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Observational Study for Fetoscopic Endoluminal Tracheal Occlusion in Severe CDH

This study is looking at babies born with a severe form of Congenital Diaphragmatic Hernia (CDH), a condition where a hole in the diaphragm allows organs to move into the chest. Researchers want to see if a procedure done during pregnancy called Fetoscopic Endoluminal Tracheal Occlusion (FETO) helps these babies survive more often and have fewer long-term problems compared to babies who receive standard care without FETO. You might be able to participate if you are pregnant with a single baby, are between 18 and 50 years old, and your baby has a severe CDH with certain characteristics. The study will follow babies until they are 2 years old to see how many FETO procedure complications occur and how many babies survive to leave the hospital. The current status of this study is unclear.

Study design
This is an observational study, meaning researchers will follow participants who either choose to have the FETO procedure or receive standard care. The study plans to enroll 80 participants.
What's involved
Mothers who choose to undergo the FETO procedure or receive expectant management will be followed until their infant is 2 years of age.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed until the infant is 2 years of age.

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NCT07564297

North American Fetal Therapy Network Prospective Registry for Long-term Outcome Following Fetoscopic Endoluminal Tracheal Occlusion in Severe Left and Right Congenital Diaphragmatic Hernia

Enrolling by Invitation
Not specifiedAges 18–50Observational
Mayo Clinic
~80 participants
Updated 2026-08-18 on ClinicalTrials.gov
What's tested:Fetoscopic Endoluminal Tracheal OcclusionStandard of Care

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of FETO procedure complications
Measured over 2 years
+1 more outcome measured

Conditions

Congenital Diaphragmatic Hernia

Explore related trials

Congenital Diaphragmatic Hernia

Where it's being run

1 sites across 1 states
Minnesota1

Study leadership

  • Mauro Schenone, MD · PRINCIPAL_INVESTIGATOR · Mayo Clinic

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Singleton pregnancy
Normal fetal karyotype with confirmation by culture results, CMA with non-pathological variants, WES or WGS. Results by fluorescence in situ hybridization (FISH) will be acceptable if the patient is \> 26 weeks
Gestational age at enrollment prior to 29 6/7 weeks
Intrathoracic liver herniation Isolated left CDH with O/E LHR \< 30% at enrollment (18 0/7 to 29 5/7 weeks.) Isolated right CDH with O/E LHR \< 45% at enrollment (18 0/7 to 29 5/7 weeks).
Cervical length by transvaginal ultrasound \> 20 mm within 24 to 48 hours prior to FETO procedure
Patient meets psychosocial criteria
Informed consent understood

Exclusion

Multi-fetal pregnancy
History of natural rubber latex allergy
Preterm labor, cervix shortened (\<20 mm at enrollment or within 24 to 48 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 minutes 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.
Bilateral CDH, isolated left sided CDH with O/E LHR 30% (measured at 180 to 295 weeks), isolated right sided CDH with O/E LHR \> 45% (measured at 180 to 295 weeks), as determined by ultrasound.
No intrathoracic liver herniation
Additional fetal anomaly and chromosomal abnormalities, associated anomalies recognized to alter survival prognosis (i.e., congenital heart disease) or presence of an underlying genetic syndrome (i.e., Fryns) by ultrasound, MRI, or echocardiogram at the fetal treatment center.
Maternal contraindication to fetoscopic surgery or severe maternal medical condition in pregnancy
History of incompetent cervix with or without cerclage
Placental abnormalities (previa, abruption, accreta) 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

What this trial measures

  • Number of FETO procedure complications2 years

    FETO procedure complications are defined as device dislodgement, intraoperative injury to fetus, procedural hemorrhage, post-procedural hemorrhage, preterm delivery, chorioamnion separation, chorioamnionitis, polyhydramnios, oligohydramnios, failed percutaneous or fetoscopic removal requiring cesarean section or EXIT procedure for removal, neonatal death due to asphyxia (if delivery before FETO removal), non-reassuring fetal heart rate monitoring.

  • Neonatal survival to discharge2 years

    Number of neonates to survive from delivery to hospital discharge