FETO for Congenital Diaphragmatic Hernia

(FETO Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Erin Perrone, MD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Dr Erin Perrone

Disqualifiers: Multi-fetal pregnancy, Latex allergy, Preterm labor, others

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

This is a single site pilot trial to assess the feasibility and safety of treating severe CDH with Fetal Endoscopic Tracheal Occlusion with the Goldballoon Detachable Balloon (GOLDBAL2) along with the Delivery Microcatheter (BALTACCI-BDPE100) at Michigan Medicine. The study will enroll pregnant women that meet study criteria. Participants will have placement of FETO between gestational age at 27 weeks plus 0 days and 29 weeks 6 days. The timing for removal of FETO will ideally be between 34 weeks 0 days and 34 weeks and 6 days but ultimately decided by the Fetal Diagnosis and Treatment Center at Michigan Medicine. This study requires that study participants live within 30 miles of the Von Voigtlander Women's Hospital and C.S. Mott Children's Hospital in order to maintain weekly follow up appointments while the balloon is in place and up to delivery. Additionally, there are lifestyle considerations where participants would be unable to carry on normal daily activities including exercise and sexual intercourse, not be able to work the remainder of the pregnancy, as well as have a support person that is available to stay with such as a spouse, friend, partner, parent.

Will I have to stop taking my current medications?

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.

^{1 2 3 4 5}

How is the FETO treatment for congenital diaphragmatic hernia unique?

FETO (Fetal Endoscopic Tracheal Occlusion) is unique because it involves placing a balloon in the fetus's trachea (windpipe) to promote lung growth 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.

^{4 5 6 7 8}

Eligibility Criteria

This trial is for pregnant women with a baby diagnosed with severe Congenital Diaphragmatic Hernia (CDH). Participants must live within 30 miles of the Von Voigtlander Women's Hospital, have support throughout pregnancy, and be willing to follow study procedures without working or engaging in normal activities like exercise.

Inclusion Criteria

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

Willing to reside within 30 minutes of Von Voigtlander Women's Hospital and ability to maintain follow up appointments

Meets psychosocial criteria

Exclusion Criteria

My baby has a diaphragmatic hernia, with specific lung and liver positioning.

Maternal contraindications to elective fetoscopic surgery

Maternal isoimmunization or neonatal alloimmune thrombocytopenia

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 while the balloon is in place

5-7 weeks

Weekly visits (in-person)

Balloon Removal

Removal of the balloon ideally between 34 weeks 0 days and 34 weeks 6 days of gestation

1 week

1 visit (in-person)

Follow-up

Participants are monitored for maternal complications and infant survival up to 180 days after delivery

up to 180 days postpartum

Participant Groups

The trial tests Fetal Endoscopic Tracheal Occlusion (FETO) using a Goldballoon Detachable Balloon and Delivery Microcatheter on babies with CDH. It aims to see if this treatment is safe and doable at Michigan Medicine between 27-29 weeks' gestation.

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:

University of Michigan Ann Arbor, MI

Who Is Running the Clinical Trial?

Dr Erin Perrone Lead Sponsor

References

1. 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).

2. 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.

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. 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.

5. 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.

6. 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).

7. 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.

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.