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

Trial Summary

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 data supports the effectiveness of the treatment Fetal Tracheal Occlusion for Congenital Diaphragmatic Hernia?

Research shows that Fetal Tracheal Occlusion (FETO) can improve the survival of infants with congenital diaphragmatic hernia by helping their lungs grow better before birth. However, there are concerns about possible complications like changes in the trachea (windpipe) after the procedure. ^{1 2 3 4 5}

Is FETO generally safe for humans?

FETO (Fetoscopic Endoluminal Tracheal Occlusion) has been used to improve survival in infants with congenital diaphragmatic hernia, but there are concerns about potential complications like tracheomegaly (enlarged trachea) and tracheomalacia (softening of the trachea). ^{1 2 3 4 6}

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

FETO is unique because it involves placing a balloon in the fetus's trachea (windpipe) to block it, which helps the lungs grow better before birth. This approach is different from other treatments because it directly targets lung development in the womb, although it may lead to complications like tracheomegaly (enlarged windpipe) and tracheomalacia (softening of the windpipe). ^{2 3 4 7 8}

What is the purpose of this trial?

Tracheal occlusion IDE approved by FDA for congenital diaphragmatic hernia fetuses.

Research Team

Kurt Schibler, MD

Principal Investigator

CCHMC Oversight Data Safety Monitoring Committee

Eligibility Criteria

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.

You are pregnant with only one baby.

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

Exclusion Criteria

I am under 18 years old.

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

The baby has been found to have more health problems during ultrasound or other tests.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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]

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]

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

A novel translational model of percutaneous fetoscopic endoluminal tracheal occlusion - baboons (Papio spp.). [2021]

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

Severe diaphragmatic hernia treated by fetal endoscopic tracheal occlusion. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Prevalence of symptomatic tracheal morbidities after fetoscopic endoluminal tracheal occlusion: a systematic review and meta-analysis. [2023]

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

Feasibility and outcomes of fetoscopic endoluminal tracheal occlusion for severe congenital diaphragmatic hernia: A Japanese experience. [2020]

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

Fetendo-clip: a fetal endoscopic tracheal clip procedure in a human fetus. [2019]

6. Brazil pubmed.ncbi.nlm.nih.gov

[Fetoscopic tracheal occlusion for severe congenital diaphragmatic hernia: retrospective study]. [2019]

7. Germany pubmed.ncbi.nlm.nih.gov

Tracheomegaly: a complication of fetal endoscopic tracheal occlusion in the treatment of congenital diaphragmatic hernia. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Clinically relevant discordances identified after tertiary reassessment of fetuses with isolated congenital diaphragmatic hernia. [2022]