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Device

FETO for Congenital Diaphragmatic Hernia (FETO Trial)

N/A

Recruiting

Led By Ahmet A Baschat, MD

Research Sponsored by Johns Hopkins University

Eligibility Criteria Checklist

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

Must have

Pregnant women age 18 years and older, who are able to consent

Anatomically and chromosomally normal fetus

Must not have

Preterm labor, cervix shortened <15 mm within 24 hours prior to the FETO balloon insertion or uterine anomaly strongly predisposing to preterm labor, placenta previa

Diaphragmatic hernia: right-sided or bilateral, major associated anomalies, isolated left-sided with the O/E LHR ≥ 30%

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 to 7 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new prenatal treatment for babies with congenital diaphragmatic hernia (CDH). CDH is a birth defect where the diaphragm, the muscle that separates the chest from the abdomen, doesn't form correctly. This can cause the intestines and other abdominal organs to push up into the chest, and can prevent the lungs from developing properly. CDH can be diagnosed prenatally with ultrasound or MRI, and the severity can be estimated by the size of the lungs. This trial is testing a new treatment called fetoscopic endotracheal occlusion (FETO) where a balloon is placed

Who is the study for?

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.

What is being tested?

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%).

What are the potential side effects?

Potential side effects of FETO may include complications from fetal surgery such as preterm labor or water breaking early. There might also be risks associated with the balloons used in the procedure.

Eligibility Criteria

Inclusion Criteria

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

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

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My fetus is normal in development and chromosomes.

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My liver is pushed up due to a hernia on the left side of my diaphragm.

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My baby has a severe lung condition diagnosed before birth.

Exclusion Criteria

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

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

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My diaphragmatic hernia is right-sided, bilateral, or a severe left-sided with specific severity criteria.

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

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

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I am pregnant and under 18.

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I am allergic to natural rubber latex.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 to 7 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 to 7 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 to 7 weeks for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Successful balloon insertion and removal

Secondary study objectives

Lung

Survival

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: 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.

0 / 10Eligibility criteria met