The purpose of the study is to determine if babies with left or right-sided CDH that undergo the FETO procedure survive more often and have fewer long-term complications than babies that have similar left or right-sided CDH that elect not to have the FETO procedure performed during pregnancy.
Provision of signed and dated informed consent form
Stated willingness to comply with all study procedures and availability (meets psychosocial criteria below) for the duration of the study
Pregnant women, age 18 years and older
Singleton pregnancy
Patient <18 years of age
Multi-fetal pregnancy
History of natural rubber latex allergy
Preterm labor, short cervix (<20mm within 24 hours of FETO balloon insertion procedure), or uterine anomaly strongly predisposing to preterm labor, placenta previa
Parallel
FETO with Goldballoon Detachable Balloon (GOLDBAL2) along with the Delivery Microcatheter (BALTACCI-BDPE100)
DeviceThis will take place between gestation of 27w0d - 29w6d. The balloon will be removed at approximately 34 weeks gestation.
Compare neonatal survival to discharge in LCDH
Compare neonatal survival to discharge in RCDH
Number of successful placements the of FETO balloon Gestational age of 27 weeks 0 days gestation to 29 weeks 6 days gestation
Number of successful retrievals/puncture of the FETO balloon Gestational age of 33 weeks 0 days to 35 weeks 0 days
Fetal lung growth difference on MRI via o/e Total Fetal Lung Volume (TFLV) (FETO Intervention Arm)
Fetal MRI done prior to balloon placement and again done at approximately 2 weeks of balloon retrieval. Fetal lung growth (difference between 1st and 2nd MRIs will be calculated for FETO intervention arm only).
Fetal lung growth difference based on prenatal ultrasound via o/e LHR (Both Arms)
Prenatal ultrasound (US) will measure the o/e LHR at weekly visits while the balloon is in place (FETO intervention arm) or at routine visits per standard of care (SOC) (expectant arm). Fetal lung growth will be calculated as the difference between the o/e LHR pre- balloon placement (or 29 + 1 week in control) and the o/e LHR immediately prior to balloon removal/puncture (or 34 + 1 week in control).
Long-term outcome measure infant survival rate
Presence of pulmonary hypertension
Determination of the ratio of the tricuspid regurgitation jet (estimation of the right ventricular systolic pressure) to systemic blood pressure where the is an objective measurement used to estimate the pulmonary artery pressure. Will be recorded as absent/none, systemic or suprasystemic.
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Dr Erin Perrone
Lead sponsor
University of Michigan
Sponsor institution
