35 Participants Needed

FETO for Congenital Diaphragmatic Hernia

(FETO Trial)

AA
JL
Overseen ByJena L Miller, MD
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: Johns Hopkins University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 2 JurisdictionsThis treatment is already approved in other countries

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.12345

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.12367

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.12468

Research Team

AA

Ahmet Baschat, MD

Principal Investigator

Johns Hopkins University

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.
See 4 more

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.
See 3 more

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

Treatment Details

Interventions

  • 11540KE and Balt Goldbal 2 balloon
Trial Overview 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%).
Participant Groups
1Treatment groups
Experimental Treatment
Group I: 11540KE and Balt Goldbal 2 balloonExperimental Treatment1 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

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials
2,366
Recruited
15,160,000+

KARL STORZ Endoscopy-America, Inc.

Industry Sponsor

Trials
13
Recruited
21,500+

Findings from Research

In a study involving 24 medical students, those trained through in-person lectures were significantly faster at setting up instruments for balloon removal in fetal endoluminal tracheal occlusion (FETO) compared to those trained via online video (62 seconds vs 81 seconds).
However, both training methods showed no significant difference in the time taken to locate and intubate the balloon in the trachea, indicating that while in-person training may enhance setup speed, both methods are equally effective for the critical task of balloon removal.
Simulation training for urgent postnatal fetal tracheal balloon removal: Two learning methods.Lehoczky, L., Corroenne, R., Espinoza, J., et al.[2023]
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.
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 19 fetuses diagnosed with congenital diaphragmatic hernia (CDH), those who underwent fetal endoluminal balloon tracheal occlusion (FETO) had postnatal outcomes comparable to those who were not prenatally studied, suggesting that FETO can be a viable intervention even for cases with poor prognosis.
Among the 12 babies born after FETO, while some experienced significant complications requiring advanced ventilation support, the overall survival and recovery rates were promising, with no postoperative mortality reported.
Impact of fetal intervention on postnatal management of congenital diaphragmatic hernia.Saura, L., Castañón, M., Prat, J., et al.[2014]

References

Simulation training for urgent postnatal fetal tracheal balloon removal: Two learning methods. [2023]
Feasibility and outcomes of fetoscopic endoluminal tracheal occlusion for severe congenital diaphragmatic hernia: A Japanese experience. [2020]
Impact of fetal intervention on postnatal management of congenital diaphragmatic hernia. [2014]
Tracheomegaly: a complication of fetal endoscopic tracheal occlusion in the treatment of congenital diaphragmatic hernia. [2021]
Single-Center Outcome of Fetoscopic Tracheal Balloon Occlusion for Severe Congenital Diaphragmatic Hernia. [2021]
Technical aspects of fetal endoscopic tracheal occlusion for congenital diaphragmatic hernia. [2016]
Evaluation of Magnetic Resonance Imaging Safety and Imaging Issues Associated with the Occlusion Balloon Used during Fetoscopic Endoluminal Tracheal Occlusion. [2019]
Fetal surgery using fetoscopic endoluminal tracheal occlusion for severe congenital diaphragmatic hernia: a single-center experience. [2023]