FETO for Congenital Diaphragmatic Hernia (FETO Trial)

N/A

Recruiting

Led By Erin Perrone, MD

Research Sponsored by Dr Erin Perrone

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

Awards & highlights

No Placebo-Only Group

Summary

This trial is to test the feasibility and safety of a new treatment for severe CDH. It will enroll pregnant women who meet the criteria and who live close to the hospital. There are some lifestyle considerations that the participants must be aware of.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Specific side effects are not listed, but as it involves fetal surgery, potential risks may include preterm labor, membrane rupture, or complications related to the procedure. Close monitoring will occur due to these possible risks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 27w0d - 29w6d

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~27w0d - 29w6d

This trial's timeline: 3 weeks for screening, Varies for treatment, and 27w0d - 29w6d 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

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