FETO for Congenital Diaphragmatic Hernia

(FETO Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Ahmet Baschat, MD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Johns Hopkins University

Disqualifiers: Age < 18, Right-sided hernia, others

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

Despite advances in prenatal diagnosis and postnatal therapies, including extracorporeal membrane oxygenation (ECMO), inhaled nitric oxide therapy, and ventilator strategies that minimize ventilator-induced lung injury, morbidity and mortality rates for babies with congenital diaphragmatic hernia (CDH) remain high. The survival relates to the degree of prenatal lung compression and the subsequent impairment of pulmonary function following delivery. Prenatal assessment by ultrasound or magnetic resonance imaging allows to estimate the severity by relating the circumference of the lung contralateral to the hernia to the fetal head circumference lung to head ratio (LHR) and by noting the degree of upward herniation of the liver. Based on the observed to expected lung to head ratio (O/E LHR), prenatally diagnosed congenital diaphragmatic hernia can be prognostically assessed. While overall survival of congenital diaphragmatic hernia is approximately 60%, an O/E LHR \<25% is associated with survival between 11-24%. The rationale for fetal therapy in severe congenital diaphragmatic hernia is to restore adequate lung growth for neonatal survival. Prenatal tracheal occlusion obstructs the normal egress of lung fluid during pulmonary development leading to increased lung tissue stretch, increased cell proliferation, and accelerated lung growth. European colleagues have developed intrauterine endoscopic techniques (fetoscopy) to position and remove endoluminal tracheal balloons in utero (fetoscopic endotracheal occlusion = FETO). Recently, the Belgium group published summary results of FETO showing an improved survival in 175 patients with isolated left CDH from 24% to 49%. We hypothesize that FETO can be performed and may increase survival and decrease morbidity when compared to standard prenatal care for the treatment of severe CDH in the most severe group of fetuses with left CDH (O/E LHR \< 30%). FETO therapy will be considered in two subgroups: those with and O/E LHR \<25% (severe group) and those with an O/E between 25 to \<30% (less severe group).

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 for congenital diaphragmatic hernia?

Research shows that FETO, which involves placing a balloon in the fetal trachea, can improve survival and reduce complications in babies with severe congenital diaphragmatic hernia by helping their lungs grow better before birth.

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Is FETO generally safe for humans?

FETO (Fetoscopic Endoluminal Tracheal Occlusion) has been shown to be feasible and safe in several fetal surgery programs, although it can lead to complications like preterm premature rupture of membranes, which may affect the timing of delivery. The procedure involves a balloon that contains a metallic component, which could pose risks during MRI scans, but these risks have been evaluated for safety.

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

FETO (Fetoscopic Endoluminal Tracheal Occlusion) is unique because it involves placing a balloon in the fetus's trachea (windpipe) to promote lung growth before birth, which is different from traditional surgical repairs done after birth. This approach aims to improve survival rates by enhancing lung development in severe cases of congenital diaphragmatic hernia.

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Eligibility Criteria

This trial is for pregnant women over 18 with a single, anatomically and chromosomally normal fetus diagnosed with severe left-sided congenital diaphragmatic hernia (CDH) and an observed to expected lung to head ratio (O/E LHR) under 30%. It's not for those with right-sided or bilateral CDH, other major anomalies, O/E LHR ≥ 30%, latex allergies, preterm labor risks like a short cervix, or maternal health issues that make surgery risky.

Inclusion Criteria

I am a pregnant woman, 18 or older, and can give consent.

My pregnancy is between 27 and 29 weeks with a specific hormone ratio below 25%.

My fetus is normal in development and chromosomes.

Exclusion Criteria

I am at risk of early labor due to a short cervix or uterine issues.

I have a health condition that prevents me from having surgery during pregnancy.

I cannot have surgery using a scope due to technical reasons.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

Up to 82 days

Intervention

Participants undergo Fetoscopic Endoluminal Tracheal Occlusion (FETO) procedure

Up to 55 days

Weekly visits for ultrasound and monitoring

Delivery and Follow-up

Participants are monitored from delivery until the child reaches 24 months of age

Up to 744 days

Regular follow-up visits including developmental assessments

Participant Groups

The trial tests Fetoscopic Endoluminal Tracheal Occlusion (FETO), using the '11540KE' and 'Balt Goldbal 2 balloon', on fetuses with severe CDH. The aim is to improve survival by promoting lung growth before birth. Babies are divided into two groups based on severity: very severe cases (O/E LHR <25%) and less severe cases (O/E LHR between 25% to <30%).

Group I: 11540KE and Balt Goldbal 2 balloon Experimental Treatment 1 Intervention

Patients meeting inclusion criteria will receive fetoscopic tracheal occlusion using the fetoscopy sheath 11540 KE and the Balt Goldbal2 detachable balloon. Participants with an O/E LHR \<25% (severe group) will have FETO completed at 27 weeks + 0 days to 29 weeks + 6 days gestation. Balloon removal is 4-5 weeks after that. Participants with an O/E LHR 25 to \<30% (less severe group) will have FETO completed at 30 weeks + 0 days to 31 weeks + 6 days gestation. Balloon removal is 3 - 4 weeks after that.

11540KE and Balt Goldbal 2 balloon is already approved in European Union, United States for the following indications:

🇪🇺 Approved in European Union as FETO for:

• Severe congenital diaphragmatic hernia (CDH)

🇺🇸 Approved in United States as FETO for:

• Severe congenital diaphragmatic hernia (CDH)

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Johns Hopkins Center for Fetal Therapy Baltimore, MD

Who Is Running the Clinical Trial?

Johns Hopkins University Lead Sponsor

KARL STORZ Endoscopy-America, Inc. Industry 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. 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).

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

Impact of fetal intervention on postnatal management of congenital diaphragmatic hernia. [2014] We report our experience in the postnatal management of congenital diaphragmatic hernia (CDH) after fetal endoluminal balloon tracheal occlusion (FETO).

4. 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.

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

Single-Center Outcome of Fetoscopic Tracheal Balloon Occlusion for Severe Congenital Diaphragmatic Hernia. [2021] To assess feasibility and maternal and infant outcome after fetoscopic tracheal balloon occlusion in patients with severe congenital diaphragmatic hernia.

6. 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.

7. Switzerland pubmed.ncbi.nlm.nih.gov

Evaluation of Magnetic Resonance Imaging Safety and Imaging Issues Associated with the Occlusion Balloon Used during Fetoscopic Endoluminal Tracheal Occlusion. [2019] Congenital diaphragmatic hernias can be successfully treated by fetoscopic tracheal occlusion (FETO), a minimally invasive procedure that may improve postnatal survival. The endoluminal balloon utilized for FETO contains a metallic component that may pose possible risks for the fetus and mother related to the use of magnetic resonance imaging (MRI). The objective of this study is to evaluate MRI-related imaging and safety issues (magnetic field interactions, heating, and artifacts) for the occlusion balloon used in FETO.

8. 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.