FETO Therapy for Congenital Diaphragmatic Hernia

(FETO Trial)

Overseen By James E Fisher, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Children's Hospitals and Clinics of Minnesota

Disqualifiers: Twin pregnancy, Right-sided CDH, Maternal HIV, others

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

Approved in 1 Jurisdiction 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 explores a new treatment called Fetoscopic Endoluminal Tracheal Occlusion (FETO) for fetuses with a severe form of congenital diaphragmatic hernia (CDH). The goal is to increase lung volume before birth, potentially improving survival rates. It targets pregnant individuals with a single fetus diagnosed with severe left-sided CDH. Participants must stay locally near the trial site and have supportive family or friends during the process. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could improve outcomes for future patients.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, it does mention that you should not be using illicit drugs or abusing over-the-counter drugs.

What prior data suggests that FETO therapy is safe for fetuses with congenital diaphragmatic hernia?

Research has shown that FETO therapy, an experimental treatment for severe cases of congenital diaphragmatic hernia (CDH) in unborn babies, is generally safe. Studies have found that it can improve survival rates for these babies after birth. However, some reports have noted tracheomegaly, a condition where the windpipe widens, as a possible side effect.

Previous research indicates that FETO therapy can also reduce the need for ECMO, a machine that assists with breathing and blood circulation, after birth. This suggests that the procedure could help babies breathe better once born.

Overall, FETO therapy has been studied extensively. While it shows promise, awareness of possible risks like tracheomegaly is important. Anyone considering this treatment should discuss it thoroughly with their healthcare provider to understand the potential benefits and risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

FETO therapy is unique because it provides a prenatal intervention for congenital diaphragmatic hernia (CDH) that directly addresses the root cause of the condition. Unlike traditional treatments, which often involve surgery after birth to repair the diaphragm and support lung function, FETO (Fetoscopic Endoluminal Tracheal Occlusion) is performed while the baby is still in the womb. This technique involves placing a tiny balloon in the fetus's trachea to encourage lung growth and development before birth, potentially improving outcomes significantly. Researchers are excited about FETO therapy because it has the potential to enhance lung function and increase survival rates for babies with CDH, offering a proactive rather than reactive approach to managing the condition.

What evidence suggests that FETO therapy might be an effective treatment for congenital diaphragmatic hernia?

Research has shown that Fetoscopic Endoluminal Tracheal Occlusion (FETO) therapy, studied in this trial, might be a promising treatment for severe congenital diaphragmatic hernia (CDH). Previous studies found that FETO can improve survival chances for babies with this condition. Specifically, the TOTAL trials, which studied FETO, reported significant improvements in survival rates for these infants. Additionally, FETO therapy increased the size of the baby's lungs before birth, which is important for better health outcomes after birth. While more research is needed, these findings suggest that FETO could be a helpful option for severe cases of CDH. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for pregnant women over 18 with a severe case of left-sided congenital diaphragmatic hernia in their fetus (O/E LHR < 25%). They must be at 27-29 weeks gestation, have no other lethal fetal anomalies or major heart defects, and agree to stay within 15 minutes of the Midwest Fetal Care Center.

Inclusion Criteria

I am an adult woman pregnant with a baby diagnosed with severe left-sided CDH.

Acceptance of responsibility to stay locally (within 15 minutes) of MWFCC and Children's Minnesota - Minneapolis

My condition does not involve life-threatening anomalies, genetic variants, or abnormal chromosome numbers.

Exclusion Criteria

Short cervix (20 mm or less)

Maternal factors precluding safe fetal surgery

History of natural rubber latex allergy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

FETO Placement Procedure

Placement of the FETO device before gestational age 29 weeks 6 days

1 day

1 visit (in-person)

FETO Removal Procedure

Removal of the FETO device no later than 35 weeks 6 days gestational age

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including routine care in the NICU and monitoring up to 2 years of age

up to 2 years

What Are the Treatments Tested in This Trial?

Interventions

• FETO therapy

Trial Overview The study tests Fetoscopic Endoluminal Tracheal Occlusion (FETO) therapy on fetuses with severe CDH. It aims to increase lung volume before birth, potentially improving survival rates post-birth. The pilot will enroll ten participants to assess feasibility.

How Is the Trial Designed?

Group I: FETO therapy Experimental Treatment 1 Intervention

FETO therapy

FETO therapy is already approved in United States for the following indications:

Approved in United States as FETO for:

• Severe congenital diaphragmatic hernia (CDH)

Who Is Running the Clinical Trial?

Children's Hospitals and Clinics of Minnesota

Lead Sponsor

Trials

67

Recruited

5,022,000+

Allina Health System

Collaborator

Trials

60

Recruited

1,178,000+

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]

Fetoscopic endoluminal tracheal occlusion (FETO) was performed on 21 cases of severe congenital diaphragmatic hernia (CDH), resulting in a postnatal survival rate of 47% for infants with isolated unilateral CDH.

The study found that the increase in the observed/expected lung-to-head ratio (O/E LHR) after the FETO procedure was significantly greater in surviving infants compared to those who did not survive, indicating a potential predictor of survival.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fetoscopic Endoluminal Tracheal Occlusion in Fetuses with Severe Diaphragmatic Hernia: A Three-Year Single-Center Experience. Persico, N., Fabietti, I., Ciralli, F., et al.[2018]

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]

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]

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. 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 ...

3. 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 ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10863657/

Fetoscopic Endoluminal Tracheal Occlusion for Severe, Left ... The use of fetoscopic endoluminal tracheal occlusion in severe left-sided congenital diaphragmatic hernia may improve morbidity but did not ...

5. 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, ...

6. 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.

7. mayoclinic.org mayoclinic.org/medical-professionals/obstetrics-gynecology/news/multisite-study-finds-feto-associated-with-reduced-postbirth-ecmo-for-fetuses-with-cdh/mac-20575537

Multisite study finds FETO associated with reduced ... A North American multisite study of fetoscopic endoluminal tracheal occlusion (FETO) for fetuses with severe, left-sided congenital diaphragmatic hernia (CDH)