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FETO for Congenital Diaphragmatic Hernia (CDH)

This study is looking at whether a procedure called Fetoscopic Endoluminal Tracheal Occlusion (FETO) can help babies born with Congenital Diaphragmatic Hernia (CDH) survive more often and have fewer long-term problems. CDH is a condition where a baby's diaphragm (the muscle that separates the chest from the abdomen) doesn't form completely, allowing organs to move into the chest. The FETO procedure involves placing a special balloon, the Goldballoon Detachable Balloon, into the baby's windpipe while still in the womb, between 27 and 29 weeks of pregnancy. The balloon is removed around 34 weeks. Researchers want to see if babies who have this procedure survive to hospital discharge more often than those who don't. They are also tracking how often the balloon is successfully placed. This study is for pregnant women aged 18 or older with a single baby diagnosed with CDH. The study plans to enroll 40 participants, and its current status is unclear.

Study design
This interventional study plans to enroll 40 participants to compare outcomes for babies with CDH who receive the FETO procedure versus those who do not.
What's involved
Participants would undergo the FETO procedure, which involves placing a balloon between 27 and 29 weeks of gestation and removing it around 34 weeks.
Compensation
Not stated in the trial record.
Follow-up
Neonatal survival to discharge will be measured between 6 and 12 months after birth.

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NCT07577414

Safety and Efficacy of Fetoscopic Endoluminal Tracheal Occlusion (FETO) in Congenital Diaphragmatic Hernia (CDH)

Recruiting
NAAges 18+InterventionalTreatment
Dr Erin Perrone
~40 participants
Updated 2026-06-29 on ClinicalTrials.gov
What's tested:FETO with Goldballoon Detachable Balloon (GOLDBAL2) along with the Delivery Microcatheter (BALTACCI-BDPE100)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Compare neonatal survival to discharge in LCDH
Measured over 6-12 months (birth to discharge)
+4 more outcomes measured

Conditions

Congenital Diaphragmatic Hernia

Explore related trials

Congenital Diaphragmatic Hernia

Where it's being run

1 sites across 1 states
Michigan1

Study leadership

  • Erin Perrone, MD · PRINCIPAL_INVESTIGATOR · University of Michigan

Who to contact

Irene Carter
[email protected]
734-615-3883
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Provision of signed and dated informed consent form
Stated willingness to comply with all study procedures and availability (meets psychosocial criteria below) for the duration of the study
Pregnant women, age 18 years and older
Singleton pregnancy
Normal fetal karyotype, Chromosomal Microarray (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 prior to 29w6d
Fetal CDH with intrathoracic liver herniation with either:
Isolated left CDH with Observed/Expected (o/e) Lung to Head Ratio (LHR) \<30% at enrollment (18w0d-29w5d)
Isolated right CDH with o/e LHR \<45% at enrollment (18w0d-29w5d)
Cervical length by transvaginal ultrasound \>20 mm within 24hours of FETO procedure
Meets psychosocial criteria
Willing to reside within 30 minutes of Von Voigtlander Women's Hospital and ability to maintain follow up appointments
Patient has a support person (e.g. spouse, partner, friend, parent) that is available to stay with participant for the duration of the pregnancy near Von Voigtlander Women's Hospital
Willing to comply with restrictions of daily living including inability to exercise, have intercourse, or return to work (work from home approved by Principal Investigator is okay)
Provision of signed and dated informed consent form
Stated willingness to comply with all study procedures and availability (meets psychosocial criteria below) for the duration of the study
Pregnant women, age 18 years and older
Singleton pregnancy
Normal fetal karyotype, CMA with non-pathologic variants, WES or WGS. Results by fluorescence in situ hybridization (FISH) will be acceptable if the patient is \>26 weeks. (non-intervention arm can have karyotype or microarray prenatally or postnatally)
Gestational age at enrollment prior to 29w6d
Fetal CDH with intrathoracic liver herniation with either:
Isolated left CDH with o/e LHR \<30% at enrollment (18w0d-29w5d)
Isolated right CDH with o/e LHR \<45% at enrollment (18w0d-29w5d)
Meets psychosocial criteria
Ability to maintain follow up appointments

