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FETO for Congenital Diaphragmatic Hernia (FETO Trial)
N/A
Recruiting
Led By Ahmet A Baschat, MD
Research Sponsored by Johns Hopkins University
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
Anatomically and chromosomally normal fetus
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 to 7 weeks
Awards & highlights
FETO Trial Summary
This trial is testing a new prenatal treatment for babies with congenital diaphragmatic hernia (CDH). CDH is a birth defect where the diaphragm, the muscle that separates the chest from the abdomen, doesn't form correctly. This can cause the intestines and other abdominal organs to push up into the chest, and can prevent the lungs from developing properly. CDH can be diagnosed prenatally with ultrasound or MRI, and the severity can be estimated by the size of the lungs. This trial is testing a new treatment called fetoscopic endotracheal occlusion (FETO) where a balloon is placed
Who is the study for?
This trial is for pregnant women over 18 with a single, anatomically and chromosomally normal fetus diagnosed with severe left-sided congenital diaphragmatic hernia (CDH) and an observed to expected lung to head ratio (O/E LHR) under 30%. It's not for those with right-sided or bilateral CDH, other major anomalies, O/E LHR ≥ 30%, latex allergies, preterm labor risks like a short cervix, or maternal health issues that make surgery risky.Check my eligibility
What is being tested?
The trial tests Fetoscopic Endoluminal Tracheal Occlusion (FETO), using the '11540KE' and 'Balt Goldbal 2 balloon', on fetuses with severe CDH. The aim is to improve survival by promoting lung growth before birth. Babies are divided into two groups based on severity: very severe cases (O/E LHR <25%) and less severe cases (O/E LHR between 25% to <30%).See study design
What are the potential side effects?
Potential side effects of FETO may include complications from fetal surgery such as preterm labor or water breaking early. There might also be risks associated with the balloons used in the procedure.
FETO Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a pregnant woman, 18 or older, and can give consent.
Select...
My fetus is normal in development and chromosomes.
Select...
My liver is pushed up due to a hernia on the left side of my diaphragm.
Select...
My baby has a severe lung condition diagnosed before birth.
FETO Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 to 7 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 to 7 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Successful balloon insertion and removal
Secondary outcome measures
Lung
Survival
FETO Trial Design
1Treatment groups
Experimental Treatment
Group I: 11540KE and Balt Goldbal 2 balloonExperimental Treatment1 Intervention
Patients meeting inclusion criteria will receive fetoscopic tracheal occlusion using the fetoscopy sheath 11540 KE and the Balt Goldbal2 detachable balloon.
Participants with an O/E LHR <25% (severe group) will have FETO completed at 27 weeks + 0 days to 29 weeks + 6 days gestation. Balloon removal is 4-5 weeks after that.
Participants with an O/E LHR 25 to <30% (less severe group) will have FETO completed at 30 weeks + 0 days to 31 weeks + 6 days gestation. Balloon removal is 3 - 4 weeks after that.
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Who is running the clinical trial?
Johns Hopkins UniversityLead Sponsor
2,260 Previous Clinical Trials
14,820,745 Total Patients Enrolled
Ahmet A Baschat, MDPrincipal InvestigatorJohns Hopkins University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am at risk of early labor due to a short cervix or uterine issues.I am a pregnant woman, 18 or older, and can give consent.My pregnancy is between 27 and 29 weeks with a specific hormone ratio below 25%.I have a health condition that prevents me from having surgery during pregnancy.I cannot have surgery using a scope due to technical reasons.My diaphragmatic hernia is right-sided, bilateral, or a severe left-sided with specific severity criteria.My fetus is normal in development and chromosomes.My liver is pushed up due to a hernia on the left side of my diaphragm.My baby has a severe lung condition diagnosed before birth.My pregnancy is between 30 and 31 weeks with a specific lung-to-head ratio.I am pregnant and under 18.I am allergic to natural rubber latex.
Research Study Groups:
This trial has the following groups:- Group 1: 11540KE and Balt Goldbal 2 balloon
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the total cohort size for this experiment?
"Affirmative. The information posted on clinicaltrials.gov showcases that this research project is currently seeking participants. It was initially uploaded to the website on August 1st 2015 and last modified on October 5th 2022, with the intention of recruiting 35 people from a single site."
Answered by AI
Is enrollment in this clinical experiment open to the public?
"Affirmative, the online listing on clinicaltrials.gov indicates that this medical research project is currently enrolling subjects. Initially posted on August 1st 2015 and recently updated on October 5th 2022, 35 patients are being recruited across a single site."
Answered by AI
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