Infant Survival and Long-term Outcome Following Fetoscopic Endoluminal Tracheal Occlusion in Severe Left and Right Congenital Diaphragmatic Hernia, A Phase III Trial
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
• Normal fetal karyotype, Chromosomal Microarray (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.
• Gestational age at enrollment prior to 29w6d
• Fetal CDH with intrathoracic liver herniation with either:
‣ Isolated left CDH with Observed/Expected (o/e) Lung to Head Ratio (LHR) \<30% at enrollment (18w0d-29w5d)
⁃ Isolated right CDH with o/e LHR \<45% at enrollment (18w0d-29w5d)
• Cervical length by transvaginal ultrasound \>20 mm within 24hours of FETO procedure
• Meets psychosocial criteria
‣ Willing to reside within 30 minutes of Von Voigtlander Women's Hospital and ability to maintain follow up appointments
⁃ Patient has a support person (e.g. spouse, partner, friend, parent) that is available to stay with participant for the duration of the pregnancy near Von Voigtlander Women's Hospital
⁃ Willing to comply with restrictions of daily living including inability to exercise, have intercourse, or return to work (work from home approved by Principal Investigator is okay)
• 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
• Normal fetal karyotype, CMA with non-pathologic variants, WES or WGS. Results by fluorescence in situ hybridization (FISH) will be acceptable if the patient is \>26 weeks. (non-intervention arm can have karyotype or microarray prenatally or postnatally)
• Gestational age at enrollment prior to 29w6d
• Fetal CDH with intrathoracic liver herniation with either:
• Isolated left CDH with o/e LHR \<30% at enrollment (18w0d-29w5d)
• Isolated right CDH with o/e LHR \<45% at enrollment (18w0d-29w5d)
• Meets psychosocial criteria
‣ Ability to maintain follow up appointments