FETO for Congenital Diaphragmatic Hernia

(FETO Trial)

Overseen By Jose Peiro, MD, PhD

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Children's Hospital Medical Center, Cincinnati

Disqualifiers: Multifetal pregnancy, Chromosomal abnormalities, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: prenatal period up to 40 weeks gestation

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called Fetal Tracheal Occlusion (Fetoscopic Endoluminal Tracheal Occlusion, or FETO) for unborn babies diagnosed with congenital diaphragmatic hernia (CDH). CDH occurs when a hole in the diaphragm allows organs to move into the chest, affecting lung development. The trial aims to determine if blocking the trachea (windpipe) can promote better lung growth. It specifically targets pregnancies where the baby has CDH with the liver positioned in the chest and significant lung underdevelopment. Pregnant individuals at the appropriate stage of pregnancy and willing to remain in the Cincinnati area for the duration of their pregnancy might be suitable candidates. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research that could improve outcomes for future pregnancies affected by CDH.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this tracheal occlusion is safe for congenital diaphragmatic hernia fetuses?

Research shows that fetal tracheal occlusion (FETO) safely treats severe congenital diaphragmatic hernia (CDH) in unborn babies. Studies have found that FETO can improve health outcomes by promoting more effective lung growth in these babies.

Although researchers continue to study FETO, it has undergone testing for many years and is considered a promising treatment. These studies have not reported significant major safety issues. Overall, FETO appears well-tolerated, yielding good results for the treated babies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Fetal Tracheal Occlusion (FETO) is unique because it offers a novel way to boost lung development in fetuses with congenital diaphragmatic hernia (CDH), a condition where the diaphragm doesn't form properly, impacting lung growth. Unlike traditional treatments that might focus on managing symptoms after birth, FETO directly intervenes during pregnancy by temporarily blocking the fetal trachea. This blockage encourages the lungs to expand and develop more fully before the baby is born. Researchers are excited about FETO because it targets the problem at its source, potentially improving outcomes for babies born with CDH by enhancing their lung capacity and function from the start.

What evidence suggests that fetal tracheal occlusion is effective for congenital diaphragmatic hernia?

Research has shown that a procedure called Fetal Tracheal Occlusion (FETO) can help babies with congenital diaphragmatic hernia (CDH). In this trial, fetuses with severe or moderate CDH will receive FETO to promote lung growth. Studies indicate that FETO can improve survival chances for these infants. The procedure encourages lung development before birth, which is crucial for babies with CDH. Previous studies have demonstrated that FETO is a safe and effective option, particularly for severe cases. This treatment has been studied for over 30 years, and evidence supports its potential benefits for these babies. ^{1 2 4 6 7}

Who Is on the Research Team?

Kurt Schibler, MD

Principal Investigator

CCHMC Oversight Data Safety Monitoring Committee

Are You a Good Fit for This Trial?

This trial is for pregnant individuals carrying a single fetus with left congenital diaphragmatic hernia, who have decided against terminating the pregnancy. They must be at least 18 years old, willing to stay in Cincinnati for the pregnancy duration, and meet specific gestational age and fetal health criteria. Exclusions include additional fetal anomalies, maternal infections like HIV or Hepatitis B/C, multi-fetal pregnancy, latex allergy, risk of preterm labor.

Inclusion Criteria

The fetal heart ultrasound shows no problems.

My unborn baby has a severe lung problem detected by ultrasound.

You are pregnant with only one baby.

Exclusion Criteria

You have known issues with your placenta at the time of signing up.

I am under 18 years old.

My condition involves a diaphragmatic hernia on both sides or on the left with specific severity.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Fetuses with severe or moderate congenital diaphragmatic hernia will undergo fetal tracheal occlusion to increase lung growth

prenatal period up to 40 weeks gestation

Follow-up

Participants are monitored for survival, need for ECMO therapy, pulmonary hypertension, and neonatal morbidity

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Fetal Tracheal Occlusion

Trial Overview The trial tests Feto-Endoscopic Tracheal Occlusion (FETO), a procedure approved by FDA to treat fetuses with congenital diaphragmatic hernia. It involves temporarily blocking the fetal trachea to promote lung growth before birth.

How Is the Trial Designed?

Group I: Fetal Tracheal Occlusion Experimental Treatment 1 Intervention

Fetuses with severe or moderate congenital diaphragmatic hernia will be offered fetal tracheal occlusion to increase lung growth.

Fetal Tracheal Occlusion is already approved in United States, European Union for the following indications:

Approved in United States as FETO for:

• Congenital Diaphragmatic Hernia

Approved in European Union as FETO for:

• Congenital Diaphragmatic Hernia

Who Is Running the Clinical Trial?

Children's Hospital Medical Center, Cincinnati

Lead Sponsor

Trials

844

Recruited

6,566,000+

Published Research Related to This Trial

A systematic review of 10 studies involving 449 infants who underwent fetoscopic endoluminal tracheal occlusion (FETO) for congenital diaphragmatic hernia (CDH) found that 6% of infants born alive and 12% of those who survived to discharge experienced symptomatic tracheal complications.

These complications ranged from mild symptoms like barking cough to severe issues requiring tracheostomy, highlighting the need for ongoing monitoring of FETO survivors and the development of devices that reduce tracheal injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevalence of symptomatic tracheal morbidities after fetoscopic endoluminal tracheal occlusion: a systematic review and meta-analysis. Tho, ALW., Rath, CP., Tan, JKG., et al.[2023]

The study successfully established a percutaneous fetoscopic endoluminal reversible tracheal occlusion (FETO) model in non-human primates, which is crucial for improving fetal outcomes in cases of congenital diaphragmatic herniation.

