What is the mechanism of action of this treatment?

Fetal Endoscopic Tracheal Occlusion (FETO) is a procedure used to treat severe Congenital Diaphragmatic Hernia (CDH) by occluding the fetal trachea with a detachable balloon. This occlusion prevents the escape of lung fluid, thereby increasing intrapulmonary pressure and promoting lung growth and development. This is crucial for CDH patients because the herniation of abdominal organs into the chest cavity impairs lung development, leading to pulmonary hypoplasia and respiratory distress after birth. By enhancing lung growth before birth, FETO aims to improve postnatal respiratory function and overall outcomes for infants with severe CDH.

What side effects are associated with this type of intervention?

Common treatments for Congenital Diaphragmatic Hernia (CDH) include surgical repair after birth and prenatal interventions like Fetal Endoscopic Tracheal Occlusion (FETO). Known side effects of FETO include preterm premature rupture of membranes (PPROM), preterm birth, and potential complications related to the balloon placement and removal, such as tracheal injury or occlusion failure. Postnatal surgical repair can lead to complications like infection, recurrence of the hernia, and long-term issues such as pulmonary hypertension and gastrointestinal problems. These treatments aim to improve lung development and overall survival but come with significant risks that need careful consideration.

What prior FDA approvals exist?

There is no specific mention of prior FDA approvals or related drugs for the treatment of Congenital Diaphragmatic Hernia (CDH) in the provided context. The Fetal Endoscopic Tracheal Occlusion (FETO) technique, which involves occlusion of the fetal trachea to promote lung growth, is currently being studied in a pilot trial. This suggests that FETO is still under investigation and has not yet received FDA approval. Broadly, treatments for CDH often involve surgical repair post-birth, and supportive measures to manage pulmonary hypoplasia and hypertension.

What other types of research exist?

Promising novel alternatives to Fetal Endoscopic Tracheal Occlusion (FETO) for treating Congenital Diaphragmatic Hernia (CDH) in 2024 include: 1) Ex utero intrapartum treatment (EXIT) procedure, which allows for partial delivery of the fetus while maintaining placental support to secure the airway and perform necessary surgical interventions. 2) Advances in fetal gene therapy and stem cell therapy aimed at promoting lung growth and repair. 3) Improved prenatal imaging and diagnostic techniques to better plan and execute minimally invasive fetal surgeries. These alternatives are being explored for their potential to improve outcomes and reduce risks associated with traditional FETO procedures.

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Procedure

FETO for Congenital Diaphragmatic Hernia (FETO Trial)

N/A

Recruiting

Research Sponsored by University of California, Davis

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Fetal CDH (left or right) with severe pulmonary hypoplasia, defined as o/e LHR <25% with liver up

No pathogenic variants on microarray or pathologic findings on karyotype

Must not have

Additional fetal or genetic abnormalities that would impact care after delivery or be known to have an impact on outcome

Maternal HIV, Hepatitis B with positive surface antigen, Hepatitis C with presence of virus in maternal blood due to risk of fetal transmission during the procedure

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline (before balloon placement), immediately prior to balloon retrieval

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include complications from the fetoscopic surgery such as preterm labor or damage to the uterus or fetus. There might also be risks associated with living under restricted conditions affecting mental well-being.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My unborn baby has severe lung issues due to CDH, with a very low lung-to-head ratio.

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My genetic tests did not show any harmful changes.

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I am pregnant and 18 years or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My baby has been diagnosed with a condition that could affect their health after birth.

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I do not have HIV, Hepatitis B, or Hepatitis C.

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

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I have known significant issues with my placenta.

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I am unable to give consent for myself.

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It's not safe or possible for me to have a balloon placed via fetoscopy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 27 weeks 0 days to 29 weeks 6 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~27 weeks 0 days to 29 weeks 6 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 27 weeks 0 days to 29 weeks 6 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of successful placements of the Goldballoon Detachable Balloon (GOLDBAL2) at gestational age 27 weeks zero days (27w0d) to 29 weeks and 6 days (29w6d) gestation.

Number of successful retrievals of the GOLDBAL2

Secondary study objectives

Change in fetal lung growth

Change in observed to expected total fetal lung to head ratios (o/e TFLV) on prenatal magnetic resonance imaging (MRI)

Number of maternal complications

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: FETO with GOLDBAL2Experimental Treatment1 Intervention

A balloon will be placed in the airway of the fetus during the FETO procedure.

0 / 9Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Fetal Endoscopic Tracheal Occlusion (FETO) is a procedure used to treat severe Congenital Diaphragmatic Hernia (CDH) by occluding the fetal trachea with a detachable balloon. This occlusion prevents the escape of lung fluid, thereby increasing intrapulmonary pressure and promoting lung growth and development. This is crucial for CDH patients because the herniation of abdominal organs into the chest cavity impairs lung development, leading to pulmonary hypoplasia and respiratory distress after birth. By enhancing lung growth before birth, FETO aims to improve postnatal respiratory function and overall outcomes for infants with severe CDH.