North American Fetal Therapy Network Prospective Registry for Long-term Outcome Following Fetoscopic Endoluminal Tracheal Occlusion in Severe Left and Right Congenital Diaphragmatic Hernia
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.
• Intrathoracic liver herniation:
‣ Isolated left CDH with o/e LHR \< 30% at enrollment (18wks + 0 days to 29wks + 5 days gestation).
⁃ Isolated right CDH with o/e LHR ≤ 45% at enrollment (18wks + 0 days to 29wks + 5 days gestation).
• Cervical length by transvaginal ultrasound ≥ 20 mm within 24 hours prior to FETO procedure.
• Patient meets psychosocial criteria.
• Informed consent understood.