FETO for Congenital Diaphragmatic Hernia

(FETO Trial)

Overseen By Caitlin Clifford, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Dr Erin Perrone

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: 2

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a technique called FETO (Fetal Endoscopic Tracheal Occlusion), which involves placing a small balloon in the unborn baby's airway to address congenital diaphragmatic hernia (CDH). CDH is a serious condition where the baby's diaphragm does not form properly, affecting lung development. The trial aims to determine if FETO is safe and can improve lung growth. Pregnant women with a single baby diagnosed with severe CDH, who can live close to Michigan Medicine for regular check-ups and have support during pregnancy, may be suitable candidates. Participants should be prepared to adjust daily activities like exercise and work during the remainder of their pregnancy. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could improve outcomes for future families facing CDH.

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 healthcare provider.

What prior data suggests that this procedure is safe for treating severe congenital diaphragmatic hernia?

Research shows that Fetal Endoscopic Tracheal Occlusion (FETO) is a treatment under study to help unborn babies with congenital diaphragmatic hernia (CDH). FETO involves placing a small balloon in the baby's airway to promote lung growth before birth.

Studies have found that FETO can be a safe procedure with positive results for severe CDH cases. While outcomes have been promising, FETO is still under investigation for safety and effectiveness. Researchers have studied this method for over 30 years, providing substantial experience to guide these studies.

As with any medical procedure, risks may exist. However, current research suggests that FETO is generally well-tolerated with careful monitoring. Discuss any concerns with a healthcare provider to understand what this means for the baby. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about FETO with the Goldballoon Detachable Balloon (GOLDBAL2) for congenital diaphragmatic hernia because it offers a novel approach to treating this condition before birth. Unlike current surgical methods that often address issues after birth, FETO involves placing a balloon in the fetus's airway, which helps the lungs develop better by blocking the fluid from escaping. This proactive method aims to improve lung growth and function, offering hope for better outcomes in affected babies.

What evidence suggests that FETO with GOLDBAL2 is effective for treating congenital diaphragmatic hernia?

Research has shown that a procedure called Fetal Endoscopic Tracheal Occlusion (FETO) can significantly improve survival chances for babies with congenital diaphragmatic hernia (CDH). Studies, such as the TOTAL trials, have found that FETO promotes lung growth, crucial because CDH often results in underdeveloped lungs. Specifically, one study demonstrated that babies who underwent FETO experienced better lung growth and increased survival rates. In this trial, participants will undergo the FETO procedure, which involves placing a small balloon in the unborn baby's airway to block it, encouraging lung growth. This method has been studied for over 30 years, and the results are promising for improving outcomes in severe CDH cases. ^{2 3 4 6 7}

Who Is on the Research Team?

Erin Perrone, MD

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

This trial is for pregnant women with a baby diagnosed with severe Congenital Diaphragmatic Hernia (CDH). Participants must live within 30 miles of the Von Voigtlander Women's Hospital, have support throughout pregnancy, and be willing to follow study procedures without working or engaging in normal activities like exercise.

Inclusion Criteria

Willing to comply with restrictions of daily living including inability to exercise, have intercourse, or return to work.

Willing to reside within 30 minutes of Von Voigtlander Women's Hospital and ability to maintain follow up appointments

Meets psychosocial criteria

Exclusion Criteria

My baby has a diaphragmatic hernia, with specific lung and liver positioning.

Maternal contraindications to elective fetoscopic surgery

Maternal isoimmunization or neonatal alloimmune thrombocytopenia

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

FETO Procedure

Placement of the Goldballoon Detachable Balloon (GOLDBAL2) in the airway of the fetus between 27 weeks 0 days and 29 weeks 6 days of gestation

2-3 weeks

1 visit (in-person)

Balloon Monitoring

Weekly follow-up appointments to monitor the balloon and fetal lung growth while the balloon is in place

5-7 weeks

Weekly visits (in-person)

Balloon Removal

Removal of the balloon ideally between 34 weeks 0 days and 34 weeks 6 days of gestation

1 week

1 visit (in-person)

Follow-up

Participants are monitored for maternal complications and infant survival up to 180 days after delivery

up to 180 days postpartum

What Are the Treatments Tested in This Trial?

Interventions

• FETO with Goldballoon Detachable Balloon (GOLDBAL2) along with the Delivery Microcatheter (BALTACCI-BDPE100)

Trial Overview The trial tests Fetal Endoscopic Tracheal Occlusion (FETO) using a Goldballoon Detachable Balloon and Delivery Microcatheter on babies with CDH. It aims to see if this treatment is safe and doable at Michigan Medicine between 27-29 weeks' gestation.

