FETO for Congenital Diaphragmatic Hernia

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: Timothy Crombleholme

Disqualifiers: Maternal contraindication, Preterm labor, Placenta previa, 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 (CDH), although there are concerns about potential complications like tracheomegaly (enlarged windpipe) and tracheomalacia (softening of the windpipe).

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Is FETO generally safe for humans?

FETO has been shown to improve survival in infants with congenital diaphragmatic hernia, but there are concerns about potential complications like tracheomegaly (enlarged windpipe) and tracheomalacia (softening of the windpipe). Long-term safety outcomes are still being studied.

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How is the treatment FETO 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 promote lung growth before birth, which can improve survival rates. Unlike other treatments, it specifically targets lung development in the womb, but it may also lead to complications like tracheomegaly (enlarged windpipe) and tracheomalacia (softening of the windpipe).

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Eligibility Criteria

This trial is for pregnant women aged 18 and older with a single pregnancy, who can consent to treatment. It's not for those under 18, with conditions that make fetoscopic surgery risky or impossible, latex allergy, high risk of preterm labor, placenta previa, certain types of diaphragmatic hernia or major associated anomalies.

Inclusion Criteria

You are pregnant with one fetus.

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

Exclusion Criteria

I am at high risk for early labor due to a short cervix or uterine issues.

Psychosocial ineligibility, precluding consent

I have a health condition that prevents me from having surgery during pregnancy.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

FETO Procedure

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

2 weeks

Postnatal Follow-up

Participants are monitored for neonatal survival and postnatal mechanical ventilator support

12 weeks

Regular monitoring until discharge

Participant Groups

The trial tests Fetoscopic Endoluminal Tracheal Occlusion (FETO) in severe congenital diaphragmatic hernia (CDH). The goal is to improve lung growth before birth to increase the chances of newborn survival.

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:

Connecticut Children's Medical Center Hartford, CT

Who Is Running the Clinical Trial?

Timothy Crombleholme Lead Sponsor

References

1. 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.

2. 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).

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. 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).

5. 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.

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.