Exclusion

Patient \<18 years of age
Multi-fetal pregnancy
History of natural rubber latex allergy
Preterm labor, short cervix (\<20mm within 24 hours of FETO balloon insertion procedure), or uterine anomaly strongly predisposing to preterm labor, placenta previa
History of incompetent cervix with or without cerclage
Psychosocial ineligibility
Inability to reside within 30 minutes of Von Voigtlander Women's Hospital or inability to maintain follow up appointments
Social work will meet with each patient to evaluate the social situation and support system. Identifiable issues of social instability or compliance with the protocol will exclude participant as a potential candidate (per protocol).
Bilateral CDH, isolated Left Congenital Diaphragmatic Hernia (LCDH) with o/e LHR \> 30% (measured at 180 to 295 weeks), isolated Right Congenital Diaphragmatic Hernia (RCDH) with o/e LHR \>45% (measured at 180 to 295 weeks) as determined by ultrasound
No liver herniation into the thoracic cavity.
Additional fetal anomaly or genetic/chromosomal abnormalities 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 contraindications to elective fetoscopic surgery or severe maternal medical condition in pregnancy
Placental abnormalities (previa, abruption, accreta) known at time of enrollment and/or surgery
Maternal-fetal Rh isoimmunization, Kell sensitization, or neonatal alloimmune thrombocytopenia affecting the current pregnancy
Maternal Human Immunodeficiency Virus (HIV), Hepatitis B with positive surface antigen, Hepatitis C with presence of virus in maternal blood due to risk of fetal transmission during the procedure. If the patient's HIV or Hepatitis status is unknown, the patient must be tested and found to have negative results before enrollment
No safe or technically feasible fetoscopic approach to balloon placement
Uterine anomalies such as large fibroids or Mullerian duct abnormality
Participation in another intervention study that influences maternal and fetal morbidity and mortality or participation in this trial in a previous pregnancy
Patient \<18 years of age
Multi-fetal pregnancy
Preterm labor, short cervix (\<20mm), or uterine anomaly strongly predisposing to preterm labor, placenta previa
History of incompetent cervix with or without cerclage
Psychosocial ineligibility
Inability to maintain follow up appointments
Social work will meet with each patient to evaluate the social situation and support system. Identifiable issues of social instability or compliance with the protocol will exclude participant as a potential candidate.
Bilateral CDH, isolated LCDH with o/e LHR \> 30% (measured at 180 to 295 weeks), isolated RCDH with o/e LHR \>45% (measured at 180 to 295 weeks), or any isolated CDH without intrathoracic liver herniation as determined by ultrasound
Additional fetal anomaly or genetic/chromosomal abnormalities recognized to alter survival prognosis (i.e. congenital heart disease) or presence of an underlying genetic syndrome (i.e. Fryns) by ultrasound, Magnetic Resonance Imaging (MRI) or echocardiogram at the fetal treatment center Placental abnormalities (per protocol)
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

  • Compare neonatal survival to discharge in LCDH6-12 months (birth to discharge)
  • Compare neonatal survival to discharge in RCDH6-12 months (birth to discharge)
  • Number of successful placements the of FETO balloon Gestational age of 27 weeks 0 days gestation to 29 weeks 6 days gestation27weeks 0 days gestation to 29 weeks 6 days gestation
  • Number of successful retrievals/puncture of the FETO balloon Gestational age of 33 weeks 0 days to 35 weeks 0 daysRemoval prior to delivery at approximately 34 weeks of gestation
  • Number of FETO procedure complicationsBalloon placement to delivery (27 weeks up to delivery approximately 40 weeks)

    FETO procedure complications include: Failure of the 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; Preterm premature rupture of membranes; Preterm delivery; Chorioamnion separation; Chorioamnionitis; Polyhydramnios; Oligohydramnios; Emergent removal due to obstetrical complication; Failed percutaneous or fetoscopic removal requiring cesarean section or Ex-Utero Intrapartum Therapy(EXIT) procedure for removal; Neonatal death due to asphyxia if delivery before FETO removal; Non-reassuring fetal heart rate monitoring.