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Procedure

Fetal Endotracheal Occlusion (FETO) for Congenital Diaphragmatic Hernia

N/A

Waitlist Available

Led By Alireza Shamshirsaz, MD

Research Sponsored by Alireza Shamshirsaz

Eligibility Criteria Checklist

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

Must have

Diagnosis of isolated left CDH with liver up

Pregnant patient 18 and older who is able to consent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years of age

Awards & highlights

Study Summary

This trial aims to see if a procedure called Fetal Endotracheal Occlusion (FETO) can help babies with a severe condition called congenital diaphragmatic hernia (CDH).

Who is the study for?

This trial is for pregnant individuals carrying fetuses with severe congenital diaphragmatic hernia. Participants will be between 27 and nearly 30 weeks pregnant when undergoing the FETO procedure, and must be able to follow through with monitoring until their child turns two years old.Check my eligibility

What is being tested?

The study tests the FETO procedure's ability to promote lung growth in fetuses with CDH before birth and improve survival rates after birth. It involves a small group of 10 participants who will have the device placed and then removed several weeks later.See study design

What are the potential side effects?

Potential side effects are not explicitly listed but may include risks associated with any surgical intervention during pregnancy such as infection, premature labor, or harm to the fetus.

Eligibility Criteria

Inclusion Criteria

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

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My condition involves a left-sided diaphragmatic hernia with liver displacement.

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I am pregnant, over 18, and can give consent.

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My genetic tests for chromosomes 13, 18, 21, X, and Y are normal.

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My baby has severe lung underdevelopment with an O/E LHR less than 25%.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years of age

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years of age

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years of age for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Balloon placement operative time

Balloon removal operative time

Gestational age at delivery

+4 more

Secondary outcome measures

CDH repair type

Fetal lung volume

Infant Neurodevelopment

+14 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Fetal Endotracheal Occlusion (FETO)Experimental Treatment1 Intervention

Participants with severe congenital diaphragmatic hernia will undergo the FETO therapy.

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Alireza ShamshirsazLead Sponsor

Alireza Shamshirsaz, MDPrincipal InvestigatorDirector, Maternal Fetal Care Center

1 Previous Clinical Trials

20 Total Patients Enrolled

Frequently Asked Questions

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

Are there any vacancies available for patients to participate in this trial?

"As per clinicaltrials.gov, the current status of this trial indicates it is not actively enrolling patients. Despite being posted on 3/1/2024 and last updated on 2/26/2024, recruitment for this study is temporarily paused. Nonetheless, there are currently 158 other trials seeking participants at this time."

Answered by AI

What are the anticipated results that researchers hope to achieve from conducting this medical study?

"The main focus of this research, to be assessed around 34 weeks prior to birth, is the manner in which FETO is released. Secondary aims encompass evaluating Infant Neurodevelopment through Bayley-4 assessments, tracking Maternal hospitalization by recording total days post-delivery spent in the hospital, and monitoring instances of Retinopathy of prematurity at grade III or beyond."

Answered by AI

Recent research and studies

PediatricsJournal

Outcomes of Congenital Diaphragmatic Hernia: A Population-based Study in Western Australia

Colvin, Joanne, Carol Bower, Jan E. Dickinson, and Jenni Sokol. 2005. “Outcomes of Congenital Diaphragmatic Hernia: A Population-based Study in Western Australia”. Pediatrics. American Academy of Pediatrics (AAP). doi:10.1542/peds.2004-2845.

Obstetrics & GynecologyJournal

Feasibility and Outcomes of Fetoscopic Tracheal Occlusion for Severe Left Diaphragmatic Hernia

Belfort, Michael A., Oluyinka O. Olutoye, Darrell L. Cass, Olutoyin A. Olutoye, Christopher I. Cassady, Amy R. Mehollin-Ray, Alireza A. Shamshirsaz, et al.. 2017. “Feasibility and Outcomes of Fetoscopic Tracheal Occlusion for Severe Left Diaphragmatic Hernia”. Obstetrics & Gynecology. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/aog.0000000000001749.

Ultrasound in Obstetrics & GynecologyJournal

Fetal Endoscopic Tracheal Occlusion Reduces Pulmonary Hypertension in Severe Congenital Diaphragmatic Hernia

Style, C. C., O. O. Olutoye, M. A. Belfort, N. A. Ayres, S. M. Cruz, P. E. Lau, A. A. Shamshirsaz, et al.. 2019. “Fetal Endoscopic Tracheal Occlusion Reduces Pulmonary Hypertension in Severe Congenital Diaphragmatic Hernia”. Ultrasound in Obstetrics & Gynecology. Wiley. doi:10.1002/uog.20216.

clinicaltrials.govStudy