FETO Surgery for Congenital Diaphragmatic Hernia

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

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of the study is to determine the infant survival and long-term effects of performing Fetoscopic Endoluminal Tracheal Occlusion (FETO) surgery and removal of the BALT Goldbal2 balloon at Children's Mercy Hospital. We hypothesize that FETO balloon placement may increase survival and decrease morbidity when compared to standard prenatal care for the treatment of severe left or right congenital diaphragmatic hernia (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.

How is the FETO treatment different from other treatments for congenital diaphragmatic hernia?

FETO is a unique treatment for congenital diaphragmatic hernia because it involves a minimally invasive procedure where a balloon is placed in the fetus's trachea (windpipe) to promote lung growth before birth, which is different from traditional surgical approaches that are performed after birth. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment Fetoscopic Endoluminal Tracheal Occlusion (FETO) for Congenital Diaphragmatic Hernia?

Research shows that FETO can improve the survival of infants with severe congenital diaphragmatic hernia (CDH), although there are concerns about potential complications like tracheomegaly (enlarged windpipe) and tracheomalacia (softening of the windpipe). ^{1 2 3 4 5}

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

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]

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]

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]

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]

Citations

1. England pubmed.ncbi.nlm.nih.gov

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

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

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

3. Australia pubmed.ncbi.nlm.nih.gov

Feasibility and outcomes of fetoscopic endoluminal tracheal occlusion for severe congenital diaphragmatic hernia: A Japanese experience. [2020]

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

Morbidity in children after fetoscopic endoluminal tracheal occlusion for severe congenital diaphragmatic hernia: Results from a multidisciplinary clinic. [2023]

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

Randomized Trial of Fetal Surgery for Moderate Left Diaphragmatic Hernia. [2022]