 7. Gestational age at time of balloon placement between and including 27 weeks 0 days and 29 weeks 6 days. 8. Cervix length longer than 20 mm at pre-balloon placement evaluation. 9. Acceptance of responsibility to stay locally (within 15 minutes) of MWFCC and Children's Minnesota - Minn |
| Ages | 18 Years |
| Sex | Female |
| Lead sponsor | Children's Hospitals and Clinics of Minnesota |
| Locations | Minneapolis, Minnesota, United States |
| Start date | 2024-02-22 |
| NCT ID | NCT05771688 |
| Official listing | https://clinicaltrials.gov/study/NCT05771688 |