FETO Surgery for Congenital Diaphragmatic Hernia

Not currently recruiting at 1 trial location

Overseen By Linda Cherney Stafford

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Children's Mercy Hospital Kansas City

Disqualifiers: Under 18, Multi-fetal pregnancy, 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: 7

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new surgical procedure called Fetoscopic Endoluminal Tracheal Occlusion (FETO) to assist babies with severe congenital diaphragmatic hernia (CDH). In this condition, a hole in the diaphragm allows organs to move into the chest, affecting lung development. The study aims to determine if placing a special balloon in the fetus's trachea can improve survival and reduce health issues compared to usual prenatal care. Pregnant individuals with a single baby diagnosed with severe left or right CDH might be suitable candidates, especially if they can stay near Children's Mercy Hospital and have support throughout the 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.

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. Please consult with the trial coordinators for guidance.

What prior data suggests that Fetoscopic Endoluminal Tracheal Occlusion is safe for treating congenital diaphragmatic hernia?

Research has shown that Fetoscopic Endoluminal Tracheal Occlusion (FETO) is a promising treatment for severe congenital diaphragmatic hernia (CDH). In a study of 4,524 CDH patients, 106 received FETO, suggesting it could be a beneficial option with positive outcomes. FETO has improved survival rates by promoting lung growth in affected babies.

Another study examined the safety of FETO and found it to be a practical procedure. While FETO appears promising, discussing potential risks and benefits with a healthcare provider is essential. As this treatment remains under investigation, considering all information is crucial before deciding to join a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Fetoscopic Endoluminal Tracheal Occlusion (FETO) for Congenital Diaphragmatic Hernia (CDH) because it offers a novel approach by temporarily blocking the fetal trachea with a balloon. This method encourages lung growth by trapping fluid in the lungs, which is different from traditional postnatal surgeries that address the defect after birth. Unlike conventional treatments, which often focus on repairing the diaphragm after the baby is born, FETO aims to improve lung development before birth, potentially enhancing outcomes for babies with severe CDH.

What evidence suggests that Fetoscopic Endoluminal Tracheal Occlusion might be an effective treatment for congenital diaphragmatic hernia?

Research shows that a procedure called Fetoscopic Endoluminal Tracheal Occlusion (FETO) can help treat severe congenital diaphragmatic hernia (CDH) in babies. Studies have found that FETO significantly increases survival chances for babies with severe CDH by promoting lung growth before birth. The TOTAL trials, which studied FETO, reported a noticeable improvement in survival rates. In this trial, participants in the Balloon Arm will undergo the FETO procedure, which has shown promising results in improving survival chances for babies diagnosed with this condition. Meanwhile, the No Treatment arm includes patients who choose not to participate in the study. ^{1 2 3 5 6}

Who Is on the Research Team?

Inna Lobeck

Principal Investigator

Physician

Are You a Good Fit for This Trial?

This trial is for individuals with severe left or right Congenital Diaphragmatic Hernia (CDH). Specific eligibility criteria are not provided, but typically participants would need to meet certain health standards and may be excluded based on factors that could interfere with the study or their safety.

Inclusion Criteria

Stated willingness to comply with all study procedures and availability for the duration of the study

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

I have someone to stay with me throughout my pregnancy.

Exclusion Criteria

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

Patient contraindication to fetoscopic surgery or severe medical condition in pregnancy

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Fetoscopic Endoluminal Tracheal Occlusion (FETO) surgery and balloon placement, followed by weekly or biweekly monitoring

7 weeks

Weekly or biweekly visits (in-person)

Balloon Removal

Fetoscopic removal of the balloon occlusion between 34 weeks 0 days and 34 weeks 6 days gestation

1 week

1 visit (in-person)

Delivery

Planned delivery around 39 weeks with standard postnatal care and potential use of EXIT procedure if necessary

1 week

Follow-up

Participants are monitored for safety and effectiveness from birth to 36 months of age

36 months

Visits at birth, 6, 12, 24, and 36 months

What Are the Treatments Tested in This Trial?

Interventions

• Fetoscopic Endoluminal Tracheal Occlusion

Trial Overview The trial is testing the safety and effectiveness of a procedure called Fetoscopic Endoluminal Tracheal Occlusion (FETO) using the BALT GOLDBALL2 Balloon. The goal is to see if this treatment improves survival rates and reduces complications compared to standard care.

How Is the Trial Designed?

Group I: Balloon Arm Experimental Treatment 1 Intervention

Participants who consent to the insertion and the removal of the Balt GOLDBAL2 Balloon.

Group II: No Treatment Active Control 1 Intervention

Patients who have been diagnosed with severe CDH at our site but choose not to participate in the study.

Fetoscopic Endoluminal 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?

Children's Mercy Hospital Kansas City

Lead Sponsor

Trials

261

Recruited

941,000+

NAFTNet FETO Consortium

Collaborator

Trials

1

Recruited

20+

University of Wisconsin, Madison

Collaborator

Trials

1,249

Recruited

3,255,000+

Published Research Related to This Trial

In a trial involving 196 women, fetoscopic endoluminal tracheal occlusion (FETO) did not show a significant improvement in survival rates for infants with moderate congenital diaphragmatic hernia compared to expectant care, with 63% survival in the FETO group versus 50% in the control group (P=0.06).

FETO was associated with higher risks of preterm birth and prelabor rupture of membranes (44% vs. 12% and 64% vs. 22%, respectively), indicating potential safety concerns despite no serious maternal complications reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized Trial of Fetal Surgery for Moderate Left Diaphragmatic Hernia. Deprest, JA., Benachi, A., Gratacos, E., et al.[2022]

In a study of 18 children with severe congenital diaphragmatic hernia (CDH) who underwent fetoscopic endoluminal tracheal occlusion (FETO), long-term survival rates were comparable to a non-FETO group, with 67% surviving at 5 years.

Despite improvements in pulmonary morbidity and gastroesophageal reflux disease, many FETO patients continued to require bronchodilators and feeding tubes, indicating ongoing health challenges even after the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Morbidity in children after fetoscopic endoluminal tracheal occlusion for severe congenital diaphragmatic hernia: Results from a multidisciplinary clinic. Sferra, SR., Nies, MK., Miller, JL., 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]

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]

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

Fetoscopic Endoluminal Tracheal Occlusion-Synergic ... Introduction. Congenital diaphragmatic hernia (CDH) is a relatively rare developmental condition that occurs in about 1 out of every 2500 live births [1].

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35838786/

Fetal endoscopic tracheal occlusion for moderate and ... FETO increases the survival rate in fetuses with moderate and severe CDH, especially in fetuses with severe CDH. However, FETO is associated ...

6. 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; ...