FETO Procedure for Congenital Diaphragmatic Hernia
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if Fetoscopic Endoluminal Tracheal Occlusion (FETO) can help babies with Congenital Diaphragmatic Hernia (CDH) survive longer and experience fewer complications later. CDH occurs when the diaphragm doesn't form properly, allowing organs to move into the chest and affect lung development. Participants can choose between FETO surgery or routine care to manage the condition during pregnancy. Pregnant women carrying a single baby diagnosed with CDH, particularly those with the liver pushing into the chest, might be suitable candidates for this trial. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that may improve outcomes for future families facing similar challenges.
Do I have to stop taking my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss your specific medications with the trial team to get a clear answer.
What prior data suggests that the FETO procedure is safe for treating congenital diaphragmatic hernia?
Research has shown that the Fetoscopic Endoluminal Tracheal Occlusion (FETO) procedure is generally well-tolerated. In one study, 16 out of 40 babies who underwent FETO survived until hospital discharge, compared to 6 out of 40 in a group without the procedure. This suggests that FETO might improve survival for babies with congenital diaphragmatic hernia (CDH). Another study found that FETO increased survival rates from 24% to 49% in severe CDH cases.
Safety information indicates that FETO is a viable option for treating severe CDH. However, the procedure involves surgery, which carries risks. Overall, existing research suggests FETO is safe and beneficial for babies with this condition.12345Why are researchers excited about this trial?
Researchers are excited about the Fetoscopic Endoluminal Tracheal Occlusion (FETO) procedure for treating Congenital Diaphragmatic Hernia (CDH) because it offers a novel approach compared to the standard expectant management, which typically involves routine monitoring and surgical intervention after birth. FETO is unique because it involves placing a balloon in the fetus's trachea to temporarily block it, promoting lung growth before birth. This innovative method could improve lung development and increase survival rates in babies with CDH, addressing a critical gap in current prenatal treatment options. By enhancing lung growth in utero, FETO has the potential to reduce the severity of respiratory complications after birth, offering new hope for affected families.
What evidence suggests that the FETO procedure is effective for congenital diaphragmatic hernia?
Research has shown that a procedure called Fetoscopic Endoluminal Tracheal Occlusion (FETO) can assist babies with a severe birth defect known as congenital diaphragmatic hernia (CDH). In this trial, participants in the FETO surgery Intervention Arm will undergo two surgeries: one to place the balloon and another to remove it before delivery. One study found that FETO increased the chances of survival after birth from 24% to 49% compared to routine care without surgery. Another study showed that 91.7% of babies who had FETO survived, compared to 71.4% who received standard care. These results suggest that FETO might improve survival rates for babies with this condition.12467
Who Is on the Research Team?
Erin Perrone, MD
Principal Investigator
University of Michigan
Are You a Good Fit for This Trial?
This trial is for pregnant women carrying a baby diagnosed with left or right-sided congenital diaphragmatic hernia (CDH). Participants must meet specific medical criteria to ensure safety, and certain health conditions may prevent participation.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
FETO Procedure
Participants undergo the FETO procedure, which includes balloon placement and removal surgeries
Follow-up
Participants are monitored for safety and effectiveness after the FETO procedure, including assessments of fetal lung growth and childhood development
Long-term Outcome Assessment
Assessment of long-term outcomes such as childhood growth failure and neurodevelopmental delay
What Are the Treatments Tested in This Trial?
Interventions
- Fetoscopic Endoluminal Tracheal Occlusion (FETO)
Trial Overview
The study tests the FETO procedure, where a small balloon is placed in the unborn baby's airway using special tools. The goal is to see if this helps babies with CDH survive more often and have fewer long-term problems compared to those who do not get the procedure.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Eligible participants that choose the FETO Intervention Arm, will undergo two surgeries, one to place the balloon and a second to remove the balloon before delivery.
Participants choose to undergo the expectant management, or routine care, of carrying a baby with Congenital Diaphragmatic Hernia (CDH). Participants will undergo a comprehensive fetal evaluation at Michigan Medicine's Fetal Diagnosis and Treatment Center (FDTC) to confirm the diagnosis and severity of the CDH. Eligibility will be based on the results of the clinical assessment.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Dr Erin Perrone
Lead Sponsor
Citations
Feasibility, safety, and outcome of fetoscopic endoluminal ...
Our data have shown that FETO represents a viable option for severe type of CDH fetuses with reasonable outcome.
2.
journals.lww.com
journals.lww.com/greenjournal/fulltext/2024/03000/fetoscopic_endoluminal_tracheal_occlusion_for.18.aspxFetoscopic Endoluminal Tracheal Occlusion for Severe,...
Six-month survival in patients with severe left-sided congenital diaphragmatic hernia did not differ significantly between patients who underwent fetoscopic ...
3.
childrenscolorado.org
childrenscolorado.org/advances-answers/recent-articles/fetoscopic-endoluminal-tracheal-occlusion/FETO for Congenital Diaphragmatic Hernia
In a sub-analysis comparing patients with severe cases, 63 underwent FETO and 43 were managed expectantly. Although survival was similar for ...
Neonatal Airway Management and Outcomes Following ...
In cases of severe CDH, FETO was found to be associated with significantly increased postnatal survival rates compared to expectant management, from 24% to 49% ...
5.
ctv.veeva.com
ctv.veeva.com/study/safety-and-efficacy-of-fetoscopic-endoluminal-tracheal-occlusion-feto-in-congenital-diaphragmaticSafety and Efficacy of Fetoscopic Endoluminal Tracheal ...
The purpose of the study is to determine if babies with left or right-sided CDH that undergo the FETO procedure survive more often and have ...
Safety and Efficacy of Fetoscopic Endoluminal Tracheal ...
The purpose of the study is to determine if babies with left or right-sided CDH that undergo the FETO procedure survive more often and have ...
Fetoscopic-Endoluminal-Tracheal-Occlusion-versus- ...
Congenital diaphragmatic hernia (CDH) is a con- genital anomaly that occurs in approximately 1 in. 2,500 births, with left sided defects ...
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