What is the mechanism of action of this treatment?

Fetoscopic Endoluminal Tracheal Occlusion (FETO) is a treatment for Congenital Diaphragmatic Hernia (CDH) that involves temporarily blocking the fetal trachea to increase lung volume. This procedure promotes lung growth by trapping lung fluid, which expands the lungs and stimulates their development. This is crucial for CDH patients because the hernia often causes underdeveloped lungs (pulmonary hypoplasia), leading to severe respiratory distress after birth. By enhancing lung growth before birth, FETO aims to improve the chances of survival and reduce the severity of respiratory complications in newborns with CDH.

What side effects are associated with this type of intervention?

Fetoscopic Endoluminal Tracheal Occlusion (FETO) for Congenital Diaphragmatic Hernia (CDH) can lead to side effects such as premature rupture of membranes, preterm labor, and surgical complications like infection or bleeding. There are also risks related to the removal of the tracheal balloon, including airway obstruction or damage. Broadly, CDH treatments, including post-birth surgical repair, may result in infection, respiratory complications, and long-term gastrointestinal issues.

What prior FDA approvals exist?

There are no specific FDA-approved drugs or treatments that directly correlate with the Fetoscopic Endoluminal Tracheal Occlusion (FETO) procedure for Congenital Diaphragmatic Hernia (CDH). FETO is a novel approach aimed at increasing fetal lung volume by temporarily blocking the trachea to promote lung growth. Traditional treatments for CDH primarily involve postnatal surgical repair of the diaphragmatic defect and supportive care, including mechanical ventilation and extracorporeal membrane oxygenation (ECMO) for severe cases. The FETO procedure represents an innovative prenatal intervention currently under investigation to improve outcomes for fetuses diagnosed with severe CDH.

What other types of research exist?

Promising novel alternatives to FETO for treating Congenital Diaphragmatic Hernia (CDH) in 2024 include: 1) Ex utero intrapartum treatment (EXIT) procedure, which allows for partial delivery and immediate surgical intervention while maintaining placental support; 2) Advances in prenatal imaging and diagnostics to better plan postnatal surgical repair; 3) Stem cell therapy and regenerative medicine approaches to enhance lung tissue growth and repair; 4) Improved neonatal intensive care strategies, including optimized ventilation techniques and extracorporeal membrane oxygenation (ECMO) protocols.

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Device

FETO for Diaphragmatic Hernia (FETO Trial)

N/A

Recruiting

Led By Aimen Shaaban, MD

Research Sponsored by Aimen F. Shaaban, MD

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up birth to one year

Awards & highlights

Summary

This trial involves placing a small balloon in the unborn baby's windpipe to help their lungs grow. It targets pregnant women whose babies have a severe condition affecting their diaphragm. The balloon helps the baby's lungs develop by blocking the windpipe.

Who is the study for?

This trial is for pregnant women over 18 with a single pregnancy and severe congenital diaphragmatic hernia in the fetus, showing specific lung underdevelopment. Participants must be willing to follow study procedures, live near the Chicago Institute for Fetal Health, and have no major health issues or conditions that could affect safety or compliance.

What is being tested?

The trial tests Fetoscopic Endoluminal Tracheal Occlusion (FETO) using a detachable balloon and microcatheter on fetuses with severe diaphragmatic hernia. It aims to increase fetal lung volume before birth at Lurie Children's Hospital of Chicago.

What are the potential side effects?

Potential side effects are not explicitly listed but may include risks associated with any surgical procedure such as infection, bleeding, premature labor, or complications related to the devices used.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ birth to one year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~birth to one year

This trial's timeline: 3 weeks for screening, Varies for treatment, and birth to one year 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 Goldballoon Detachable Balloon at gestational age 27 weeks 0 days (27w0d) to 29 weeks 6 days (29w6d)

Number of successful removals of balloon

Secondary study objectives

Change in fetal lung growth

Gestational age at delivery

Infant survival

+6 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: FETO with GOLDBAL2Experimental Treatment1 Intervention

A detachable balloon will be inserted in the fetal airway during the FETO procedure.

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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

Fetoscopic Endoluminal Tracheal Occlusion (FETO) is a treatment for Congenital Diaphragmatic Hernia (CDH) that involves temporarily blocking the fetal trachea to increase lung volume. This procedure promotes lung growth by trapping lung fluid, which expands the lungs and stimulates their development. This is crucial for CDH patients because the hernia often causes underdeveloped lungs (pulmonary hypoplasia), leading to severe respiratory distress after birth. By enhancing lung growth before birth, FETO aims to improve the chances of survival and reduce the severity of respiratory complications in newborns with CDH.

Find a Location

Who is running the clinical trial?

Aimen F. Shaaban, MDLead Sponsor

Aimen Shaaban, MDPrincipal InvestigatorAnn & Robert H Lurie Children's Hospital of Chicago

Media Library

FETO with Goldballoon Detachable Balloon (GOLDBAL2) along with the delivery Microcatheter (BALTACCI-BDPE100) (Device) Clinical Trial Eligibility Overview. Trial Name: NCT05450653 — N/A

Congenital Diaphragmatic Hernia Research Study Groups: FETO with GOLDBAL2

Congenital Diaphragmatic Hernia Clinical Trial 2023: FETO with Goldballoon Detachable Balloon (GOLDBAL2) along with the delivery Microcatheter (BALTACCI-BDPE100) Highlights & Side Effects. Trial Name: NCT05450653 — N/A

FETO with Goldballoon Detachable Balloon (GOLDBAL2) along with the delivery Microcatheter (BALTACCI-BDPE100) (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05450653 — N/A

~3 spots leftby Sep 2025

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