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FETO for Congenital Diaphragmatic Hernia (CDH)

This study is looking at a treatment called Fetoscopic Endoluminal Tracheal Occlusion (FETO) for babies with severe congenital diaphragmatic hernia (CDH). CDH is a birth defect where a hole in the diaphragm (breathing muscle) allows abdominal organs to move into the chest, preventing the lungs from growing properly. The study uses a device called the GoldBAL2 Balloon and BALTACCIBDPE100 Catheter to temporarily block the baby's airway before birth, aiming to help the lungs develop. Researchers want to see if this treatment is safe and improves survival rates for babies with CDH. You may be able to join if you are pregnant, at least 18 years old, carrying one baby, and your baby has a normal genetic test result. The study is currently unclear on its recruitment status.

Study design
This is an interventional study planning to enroll up to 80 participants. It is a Phase III trial, comparing an intervention group to a control group.
What's involved
If you join the intervention group, you will have two procedures: one to place a balloon in your baby's airway between 27 and 29 weeks of pregnancy, and another to remove it between 34 and 34.5 weeks. You must stay near the Children's Hospital of Philadelphia (CHOP) from balloon placement until delivery.
Compensation
Not stated in the trial record.
Follow-up
The study will track successful device placement and removal, and compare neonatal survival rates for 24 months after birth.

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NCT06884423

Safety and Efficacy of FETO in CDH: A Phase III Trial

Recruiting
NAAges 18+InterventionalTreatment
Holly L Hedrick, MD
~80 participants
Updated 2026-07-22 on ClinicalTrials.gov
What's tested:FETO with GoldBAL2 Balloon and BALTACCIBDPE100 Catheter

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Successful placement and removal of the FETO Device
Measured over 24 months
+3 more outcomes measured

Conditions

Congenital Diaphragmatic Hernia
Pulmonary Hypoplasia

Explore related trials

Congenital Diaphragmatic Hernia

Where it's being run

1 sites across 1 states
Pennsylvania1

Study leadership

  • Holly L Hedrick, MD, FACS · PRINCIPAL_INVESTIGATOR · Children's Hospital of Philadelphia

Who to contact

Holly L Hedrick, MD, FACS
[email protected]
1-800-468-8376
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Exclusion

Inability to reside within 30 minutes of the Children's Hospital of Philadelphia (CHOP) 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 CHOP 6. Bilateral CDH, isolated left sided CDH with O/E LHR greater than or equal to 30% (measured at 18\^0 to 29\^5 weeks), isolated right sided CDH with O/E LHR greater than 45% (measured at 180 to 295 weeks), as determined by ultrasound 7. No Liver herniation into thoracic cavity. 8. Additional fetal anomaly by ultrasound, magnetic resonance imaging (MRI), or echocardiogram at the fetal treatment center. Exclude chromosomal abnormalities, associated anomalies recognized to alter survival prognosis (ie. CDH and congenital heart disease) or presence of an underlying genetic syndrome (ie. Fryns). 9. Maternal contraindication to fetoscopic surgery or severe maternal medical condition in pregnancy 10. History of incompetent cervix with or without cerclage 11. Placental abnormalities (previa, abruption, accrete) known at time of enrollment. 12. Maternal-fetal Rh isoimmunization, Kell sensitization or neonatal alloimmune thrombocytopenia affecting the current pregnancy. 13. 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. 14. Uterine anomaly such as large or multiple fibroids or mullerian duct abnormality 15. There is no safe or technically feasible fetoscopic approach to balloon placement. 16. 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

  • Successful placement and removal of the FETO Device24 months

    Evalutation of successful placement and removal of the fetoscopic endoluminal tracheal occlusion (FETO) device in cases of intrathoracic liver herniation with isolated left congenital diaphragmatic hernia (LCDH) with observed/expected lung to head ratio (O/E LHR) \< 30% or isolated right congenital diaphragmatic hernia (RCDH) with O/E LHR \< 45%.

  • Comparison of neonatal survival rates of LCDH cases between intervention and control groups24 months

    Compare survival to discharge from the neonatal intensive care units (NICU), between fetuses with intrathoracic liver herniation and isolated LCDH with O/E LHR \< 30% that receive FETO procedure performed at 27\^0 to 29\^6 weeks gestation to concurrent patients with intrathoracic liver herniation, isolated LCDH and O/E LRH \< 30% that undergo expectant management.

  • Comparison of neonatal survival rates of RCDH cases between intervention and control groups24 months

    Compare the neonatal survival rate to discharge from the neonatal intensive care units (NICU), between fetuses with intrathoracic liver herniation, isolated RCDH with O/E LHR \< 45% that undergo FETO procedure performed at 27\^0 to 29\^6 weeks gestation to concurrent patients with intrathoracic liver herniation, isolated RCDH and O/E LHR \< 45% that proceed with expectant management.

  • Assessment of complications associated with the FETO intervention24 months

    Evaluate the frequency of maternal and fetal complications associated with the FETO intervention.