The FETO procedure did not result in any complications such as bleeding or premature fetal membrane rupture, and it led to a significant increase in tracheal width in the treated group compared to controls, indicating its potential efficacy in mimicking human conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A novel translational model of percutaneous fetoscopic endoluminal tracheal occlusion - baboons (Papio spp.). Mari, G., Deprest, J., Schenone, M., et al.[2021]

Fetoscopic endoluminal tracheal occlusion (FETO) is a feasible and safe procedure for treating severe congenital diaphragmatic hernia (CDH), with successful balloon insertion in all 11 cases studied, and no severe maternal adverse events reported.

The procedure resulted in a 45% survival rate at 90 days of age and at discharge for the treated fetuses, indicating its potential effectiveness in promoting fetal lung growth in cases of isolated left-sided CDH.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and outcomes of fetoscopic endoluminal tracheal occlusion for severe congenital diaphragmatic hernia: A Japanese experience. Wada, S., Ozawa, K., Sugibayashi, R., et al.[2020]

Fetal endoscopic tracheal occlusion (FETO) is a treatment for severe congenital diaphragmatic hernia that can lead to complications such as tracheomegaly in infants, as observed in a series of five cases.

This study highlights a new potential risk associated with FETO, suggesting that the compliant fetal airway may be damaged by balloon occlusion, warranting careful evaluation of the trachea in infants who underwent this procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tracheomegaly: a complication of fetal endoscopic tracheal occlusion in the treatment of congenital diaphragmatic hernia. McHugh, K., Afaq, A., Broderick, N., et al.[2021]

Fetal endoscopic tracheal occlusion (FETO) was performed successfully in 210 cases of congenital diaphragmatic hernia (CDH), with a high success rate of balloon placement (96.7%) and a median procedure duration of 10 minutes.

While FETO is associated with a significant risk of spontaneous preterm prelabor rupture of membranes (47.1%) and preterm delivery, it notably improves survival rates for affected fetuses, increasing survival from 24.1% to 49.1% for left-sided CDH and from 0% to 35.3% for right-sided CDH.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Severe diaphragmatic hernia treated by fetal endoscopic tracheal occlusion. Jani, JC., Nicolaides, KH., Gratacós, E., et al.[2022]

Fetal tracheal occlusion, performed using advanced fetoscopic techniques, has been shown to accelerate lung growth and correct severe lung underdevelopment (pulmonary hypoplasia) in fetuses with congenital diaphragmatic hernia.

This innovative approach, referred to as 'Fetendo,' demonstrates the potential of fetoscopy not just for diagnosis but also for effective treatment in fetal medicine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fetendo-clip: a fetal endoscopic tracheal clip procedure in a human fetus. VanderWall, KJ., Skarsgard, ED., Filly, RA., et al.[2019]

In a study of 129 patients assessed for severe isolated congenital diaphragmatic hernia (iCDH), significant discrepancies were found between initial evaluations and assessments at the fetal surgery center, with 33% showing discordant lung size and 10% having undiagnosed associated anomalies.

Despite the high eligibility for fetoscopic endoluminal tracheal occlusion (FETO) surgery (94%), 26% of parents chose to terminate the pregnancy, highlighting the complexity of decision-making in cases of iCDH.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinically relevant discordances identified after tertiary reassessment of fetuses with isolated congenital diaphragmatic hernia. Done, E., Gucciardo, L., Van Mieghem, T., et al.[2022]

Fetoscopic tracheal occlusion (FETO) is a minimally invasive procedure that significantly aids lung development in fetuses with congenital diaphragmatic hernia, resulting in a neonatal survival rate of 60.7% among 28 pregnant women studied.

The anesthetic approach used during FETO, which included a combination of epidural anesthesia and fetal anesthesia, was found to be safe and effective, allowing for successful management of both maternal and fetal needs during the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Fetoscopic tracheal occlusion for severe congenital diaphragmatic hernia: retrospective study]. Braga, AFA., da Silva Braga, FS., Nascimento, SP., et al.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11627046/

Feasibility, safety, and outcome of fetoscopic endoluminal ... Our data have shown that FETO represents a viable option for severe type of CDH fetuses with reasonable outcome.

2. nejm.org nejm.org/doi/full/10.1056/NEJMoa2027030

Randomized Trial of Fetal Surgery for Severe Left ... Previous studies have suggested that FETO improves survival among infants with congenital diaphragmatic hernia. Two small, single-center, ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06946576

Safety and Efficacy of Fetoscopic Endoluminal Tracheal ... The purpose of this study is to evaluate the safety and efficacy of Fetoscopic Endoluminal Tracheal Occlusion (FETO) in cases of severe Congenital Diaphragmatic ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8192998/

Fetal endoscopic tracheal occlusion for congenital ... Fetal intervention for fetuses with congenital diaphragmatic hernia (CDH) has been investigated for over 30 years and is summarized in this manuscript.

5. childrenscolorado.org childrenscolorado.org/advances-answers/recent-articles/fetoscopic-endoluminal-tracheal-occlusion/

FETO for Congenital Diaphragmatic Hernia FETO is a minimally invasive fetal surgery aimed to enhance lung growth and improve survival for patients with severe congenital diaphragmatic hernia (CDH).

6. nejm.org nejm.org/doi/full/10.1056/NEJMoa035005

A Randomized Trial of Fetal Endoscopic Tracheal ... Experimental and clinical data suggest that fetal endoscopic tracheal occlusion to induce lung growth may improve the outcome of severe congenital ...

7. obgyn.onlinelibrary.wiley.com obgyn.onlinelibrary.wiley.com/doi/full/10.1002/pd.6803

Fetal Endoscopic Tracheal Occlusion (FETO) for Left and ... Data from the TOTAL (tracheal occlusion to accelerate lung growth) trials have demonstrated significant improvement in survival following fetal ...