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Fetoscopic Endoluminal Tracheal Occlusion (FETO) for Congenital Diaphragmatic Hernia (FETO Trial)

N/A
Recruiting
Led By Timothy Crombleholme, MD
Research Sponsored by Connecticut Children's Medical Center
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
Fetal Diagnosis of Isolated Left CDH with liver up
Timeline
Screening 3 weeks
Treatment Varies
Follow Up first 28 days of postnatal life
Awards & highlights

FETO Trial Summary

This trial is testing if a new fetal therapy can help babies with a severe birth defect called Congenital Diaphragmatic Hernia (CDH) survive.

Who is the study for?
This trial is for pregnant women aged 18 or older with a single pregnancy and a fetus diagnosed with severe left-sided Congenital Diaphragmatic Hernia (CDH) where the liver has moved up into the chest. The baby must have significant lung underdevelopment, confirmed by ultrasound before 29 weeks + 6 days of gestation, and a normal karyotype.Check my eligibility
What is being tested?
The trial is testing Fetoscopic Endoluminal Tracheal Occlusion (FETO), which is a prenatal surgery aiming to improve lung growth in fetuses with severe CDH by temporarily blocking their trachea.See study design
What are the potential side effects?
Potential side effects may include preterm labor, rupture of membranes, or complications related to the procedure such as infection or injury to the fetus. Long-term outcomes for both mother and child are also being studied.

FETO Trial 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 unborn baby has been diagnosed with a left-sided CDH and the liver is positioned upwards.
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My unborn baby has a normal chromosome count.

FETO Trial 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

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
Mechanical Ventilator
Prenatal increase in lung volume

FETO 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?

Connecticut Children's Medical CenterLead Sponsor
71 Previous Clinical Trials
31,499 Total Patients Enrolled
Medical City Children's HospitalLead Sponsor
1 Previous Clinical Trials
12 Total Patients Enrolled
Timothy Crombleholme, MDPrincipal InvestigatorMedical City Children's Hospital
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.

How many participants have joined this experiment thus far?

"Correct. Evident from clinicaltrials.gov, this medical trial is actively looking for individuals to participate. The first posting was on September 1st 2015 and the most recent update was on February 18th 2020. 15 people are required at one site location for this study."

Answered by AI

Are there any remaining slots available for participants in this experiment?

"Per the information posted to clinicaltrials.gov, this trial is actively enrolling participants and has been since September 1st 2015 with a most recent update on February 18th 2020."

Answered by AI
~5 spots leftby Aug 2028