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FETO for Severe Congenital Diaphragmatic Hernia

This study is looking at a procedure called Fetoscopic Endoluminal Tracheal Occlusion (FETO) for babies with severe Congenital Diaphragmatic Hernia (CDH). CDH is a condition where a baby's diaphragm (the muscle that separates the chest and abdomen) doesn't form completely, allowing organs to move into the chest. The FETO procedure involves placing a small balloon in the baby's windpipe while still in the womb. This study wants to see how safe and effective FETO is by comparing it to standard care. Researchers will look at how well the balloon is placed and removed, and if babies survive to leave the hospital. You may be able to join if you are pregnant, at least 18 years old, and carrying one baby with a normal genetic test result for the baby.

Study design
This is an un-blinded, non-randomized study with two groups, aiming to enroll 80 participants. It is designed to evaluate the safety and effectiveness of the FETO procedure.
What's involved
If you are in the intervention group, you would have a balloon inserted into your baby's windpipe between 27 and 30 weeks of pregnancy. The balloon would then be removed around 34 weeks of pregnancy.
Compensation
Not stated in the trial record.
Follow-up
Information about complications will be collected from when you join the study until 24 months after your baby is born. Survival will be evaluated when your baby leaves the NICU, typically 6 months to 1 year after birth.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06946576

Safety and Efficacy of Fetoscopic Endoluminal Tracheal Occlusion in Congenital Diaphragmatic Hernia

Not Yet Recruiting
PHASE3Ages 18+InterventionalTreatment
Oregon Health and Science University
~80 participants
Updated 2025-09-02 on ClinicalTrials.gov
What's tested:Fetoscopic Endoluminal Tracheal Occlusion (FETO) Procedure

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Outcomes of placement and removal of FETO device
Measured over Device placement will take place between 27 weeks 0 days and 29 weeks 6 days gestation. Removal will take place between 34 weeks 0 days and 34 weeks 6 days.
+2 more outcomes measured

Conditions

Congenital Diaphragmatic Hernia

Explore related trials

Congenital Diaphragmatic Hernia

Where it's being run

1 sites across 1 states
Oregon1

Study leadership

  • Raphael Sun, MD · PRINCIPAL_INVESTIGATOR · Oregon Health and Science University
  • Andrew Chon, MD · PRINCIPAL_INVESTIGATOR · Oregon Health and Science University

Who to contact

Women's Health Research Unit Department of Ob/Gyn
[email protected]
503-494-3666
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Pregnant person age 18 years or older
Singleton pregnancy
Normal fetal karyotype with confirmation by culture results, Chromosomal Microarray (CMA) with non-pathological variants, Whole Exome Sequencing (WES) or Whole Genome Sequencing (WGS). Results by florescence in situ hybridization (FISH) will be acceptable if the patient is \>26 weeks gestation
Gestational age at enrollment less than 29 weeks 6 days
Intrathoracic liver herniation
Isolated left Congenital Diaphragmatic Hernia (CDH) with Lung to Head Circumference Ratio (LHR) \<30% at enrollment OR isolated right CDH with LHR \<= 45% at enrollment
Cervical length by transvaginal ultrasound \>= 20 mm within 24 hours of FETO procedure
Psychosocial criteria
Able to provide informed consent

Exclusion

Patient \< 18 years of age
Multi-fetal pregnancy
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 or placenta previa
Psychosocial ineligibility precluding consent
Inability to reside within 30 minutes of OHSU
Inability to comply with the travel for the follow-up requirements of the trial
Lack of a support person (e.g., spouse, partner, mother) available to stay with the patient for the duration of the pregnancy at OHSU.
Bilateral CDH, isolated left sided CDL with LHR \>= 30% or isolated right side CDH with LHR \>45% 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
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

  • Outcomes of placement and removal of FETO deviceDevice placement will take place between 27 weeks 0 days and 29 weeks 6 days gestation. Removal will take place between 34 weeks 0 days and 34 weeks 6 days.

    Whether placement and removal of the FETO device was successful or not

  • Compare survival to discharge between FETO and expectant managementEvaluated upon discharge from the NICU (typically 6 months to 1 year after birth)

    Evaluate rates of survival to discharge from the neonatal intensive care units (NICU) between fetuses treated with the FETO and those undergoing expectant management

  • FETO ComplicationsInformation about adverse events and complications will take place from study enrollment (gestational age less than 29 weeks) to study conclusion (24 months post-birth)

    Evaluate the frequency of maternal and fetal complications associated with the FETO procedure