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Fetal Surgery 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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up first 28 days of postnatal life
Awards & highlights
No Placebo-Only Group

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.
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.
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.

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.
Secondary study objectives
Mechanical Ventilator
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?

Connecticut Children's Medical CenterLead Sponsor
73 Previous Clinical Trials
26,609 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
~4 spots leftby Aug 2028
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