Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia (FETO)
The purpose of this research is to gather information on the safety and effectiveness of a new procedure called Fetoscopic Endoluminal Tracheal Occlusion (FETO).
Conditions:
🦠 Congenital Diaphragmatic Hernia 🦠 Pulmonary Hypoplasia 🦠 Pulmonary Artery Hypertension
🗓️ Study Start (Actual) 1 May 2024
🗓️ Primary Completion (Estimated) 1 December 2024
✅ Study Completion (Estimated) 1 September 2028
👥 Enrollment (Estimated) 10
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Miami, Florida, United States
📍 Rochester, Minnesota, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * Singleton pregnancy
    • * Normal fetal karyotype with confirmation by culture results. Results by fluorescence in situ hybridization (FISH) will be acceptable if the patient is \> 26 weeks.
    • * Isolated Left CDH with liver up
    • * Gestation age at enrollment prior to 29 wks plus 6 days severe pulmonary hypoplasia with ultrasound (US) O/E lung area to head circumference ratio (LHR) \< 25% (measured at 180 to 296 weeks) at the time of surgery; O/E LHR 25% to \<30% (measured at 300 to 316 weeks) at time of surgery.
    • * Gestational age at FETO procedure with O/E LHR \<25% at 27 weeks 0 days to 29 weeks 6 days; with O/E LHR 25% to \<30% at 30 weeks 0 days to 31 weeks 6 days as determined by clinical information (LMP) and evaluation of first ultrasound
    • * Patient meets psychosocial criteria

    Exclusion Criteria:

    • * Multi-fetal pregnancy
    • * History of natural rubber latex allergy
    • * Preterm labor, cervix shortened (\<15 mm at enrollment or within 24 hours of FETO balloon insertion procedure) or uterine anomaly strongly predisposing to preterm labor, placenta previa
    • * Psychosocial ineligibility, precluding consent:
    • * Inability to reside within 30 minute drive of our hospital, and inability to comply with the travel for the follow-up requirements of the trial
    • * Patient does not have a support person (e.g. spouse, partner, mother) available to stay with the patient for the duration of the pregnancy at our institution.
    • * Right sided CDH or bilateral CDH, isolated left sided with O/E LHR ≥30% (measured at 180 to 295 weeks) as determined by ultrasound
    • * Additional fetal anomaly and chromosomal abnormalities by ultrasound, MRI, or echocardiogram at the fetal treatment center. No cases will be removed post hoc if abnormalities are discovered in the course of postoperative monitoring
    • * Maternal contraindication to fetoscopic surgery or severe maternal medical condition in pregnancy
    • * History of incompetent cervix with or without cerclage
    • * Placental abnormalities (previa, abruption, accrete) known at time of enrollment
    • * Maternal-fetal Rh isoimmunization, Kell sensitization or neonatal alloimmune thrombocytopenia affecting the current pregnancy
    • * Maternal HIV, Hepatitis-B, Hepatitis-C status positive because of the increased risk of transmission to the fetus during maternal-fetal surgery. If the patient's HIV or Hepatitis status is unknown, the patient must be tested and found to have negative results before enrollment Uterine anomaly such as large or multiple fibroids or mullerian duct abnormality
    • * Participation in another intervention study that influences maternal and fetal morbidity and mortality or participation in this trial in a previous pregnancy
Ages Eligible for Study: 18 Years to 50 Years (ADULT)
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 1 May 2017
  • First Submitted that Met QC Criteria 1 May 2017
  • First Posted 3 May 2017

Study Record Updates

  • Last Update Submitted that Met QC Criteria 2 May 2024
  • Last Update Posted 3 May 2024
  • Last Verified May 2024