This registry study aims to confirm that FETO increases neonatal survival to discharge and reduces long-term morbidity in fetuses with isolated left CDH and o/e LHR \< 30%, or isolated right CDH and o/e LHR ≤ 45%, compared to those receiving standard care. This prospective registry plans to enroll 80 pregnant women (40 treatment/40 control) with fetuses diagnosed with isolated CDH, and the children will be followed for up to 24 months.
Pregnant women age 18 years and older
Singleton pregnancy
Normal Karyotype, chromosomal microanalysis (CMA) with non-pathologic variants, whole exome sequencing (WES) or whole genome sequencing (WGS). Results by fluorescence in situ hybridization (FISH) will be acceptable if the patient is > 26 weeks gestation.
Gestational age at enrollment is prior to 29 weeks + 6 days gestation.
Patient < 18 years of age
Multi-fetal pregnancy
History of natural rubber latex allergy
Preterm labor, cervix shortened (<20 mm at enrollment or within 24 hours of FETO balloon insertion procedure) or uterine anomaly strongly predisposing to preterm labor, placenta previa.
Parallel
Fetal Treatment Arm (FETO Group)
DeviceParticipants will undergo FETO surgery between 27 weeks + 0 days to 29 weeks + 6 days gestation. The FETO intervention involves two procedures: (1) inserting a balloon into the fetal trachea, and (2) removing the balloon before delivery. After the first FETO procedure, participants will be monitored weekly by ultrasound. Removal of the balloon will be performed at 34 weeks + 0 days to 34 weeks + 6 days gestation. Planned delivery will occur after 37 weeks. The follow-up phase will be conducted from birth to 24 months of age.
Number of successful placement of FETO device
Number of successful removal of FETO device
Number of FETO procedure complications
Complications include: Failure FETO insertion procedure, FETO device dislodgement potentially requiring a second FETO insertion, Fetal intraoperative injury, Procedural hemorrhage, Bleeding from insertion site or Abruptions, Post-procedural hemorrhage PPROM, Preterm delivery, Chorioamnion separation, Chorioamnionitis, Polyhydramnios, Oligohydramnios, Emergent removal due to obstetrical complication, Failed percutaneous or fetoscopic removal requiring cesarean section or exit procedure for removal, Neonatal death due to asphyxia if delivery before FETO removal, and Non-reassuring fetal heart rate monitoring.
Number of neonates that survived
Neonatal survival to discharge
Number of infants that survived
Number of infants that survived
Number of infants that survived
Number of infants that survived
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Johns Hopkins University
Lead sponsor
KARL STORZ Endoscopy-America, Inc.
Collaborator
