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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
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.
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States
RECRUITINGNumber 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.
Time frame: 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.
Time frame: Removal prior to delivery, ideally at 34 weeks gestation
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.
Time frame: Baseline (before balloon placement) to first ultrasound after balloon removal
Gestational age at delivery
Gestational age at delivery will be recorded.
Time frame: At the time of delivery
Infant survival
Infant survival will be measured from delivery to discharge, at 6, 12, and 24 months of age.
Time frame: Birth to 24 months
Number of infants requiring extra corporeal membrane oxygenation (ECMO) support
Use of ECMO will be collected from medical chart review.
Time frame: Birth to 6 months
Number of infants with sepsis
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Sepsis occurrences will be collected from medical chart review.
Time frame: Birth to six months
Number of infants with intraventricular hemorrhage (IVH)
Intraventricular hemorrhage data will be collected from medical chart review.
Time frame: Birth to six months
Length of hospital stay
Hospital length of stay will be calculated from medical chart review.
Time frame: Birth to one year
Number of infants requiring supplemental oxygen
Supplemental oxygen requirement at time of discharge will be collected from medical chart review.
Time frame: 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.
Time frame: Up to 4-6 weeks post-partum