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Procedure

FETO for Congenital Diaphragmatic Hernia

N/A
Recruiting
Led By Timothy Crombleholme, MD
Research Sponsored by Timothy Crombleholme
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
Be older than 18 years old
Must not have
Preterm labor, cervix shortened (<15 mm at enrollment or within 24 hours of FETO balloon insertion procedure) or uterine anomaly strongly predisposing to preterm labor, placenta previa
Maternal contraindication to fetoscopic surgery or severe maternal medical condition in pregnancy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up first 28 days of postnatal life
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to improve survival of babies born with a severe lung condition by restoring lung growth before birth.

Who is the study for?
This trial is for pregnant women aged 18 and older with a single pregnancy, who can consent to treatment. It's not for those under 18, with conditions that make fetoscopic surgery risky or impossible, latex allergy, high risk of preterm labor, placenta previa, certain types of diaphragmatic hernia or major associated anomalies.
What is being tested?
The trial tests Fetoscopic Endoluminal Tracheal Occlusion (FETO) in severe congenital diaphragmatic hernia (CDH). The goal is to improve lung growth before birth to increase the chances of newborn survival.
What are the potential side effects?
Potential side effects may include complications from fetoscopic surgery such as bleeding or infection. There could also be risks related to premature labor and delivery challenges due to the tracheal occlusion.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am at high risk for early labor due to a short cervix or uterine issues.
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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 through a scope due to technical reasons.
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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 cannot stay at the hospital for the duration of my treatment and aftercare.
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I am pregnant and under 18.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~first 28 days of postnatal life
This trial's timeline: 3 weeks for screening, Varies for treatment, and first 28 days of postnatal life for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percent of neonatal survivors at time of discharge
Secondary study objectives
Number of days of Postnatal mechanical ventilator support
Prenatal increase in lung volume

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: Fetoscopic Endoluminal Tracheal Occlusion (FETO)Experimental Treatment1 Intervention
An un-blinded non-randomized single arm pilot study of FETO in fetuses with congenital diaphragmatic hernia (CDH)

Find a Location

Who is running the clinical trial?

Timothy CrombleholmeLead Sponsor
Timothy Crombleholme, MDPrincipal InvestigatorConnecticut Children's Medical Center
1 Previous Clinical Trials
15 Total Patients Enrolled
~10 spots leftby Dec 2028
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