Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

(FETO Trial)

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Mauro H. Schenone

Disqualifiers: Multi-fetal pregnancy, Latex allergy, Preterm labor, 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

20 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this research is to gather information on the safety and effectiveness of a procedure called Fetoscopic Endoluminal Tracheal Occlusion (FETO) at Mayo Clinic. The intent of the FETO procedure is to improve development of the lungs in fetuses diagnosed with severe congenital diaphragmatic hernia (CDH).

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. It's best to discuss your specific medications with the trial team to get a clear answer.

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

Research suggests that Fetal Endoscopic Tracheal Occlusion (FETO) may help improve lung growth and survival rates in babies with severe congenital diaphragmatic hernia (CDH). Studies have shown that this treatment can enhance prenatal lung development, potentially leading to better outcomes compared to standard care. ^{1 2 3 4 5}

Is fetal endoscopic tracheal occlusion (FETO) generally safe for humans?

Fetal endoscopic tracheal occlusion (FETO) has been used to help babies with congenital diaphragmatic hernia (CDH), but there are concerns about possible complications like tracheomegaly (enlarged windpipe) and tracheomalacia (softening of the windpipe). ^{1 2 3 6 7}

How is the treatment Fetal Endoscopic Tracheal Occlusion (FETO) different from other treatments for congenital diaphragmatic hernia?

Fetal Endoscopic Tracheal Occlusion (FETO) is unique because it involves a minimally invasive procedure where a small balloon is placed in the fetus's trachea (windpipe) to promote lung growth before birth, which is different from standard treatments that typically occur after birth. ^{1 2 3 8 9}

Research Team

Mauro Schenone, MD

Principal Investigator

Mayo Clinic

Eligibility Criteria

This trial is for pregnant individuals with a fetus diagnosed with severe left-sided congenital diaphragmatic hernia (CDH) and poor lung development. Eligible participants must be able to give informed consent, have had appropriate counseling, carry a single pregnancy with normal fetal genetics, and be able to stay near the Mayo Clinic for the duration of the pregnancy.

Inclusion Criteria

Patient is willing and able to give informed consent

Singleton pregnancy

My unborn baby has a severe left-sided diaphragmatic hernia.

Exclusion Criteria

Maternal-fetal Rh isoimmunization, Kell sensitization or neonatal alloimmune thrombocytopenia affecting the current pregnancy

It's not safe or possible for me to have a balloon placed via fetoscopy.

Participation in another intervention study that influences maternal and fetal morbidity and mortality or participation in this trial in a previous pregnancy

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

FETO Procedure

Participants undergo fetal endoscopic tracheal occlusion (FETO) surgical procedure between 27 weeks 0 days and 29 weeks 6 days gestation

3 weeks

Balloon Retrieval

Antenatal removal of the balloon is performed

Up to 34 weeks gestation

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of fetal oxygen dependency, pulmonary hypertension, and other complications

Up to 24 months post partum

Treatment Details

Interventions

• Fetal Endoscopic Tracheal Occlusion

Trial Overview The trial tests Fetoscopic Endoluminal Tracheal Occlusion (FETO), using specialized instruments like a fetoscope and detachable balloon to improve lung growth in fetuses with CDH. The procedure's safety and effectiveness are being studied at Mayo Clinic.

Participant Groups

Group I: FETO Group Experimental Treatment 3 Interventions

Participants will undergo fetal endoscopic tracheal occlusion (FETO) surgical procedure between 27 weeks 0 days and 29 weeks 6 days gestation.

Fetal Endoscopic Tracheal Occlusion 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)

Who Is Running the Clinical Trial?

Mauro H. Schenone

Lead Sponsor

Trials

2

Recruited

100+

Findings from Research

In a randomized trial involving 24 pregnant women with fetuses diagnosed with severe congenital diaphragmatic hernia, fetal endoscopic tracheal occlusion did not improve survival rates compared to standard postnatal care, with survival rates of 73% and 77% respectively.

The intervention group experienced significantly more complications, including premature rupture of membranes and earlier delivery, indicating that tracheal occlusion may pose additional risks without providing survival benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized trial of fetal endoscopic tracheal occlusion for severe fetal congenital diaphragmatic hernia. Harrison, MR., Keller, RL., Hawgood, SB., et al.[2022]

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 Endoscopic Tracheal Occlusion (FETO) significantly improved survival rates at 28 days and reduced the length of ventilatory support in neonates with congenital diaphragmatic hernia (CDH) and moderate lung hypoplasia, based on a study of 58 cases (29 treated with FETO and 29 controls).

While the overall survival at 6 months was not significantly different, the FETO group had a lower gestational age at delivery and a shorter NICU stay, indicating that FETO may reduce neonatal respiratory morbidity in affected fetuses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of fetal endoscopic tracheal occlusion in fetuses with congenital diaphragmatic hernia and moderate lung hypoplasia. Cruz-Martínez, R., Shazly, S., Martínez-Rodríguez, M., 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]

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) using a 1.0-mm fetoscope was successfully performed in 16 fetuses with severe congenital diaphragmatic hernia (CDH), leading to a significant increase in neonatal survival rates (52.9% in the FETO group vs. 5.6% in the control group).

The study also found that FETO reduced the incidence of severe pulmonary arterial hypertension in infants, with 47.1% of the FETO group affected compared to 88.9% in the control group, indicating a potential improvement in neonatal outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison between fetal endoscopic tracheal occlusion using a 1.0-mm fetoscope and prenatal expectant management in severe congenital diaphragmatic hernia. Ruano, R., Duarte, SA., Pimenta, EJ., et al.[2016]

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]

References

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

A randomized trial of fetal endoscopic tracheal occlusion for severe fetal congenital diaphragmatic hernia. [2022]

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

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

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

Impact of fetal endoscopic tracheal occlusion in fetuses with congenital diaphragmatic hernia and moderate lung hypoplasia. [2022]

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

Survival of severe congenital diaphragmatic hernia has morbid consequences. [2007]

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

Heterogeneous Response in Rabbit Fetal Diaphragmatic Hernia Lungs After Tracheal Occlusion. [2021]

6. England pubmed.ncbi.nlm.nih.gov

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

7. Switzerland pubmed.ncbi.nlm.nih.gov

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

8. Switzerland pubmed.ncbi.nlm.nih.gov

Comparison between fetal endoscopic tracheal occlusion using a 1.0-mm fetoscope and prenatal expectant management in severe congenital diaphragmatic hernia. [2016]

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

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