RecruitingNot Applicable

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

United States40 participantsStarted 2026-06-17

Plain-language summary

The purpose of the study is to determine if babies with left or right-sided CDH that undergo the FETO procedure survive more often and have fewer long-term complications than babies that have similar left or right-sided CDH that elect not to have the FETO procedure performed during pregnancy.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

FETO Intervention Arm: Inclusion Criteria: * 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) Expectant Management Arm: Inclusion Criteria: …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Compare neonatal survival to discharge in LCDH

Timeframe: 6-12 months (birth to discharge)

Compare neonatal survival to discharge in RCDH

Timeframe: 6-12 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 gestation

Timeframe: 27weeks 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 days

Timeframe: Removal prior to delivery at approximately 34 weeks of gestation

Number of FETO procedure complications

Timeframe: Balloon placement to delivery (27 weeks up to delivery approximately 40 weeks)

Trial details

NCT IDNCT07577414

SponsorDr Erin Perrone

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2036-04

Contact for this trial

Irene Carter

734-615-3883 irenestc@med.umich.edu

View on ClinicalTrials.gov More Congenital Diaphragmatic Hernia trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Compare neonatal survival to discharge in LCDH

Timeframe: 6-12 months (birth to discharge)

Compare neonatal survival to discharge in RCDH

Timeframe: 6-12 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 gestation

Timeframe: 27weeks 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 days

Timeframe: Removal prior to delivery at approximately 34 weeks of gestation

Number of FETO procedure complications

Timeframe: Balloon placement to delivery (27 weeks up to delivery approximately 40 weeks)