This is a single site pilot trial to assess the feasibility and safety of treating severe CDH with Fetal Endoscopic Tracheal Occlusion with the Goldballoon Detachable Balloon (GOLDBAL2) along with the Delivery Microcatheter (BALTACCI-BDPE100) at Michigan Medicine. The study will enroll pregnant women that meet study criteria. Participants will have placement of FETO between gestational age at 27 weeks plus 0 days and 29 weeks 6 days. The timing for removal of FETO will ideally be between 34 weeks 0 days and 34 weeks and 6 days but ultimately decided by the Fetal Diagnosis and Treatment Center at Michigan Medicine. This study requires that study participants live within 30 miles of the Von Voigtlander Women's Hospital and C.S. Mott Children's Hospital in order to maintain weekly follow up appointments while the balloon is in place and up to delivery. Additionally, there are lifestyle considerations where participants would be unable to carry on normal daily activities including exercise and sexual intercourse, not be able to work the remainder of the pregnancy, as well as have a support person that is available to stay with such as a spouse, friend, partner, parent.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
This will take place between gestation of 27w0d - 29w6d. The balloon will be removed at approximately 34 weeks gestation.
University of Michigan
Ann Arbor, Michigan, United States
RECRUITINGNumber of successful placements of the Goldballoon Detachable Balloon (GOLDBAL2) at gestational age 27 weeks zero days (27w0d) to 29 weeks and 6 days (29w6d) gestation.
Success will be defined as completion with direct visual placement above the carina and confirmation on ultrasound done during the procedure.
Time frame: 27w0d - 29w6d
Number of successful retrievals of the GOLDBAL2
This will ideally occur around the 34th week of gestation and have the balloon removed prior to delivery.
Time frame: Removal prior to delivery approximately 34 weeks of gestation
Change in observed to expected total fetal lung to head ratios (o/e TFLV) on prenatal magnetic resonance imaging (MRI)
Fetal MRI done prior to balloon placement and again done at approximately 2 weeks of balloon retrieval.
Time frame: baseline (prior to balloon placement), approximately 2 weeks after balloon retrieval
Change in fetal lung growth
Fetal ultrasounds will be done weekly while the balloon is in place. Fetal lung growth will be calculated as the difference between the o/e LHR pre-balloon placement and the o/e LHR immediately prior to balloon removal.
Time frame: baseline (before balloon placement), immediately prior to balloon retrieval
Gestational age at delivery
Time frame: At the time of delivery (up to approximately 34 weeks)
Survival of infant to hospital discharge or 180 days after hospitalized
This will be measured after the infant is delivered to hospital discharge or analyzed for survival at 180 days for those still hospitalized at that time point.
Time frame: Discharge from hospital or up to 180 days in the hospital
Number of maternal complications
Complications during pregnancy, and/or at delivery and follow-up to include; preterm labor, premature rupture of membranes (PROM), Preterm Premature Rupture of Membranes (PPROM), oligohydramnios, polyhydramnios, placental abruption, chorioamniotic separation, chorioamnionitis, and other infection.
Time frame: up to 4-6 weeks postpartum
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