How Is the Trial Designed?

Group I: FETO with GOLDBAL2 Experimental Treatment 1 Intervention

A balloon will be placed in the airway of the fetus during the FETO procedure.

FETO with Goldballoon Detachable Balloon (GOLDBAL2) along with the Delivery Microcatheter (BALTACCI-BDPE100) 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?

Dr Erin Perrone

Lead Sponsor

Trials

1

Recruited

10+

Published Research Related to This Trial

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]

In a study involving 24 medical students, those trained through in-person lectures were significantly faster at setting up instruments for balloon removal in fetal endoluminal tracheal occlusion (FETO) compared to those trained via online video (62 seconds vs 81 seconds).

However, both training methods showed no significant difference in the time taken to locate and intubate the balloon in the trachea, indicating that while in-person training may enhance setup speed, both methods are equally effective for the critical task of balloon removal.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Simulation training for urgent postnatal fetal tracheal balloon removal: Two learning methods. Lehoczky, L., Corroenne, R., Espinoza, J., et al.[2023]

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) is a promising intervention for isolated congenital diaphragmatic hernia that can promote lung growth in fetuses at high risk of postnatal death, with demonstrated feasibility and safety in several fetal surgery programs.

While FETO shows an apparent increase in survival rates compared to controls, the most common complication is preterm premature rupture of membranes, which may complicate the procedure and delivery, highlighting the need for further formal trials to evaluate its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Technical aspects of fetal endoscopic tracheal occlusion for congenital diaphragmatic hernia. Deprest, J., Nicolaides, K., Done', E., et al.[2016]

In a study of 16 cases of severe congenital diaphragmatic hernia (CDH) treated with fetoscopic endoluminal tracheal occlusion (FETO), the survival rate at 6 months was 50%, indicating a promising outcome for this prenatal intervention.

Survivors of the treatment had earlier balloon insertion and better changes in amniotic fluid levels and lung-to-head ratio compared to those who did not survive, suggesting that earlier intervention may improve outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fetal surgery using fetoscopic endoluminal tracheal occlusion for severe congenital diaphragmatic hernia: a single-center experience. Idelson, A., Tenenbaum-Gavish, K., Danon, D., et al.[2023]

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 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]

Fetoscopic endoluminal tracheal occlusion (FETO) significantly improved lung growth and respiratory function in lambs with congenital diaphragmatic hernia (CDH), as evidenced by increased lung-to-body-weight ratio and dynamic lung compliance.

Despite these improvements, FETO did not lead to significant enhancements in gas exchange during the first two hours of life, indicating that while it aids lung development, further benefits in oxygenation may be limited.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of tracheal occlusion on the neonatal cardiopulmonary transition in an ovine model of diaphragmatic hernia. DeKoninck, PLJ., Crossley, KJ., Kashyap, AJ., et al.[2019]

Citations

1. 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.

2. 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 ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06281717?cond=(DIAPHRAGMATIC%20HERNIA)%20OR%20(ZFPM2)&rank=9

Fetal Endotracheal Occlusion (FETO) in Fetuses with ... The goal of this study is to learn more about the role of Fetal Endotracheal Occlusion (FETO) as an intervention in fetuses with isolated severe congenital ...

4. mdpi.com mdpi.com/1422-0067/26/4/1639

Fetoscopic Endoluminal Tracheal Occlusion-Synergic ... Fetoscopic endoluminal tracheal occlusion (FETO) promotes lung development and offers a promising strategy against lung hypoplasia and pulmonary hypertension.

5. karger.com karger.com/fdt/article/doi/10.1159/000546839/929109/Fetoscopic-Endoluminal-Tracheal-Occlusion-in

Fetoscopic Endoluminal Tracheal Occlusion in Congenital ... The primary outcome was survival, correlated with lung growth and prematurity. Results: Among 4,524 CDH patients, 106 (2.3%) received FETO; ...

6. 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.

7. cincinnatichildrens.org cincinnatichildrens.org/service/f/fetal-care/conditions/congenital-diaphragmatic-hernia/feto

Fetoscopic Endoluminal Tracheal Occlusion (FETO) for CDH FETO is a surgical procedure to treat the most severe cases of congenital diaphragmatic hernia (CDH) that are diagnosed in utero.