Pilot Trial FETO for CDH


  • Study type

  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Site IRB
    • Rochester, Minnesota: 16-008720
    NCT ID: NCT03138863
    Sponsor Protocol Number: 16-008720

About this study

Subjects to be enrolled in this study are pregnant women whose unborn baby has been diagnosed with severe congenital diaphragmatic hernia (CDH). CDH is a birth defect occurring early in pregnancy. It is characterized by the development of a hole in the diaphragm, the breathing muscle that separates the chest from the abdomen. As a result, the intestines and other organs in the baby's abdomen can move into the chest and press on the developing lungs. CDH is a serious condition which prevents the fetal lungs from developing normally. The purpose of this study is to gather information on the safety and effectiveness of a new procedure called Fetoscopic Endoluminal Tracheal Occlusion (FETO). FETO involves two surgical procedures while the mother is still pregnant. During the early third trimester of pregnancy, a special tiny balloon is placed in the baby's trachea. After the balloon has been in place for several weeks, the balloon will be removed during a second procedure, generally done when the baby has reached about 34 weeks gestation. The intent of the FETO procedure is to improve development of the lungs in fetuses diagnosed with severe CDH. If better lung development can be promoted, it is expected that overall survival of babies with severe CDH after birth will also be improved.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

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 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 Mayo Clinic, 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 Mayo Clinic.
  • 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 post-operative 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
  • There is no safe or technically feasible fetoscopic approach to balloon placement
  • Participation in another intervention study that influences maternal and fetal morbidity and mortality or participation in this trial in a previous pregnancy

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Rodrigo Ruano, M.D., Ph.D.

Open for enrollment

Contact information:

Maureen Lemens R.N., C.C.R.C.




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