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FETO for Severe Congenital Diaphragmatic Hernia

This study is looking at a fetal surgery called Fetoscopic Endoluminal Tracheal Occlusion (FETO) for babies diagnosed with severe congenital diaphragmatic hernia (CDH). CDH is a birth defect where a hole in the diaphragm (the muscle that separates the chest and abdomen) allows organs to move into the chest, which can prevent the lungs from developing properly. The FETO procedure involves placing a balloon in the baby's windpipe (trachea) while still in the womb to help the lungs grow. Researchers want to see how well the FETO device can be placed and removed, and if it helps babies survive until they can go home from the hospital. They are comparing babies who receive FETO to those who receive standard care. This study is for pregnant women carrying a single baby with severe CDH, who are able to consent and meet specific genetic criteria. The study aims to enroll 80 participants.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It aims to enroll 80 participants.
What's involved
If you participate, you would undergo FETO surgery between 27 weeks 0 days and 29 weeks 6 days of pregnancy. This would be followed by weekly ultrasound monitoring and an MRI three weeks after the balloon is inserted and removed.
Compensation
Not stated in the trial record.
Follow-up
The study will track the number of babies who survive from delivery until they are discharged from the hospital, up to 12 months.

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NCT06739356

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

Recruiting
NAAges 18+InterventionalTreatment
The University of Texas Health Science Center, Houston
~80 participants
Updated 2025-08-19 on ClinicalTrials.gov
What's tested:Fetal Treatment arm (FETO Group)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of neonates that survived
Measured over from delivery to hospital discharge (up to 12 months)
+3 more outcomes measured

Conditions

Congenital Diaphragmatic Hernia

Explore related trials

Congenital Diaphragmatic Hernia

Where it's being run

1 sites across 1 states
Texas1

Study leadership

  • Anthony Johnson, DO · PRINCIPAL_INVESTIGATOR · The University of Texas Health Science Center, Houston

Who to contact

Anthony Johnson, DO
[email protected]
(713) 500-5859
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Pregnant women who are able to consent
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
Gestational age at enrollment is prior to 296 wks.
Intrathoracic liver herniation
Isolated left CDH with o/e LHR \< 30% at enrollment (180 to 295 wks.). or
Isolated RCDH with o/e LHR \< 45% at enrollment (180 to 295 wks.)
Cervical length by transvaginal ultrasound \> 20 mm within 24 hours prior to FETO procedure
Patient meets psychosocial criteria
Informed consent understood

Exclusion

History of natural rubber latex allergy
Preterm labor, cervix shortened (\<20 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:
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 liver herniation into thoracic cavity
Additional fetal anomaly and chromosomal abnormalities by ultrasound, MRI, or echocardiogram at the fetal treatment center. Exclude chromosomal abnormalities, associated anomalies recognized to alter survival prognosis (i.e., CDH and congenital heart disease) or presence of an underlying genetic syndrome (i.e., Fryns).
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 anomalies 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 neonates that survivedfrom delivery to hospital discharge (up to 12 months)
  • Number of Successful placement of FETO device10-60 minutes after surgery begins
  • Number of Successful removal of FETO deviceimmediately after the procedure (about 1 hour after start of surgery)
  • FETO procedure complicationsend of study (24 months)

    Complications include, Failure FETO insertion procedure, FETO device dislodgement potentially requiring a second FETO insertion, Fetal intraoperative injury, Procedural hemorrhage, Bleeding from insertion site or Abruptions, Post-procedural hemorrhage PPROM, Preterm delivery, Chorioamnion separation,Chorioamnionitis, Polyhydramnios, Oligohydramnios,Emergent removal due to obstetrical complication, Failed percutaneous or fetoscopic removal requiring cesarean section or exit procedure for removal, Neonatal death due to asphyxia if delivery before FETO removal and Non-reassuring fetal heart rate monitoring