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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up first 28 days of postnatal life

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ first 28 days of postnatal life

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percent of neonatal survivors at time of discharge

Secondary outcome measures

Number of days of Postnatal mechanical ventilator support

Prenatal increase in lung volume

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)

0 / 1Eligibility criteria met

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this clinical investigation still open to enrollees?

"Affirmative. According to clinicaltrials.gov, the trial posted on September 6th 2023 is actively enrolling 15 patients from a single site. It was last updated on September 26th 2023."

Answered by AI

What is the maximum participant capacity for this research undertaking?

"Affirmative. The information hosted on clinicaltrials.gov verifies that this medical investigation, which was published September 6th 2023, is still seeking out participants. Specifically, the study requires 15 test subjects from one site to partake in their research."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Trial of Fetoscopic Endoluminal Tracheal Occlusion (FETO)

Timothy Crombleholme 2023. "Trial of Fetoscopic Endoluminal Tracheal Occlusion (FETO)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06064188.

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