FETO Surgery for Congenital Diaphragmatic Hernia

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by Inna Lobeck

Age: 18 - 65

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Children's Mercy Hospital Kansas City

Disqualifiers: Under 18, Multi-fetal pregnancy, HIV, others

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

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.

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).

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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.

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Eligibility Criteria

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 am pregnant and 18 years or older.

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

Trial Timeline

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

Participant Groups

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.

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)

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Children's Mercy Hospital Kansas City, MO

UnityPoint Health - Meriter Madison, WI

Who Is Running the Clinical Trial?

Children's Mercy Hospital Kansas City Lead Sponsor

NAFTNet FETO Consortium Collaborator

University of Wisconsin, Madison Collaborator

References

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

Prevalence of symptomatic tracheal morbidities after fetoscopic endoluminal tracheal occlusion: a systematic review and meta-analysis. [2023] Fetoscopic endoluminal tracheal occlusion (FETO) has been shown to improve survival of infants with congenital diaphragmatic hernia (CDH). However, there are concerns that FETO may lead to tracheomegaly, tracheomalacia and related complications.

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

Severe diaphragmatic hernia treated by fetal endoscopic tracheal occlusion. [2022] To examine operative and perinatal aspects of fetal endoscopic tracheal occlusion (FETO) in congenital diaphragmatic hernia (CDH).

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

Feasibility and outcomes of fetoscopic endoluminal tracheal occlusion for severe congenital diaphragmatic hernia: A Japanese experience. [2020] To present the feasibility, safety and outcomes of fetoscopic endoluminal tracheal occlusion (FETO) for the treatment of severe congenital diaphragmatic hernia (CDH).

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] Although fetoscopic endoluminal tracheal occlusion (FETO) was recently shown to improve survival in a multicenter, randomized trial of severe congenital diaphragmatic hernia (CDH), morbidity outcomes remain essentially unknown. The purpose of this study was to assess long-term outcomes in children with severe CDH who underwent FETO.

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

Randomized Trial of Fetal Surgery for Moderate Left Diaphragmatic Hernia. [2022] Fetoscopic endoluminal tracheal occlusion (FETO) has been associated with increased postnatal survival among infants with severe pulmonary hypoplasia due to isolated congenital diaphragmatic hernia on the left side, but data are lacking to inform its effects in infants with moderate disease.