FETO for Congenital Diaphragmatic Hernia

(FETO Trial)

Overseen By Amy Powne, MSN, RN

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of California, Davis

Disqualifiers: Multi-fetal pregnancy, Preterm labor, HIV, 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 treatment called FETO (Fetal Endoscopic Tracheal Occlusion), which involves placing a small balloon in a fetus's airway to aid lung development in cases of severe congenital diaphragmatic hernia (CDH). The researchers aim to determine if this procedure is safe and practical for unborn babies with this condition. Pregnant women carrying a baby diagnosed with severe CDH, who live within 30 minutes of UC Davis Medical Center, may be eligible. Participants must be prepared for weekly follow-ups and adjust their daily activities, such as stopping work and exercise, for the remainder of the pregnancy. This unphased trial offers a unique opportunity to contribute to groundbreaking research that could improve outcomes for future families facing similar challenges.

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. 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 CDH?

Research shows that Fetal Endoscopic Tracheal Occlusion (FETO) using the Goldballoon Detachable Balloon (GOLDBAL2) is generally safe for treating severe congenital diaphragmatic hernia (CDH) in unborn babies. Studies have found that FETO can be a beneficial option with positive outcomes. It aids in the better growth of the baby's lungs when the diaphragm, the muscle that assists in breathing, doesn't develop properly.

However, some risks exist. Certain studies mention that the procedure can cause tracheomegaly, where the windpipe enlarges beyond normal size, potentially leading to breathing problems. These risks must be weighed against the potential benefits, especially in severe CDH cases with limited alternatives. Overall, FETO is considered a promising treatment with established safety information, but like any procedure, it carries possible risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the FETO procedure with the GOLDBAL2 balloon because it offers a unique approach for treating congenital diaphragmatic hernia (CDH) before birth. Unlike traditional postnatal surgical interventions, this method involves placing a detachable balloon in the fetus's airway, which encourages lung growth while the baby is still in the womb. This proactive approach aims to improve lung development and increase survival rates for babies with CDH, offering a potential game-changer in prenatal care for this challenging condition.

What evidence suggests that FETO with GOLDBAL2 is effective for treating severe CDH?

Research has shown that a procedure called Fetal Endoscopic Tracheal Occlusion (FETO) can improve survival in babies with congenital diaphragmatic hernia (CDH). Specifically, data from the TOTAL trials indicated that FETO significantly increases survival rates by promoting lung growth before birth. Studies have also found that FETO can reduce lung problems and high blood pressure in the lungs, common in CDH. In this trial, participants will undergo the FETO procedure, which involves placing a small balloon in the baby's airway to support lung development. Overall, early findings suggest FETO holds promise for improving outcomes in severe CDH cases. ^{2 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for pregnant women over 18 with a single pregnancy and severe Congenital Diaphragmatic Hernia (CDH) in the fetus. Participants must live within 30 minutes of UC Davis Medical Center, have no major fetal cardiac defects or additional abnormalities, and agree to lifestyle restrictions including not working or engaging in exercise and intercourse.

Inclusion Criteria

My unborn baby has severe lung issues due to CDH, with a very low lung-to-head ratio.

Singleton pregnancy

I have someone to stay with me near UC Davis Medical Center during my pregnancy.

Exclusion Criteria

Identifiable issues of social instability or compliance with the protocol will exclude her as a potential candidate

Maternal contraindications to elective fetoscopic surgery

My baby has been diagnosed with a condition that could affect their health after birth.

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 until removal

5-7 weeks

Weekly visits (in-person)

Balloon Removal

Removal of the Goldballoon Detachable Balloon ideally around 34 weeks of gestation

1 week

1 visit (in-person)

Follow-up

Participants are monitored for maternal complications and infant survival up to 4-6 weeks postpartum

4-6 weeks

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 study tests Fetal Endoscopic Tracheal Occlusion using GOLDBAL2 balloon and BALTACCI-BDPE100 microcatheter on fetuses with CDH. The procedure occurs between 27-29 weeks' gestation, with removal around week 34, monitored by UC Davis Medical Center.

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?

University of California, Davis

Lead Sponsor

Trials

958

Recruited

4,816,000+

Published Research Related to This Trial

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) 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]

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) 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) 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]

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 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]

Citations

1. 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 ...

2. 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.

3. 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; ...

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. 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 ...

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. 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 ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0022480424006917

Neonatal Airway Management and Outcomes Following ... Fetoscopic endoluminal tracheal occlusion (FETO) has been shown to improve survival and pulmonary hypertension, however, is associated with tracheomegaly.