FETO for Congenital Diaphragmatic Hernia

(FETO Trial)

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of California, Davis

Disqualifiers: Multi-fetal pregnancy, Preterm labor, HIV, others

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial tests a procedure where a small balloon is placed in the unborn baby's windpipe to help their lungs develop better. It targets pregnant women whose babies have severe lung development issues. The balloon helps the lungs grow by trapping fluid inside them. This procedure has been developed and tested for many years to help unborn babies with severe lung development issues.

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 data supports the effectiveness of the treatment FETO for Congenital Diaphragmatic Hernia?

Research suggests that FETO (fetal endoscopic tracheal occlusion) can improve survival rates and lung development in babies with severe congenital diaphragmatic hernia, although it may lead to complications like preterm delivery. The treatment is considered promising, but further formal trials are needed to fully evaluate its effectiveness.

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

FETO (Fetal Endoscopic Tracheal Occlusion) is unique because it involves placing a balloon in the fetus's trachea (windpipe) to help the lungs grow better before birth, which is not a standard approach for treating congenital diaphragmatic hernia. This method aims to improve lung development and increase survival rates, unlike traditional treatments that focus on managing symptoms after birth.

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Eligibility Criteria

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.

Trial Timeline

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

Participant Groups

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.

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)

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

UC Davis Medical Center Sacramento, CA

Who Is Running the Clinical Trial?

University of California, Davis Lead Sponsor

References

1. Ireland pubmed.ncbi.nlm.nih.gov

Simulation training for urgent postnatal fetal tracheal balloon removal: Two learning methods. [2023] In fetuses with severe congenital diaphragmatic hernia, fetal endoluminal tracheal occlusion (FETO) with balloon increases survival and reduces morbidity. Balloon removal is often scheduled electively. In urgent cases, in-utero removal is impossible and removal immediately after delivery has to occur, posing risk of death from airway obstruction. Medical staff need training in urgent removal. Ideal training method is unclear; thus, we compared the performance of two groups trained by different methods.

2. Germany pubmed.ncbi.nlm.nih.gov

Tracheomegaly: a complication of fetal endoscopic tracheal occlusion in the treatment of congenital diaphragmatic hernia. [2021] Fetal endoscopic tracheal occlusion (FETO) is a promising treatment for severe congenital diaphragmatic hernia, a condition that carries significant morbidity and mortality. It is hypothesised that balloon occlusion of the fetal trachea leads to an improvement in lung growth and development. The major documented complications of FETO to date are related to preterm delivery.

3. Switzerland 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. [2016] To evaluate if fetal endoscopic tracheal occlusion (FETO) for severe congenital diaphragmatic hernia (CDH) using a 1.0-mm fetoscope improves neonatal outcome.

4. 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).

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

Technical aspects of fetal endoscopic tracheal occlusion for congenital diaphragmatic hernia. [2016] In isolated congenital diaphragmatic hernia, prenatal prediction is made based on measurements of lung size and the presence of liver herniation into the thorax. A subset of fetuses likely to die in the postnatal period is eligible for fetal intervention that can promote lung growth. Rather than anatomical repair, this is now attempted by temporary fetal endoscopic tracheal occlusion (FETO). Herein we describe purpose-designed instruments that were developed thanks to a grant from the European Commission. The feasibility and safety of FETO have now been demonstrated in several active fetal surgery programs. The most frequent complication of the procedure is preterm premature rupture of the membranes, which is probably iatrogenic in nature. It does have an impact on gestational age at delivery and complicates balloon removal. FETO is associated with an apparent increase in survival compared with same severity controls, although this needs to be evaluated in a formal trial. The time has come to do so.

6. Germany pubmed.ncbi.nlm.nih.gov

Fetal surgery using fetoscopic endoluminal tracheal occlusion for severe congenital diaphragmatic hernia: a single-center experience. [2023] To provide a comprehensive report of the experience gained in the prenatal treatment of congenital diaphragmatic hernia (CDH) using fetoscopic endoluminal tracheal occlusion (FETO) following its implementation at a newly established specialized fetal medicine center.

7. 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).

8. England pubmed.ncbi.nlm.nih.gov

Effects of tracheal occlusion on the neonatal cardiopulmonary transition in an ovine model of diaphragmatic hernia. [2019] Fetoscopic endoluminal tracheal occlusion (FETO) aims to reverse pulmonary hypoplasia associated with congenital diaphragmatic hernia (CDH) and mitigate the associated respiratory insufficiency and pulmonary hypertension after birth. We aimed to determine whether FETO improves the cardiopulmonary transition at birth in an ovine model of CDH.