Fetal Surgery for Congenital Diaphragmatic Hernia

(FETO Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Timothy Crombleholme, MD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Connecticut Children's Medical Center

Disqualifiers: Maternal medical condition, Preterm labor, others

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

The rationale for fetal therapy in severe congenital diaphragmatic hernia (CDH) is to restore adequate lung growth for neonatal survival.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Fetoscopic Endoluminal Tracheal Occlusion (FETO) for congenital diaphragmatic hernia?

Research shows that FETO can improve the survival of infants with severe congenital diaphragmatic hernia by promoting lung growth and development, although it may lead to complications like tracheomegaly (enlarged trachea) and tracheomalacia (softening of the trachea).

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Is FETO generally safe for humans?

Fetoscopic Endoluminal Tracheal Occlusion (FETO) is a treatment that can help babies with severe congenital diaphragmatic hernia, but it may lead to complications like tracheomegaly (enlarged windpipe) and tracheomalacia (softening of the windpipe). There are also concerns about preterm delivery (early birth) as a result of the procedure.

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How is the FETO treatment different from other treatments for congenital diaphragmatic hernia?

FETO is a unique treatment for congenital diaphragmatic hernia because it involves a minimally invasive procedure where a balloon is placed in the fetus's trachea (windpipe) to help the lungs develop better before birth. This approach is different from traditional treatments that usually occur after birth and focus on surgical repair of the diaphragm.

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Eligibility Criteria

This trial is for pregnant women aged 18 or older with a single pregnancy and a fetus diagnosed with severe left-sided Congenital Diaphragmatic Hernia (CDH) where the liver has moved up into the chest. The baby must have significant lung underdevelopment, confirmed by ultrasound before 29 weeks + 6 days of gestation, and a normal karyotype.

Inclusion Criteria

I am a pregnant woman, 18 or older, and can give consent.

My unborn baby has been diagnosed with a left-sided CDH and the liver is positioned upwards.

Gestation at enrollment prior to 29 wks plus 6 days

Exclusion Criteria

I am pregnant and under 18.

My diaphragmatic hernia is right-sided, bilateral, or a severe left-sided with specific lung-to-head ratio.

I cannot have surgery using a scope due to technical reasons.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Fetoscopic Endoluminal Tracheal Occlusion (FETO) procedure is performed to promote lung growth in fetuses with severe left congenital diaphragmatic hernia

2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including postnatal mechanical ventilator support

4 weeks

Participant Groups

The trial is testing Fetoscopic Endoluminal Tracheal Occlusion (FETO), which is a prenatal surgery aiming to improve lung growth in fetuses with severe CDH by temporarily blocking their trachea.

Group I: Fetoscopic Endoluminal Tracheal Occlusion (FETO) Experimental Treatment 1 Intervention

An un-blinded non-randomized single arm pilot study of FETO in fetuses with congenital diaphragmatic hernia (CDH)

Fetoscopic Endoluminal Tracheal Occlusion (FETO) is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as FETO for:

• Severe congenital diaphragmatic hernia (CDH)

🇪🇺 Approved in European Union as FETO for:

• Severe congenital diaphragmatic hernia (CDH)

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Medical City Children's Hospital Dallas, TX

Who Is Running the Clinical Trial?

Connecticut Children's Medical Center Lead Sponsor

Medical City Children's Hospital Lead Sponsor

References

1. Germany pubmed.ncbi.nlm.nih.gov

Tracheomegaly: a complication of fetal endoscopic tracheal occlusion in the treatment of congenital diaphragmatic hernia. [2021] Fetal endoscopic tracheal occlusion (FETO) is a promising treatment for severe congenital diaphragmatic hernia, a condition that carries significant morbidity and mortality. It is hypothesised that balloon occlusion of the fetal trachea leads to an improvement in lung growth and development. The major documented complications of FETO to date are related to preterm delivery.

2. England pubmed.ncbi.nlm.nih.gov

Prevalence of symptomatic tracheal morbidities after fetoscopic endoluminal tracheal occlusion: a systematic review and meta-analysis. [2023] Fetoscopic endoluminal tracheal occlusion (FETO) has been shown to improve survival of infants with congenital diaphragmatic hernia (CDH). However, there are concerns that FETO may lead to tracheomegaly, tracheomalacia and related complications.

3. United States pubmed.ncbi.nlm.nih.gov

Randomized Trial of Fetal Surgery for Moderate Left Diaphragmatic Hernia. [2022] Fetoscopic endoluminal tracheal occlusion (FETO) has been associated with increased postnatal survival among infants with severe pulmonary hypoplasia due to isolated congenital diaphragmatic hernia on the left side, but data are lacking to inform its effects in infants with moderate disease.

4. Australia pubmed.ncbi.nlm.nih.gov

Feasibility and outcomes of fetoscopic endoluminal tracheal occlusion for severe congenital diaphragmatic hernia: A Japanese experience. [2020] To present the feasibility, safety and outcomes of fetoscopic endoluminal tracheal occlusion (FETO) for the treatment of severe congenital diaphragmatic hernia (CDH).

5. England pubmed.ncbi.nlm.nih.gov

Severe diaphragmatic hernia treated by fetal endoscopic tracheal occlusion. [2022] To examine operative and perinatal aspects of fetal endoscopic tracheal occlusion (FETO) in congenital diaphragmatic hernia (CDH).

6. Switzerland pubmed.ncbi.nlm.nih.gov

A novel translational model of percutaneous fetoscopic endoluminal tracheal occlusion - baboons (Papio spp.). [2021] Percutaneous fetoscopic endoluminal reversible tracheal occlusion (FETO) was developed to prevent the pulmonary complications of fetal congenital diaphragmatic herniation. There is an urgent need to establish the closest to human translational model of FETO in order to improve fetal outcomes and to determine new clinical approaches and applications.

7. England pubmed.ncbi.nlm.nih.gov

Clinically relevant discordances identified after tertiary reassessment of fetuses with isolated congenital diaphragmatic hernia. [2022] Fetoscopic endoluminal tracheal occlusion (FETO) may improve outcome of severe isolated congenital diaphragmatic hernia (iCDH). We aimed to identify any discrepancy between initial assessment at the referring hospital and the evaluation at the fetal surgery center, and to document parental decisions following counseling for fetal surgery.

8. United States pubmed.ncbi.nlm.nih.gov

Morbidity in children after fetoscopic endoluminal tracheal occlusion for severe congenital diaphragmatic hernia: Results from a multidisciplinary clinic. [2023] Although fetoscopic endoluminal tracheal occlusion (FETO) was recently shown to improve survival in a multicenter, randomized trial of severe congenital diaphragmatic hernia (CDH), morbidity outcomes remain essentially unknown. The purpose of this study was to assess long-term outcomes in children with severe CDH who underwent FETO.