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Tracheal Occlusion Device
FETO for Congenital Diaphragmatic Hernia (FETO Trial)
N/A
Recruiting
Research Sponsored by Children's Hospital Medical Center, Cincinnati
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Maternal age greater than or equal to 18 years
Severe pulmonary hypoplasia with ultrasound O/E LHR <25% at the time of surgery
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
FETO Trial Summary
This trial found that, for fetuses with congenital diaphragmatic hernia, tracheal occlusion increased the chance of being born alive and without major surgery.
Who is the study for?
This trial is for pregnant individuals carrying a single fetus with left congenital diaphragmatic hernia, who have decided against terminating the pregnancy. They must be at least 18 years old, willing to stay in Cincinnati for the pregnancy duration, and meet specific gestational age and fetal health criteria. Exclusions include additional fetal anomalies, maternal infections like HIV or Hepatitis B/C, multi-fetal pregnancy, latex allergy, risk of preterm labor.Check my eligibility
What is being tested?
The trial tests Feto-Endoscopic Tracheal Occlusion (FETO), a procedure approved by FDA to treat fetuses with congenital diaphragmatic hernia. It involves temporarily blocking the fetal trachea to promote lung growth before birth.See study design
What are the potential side effects?
Potential side effects are not explicitly listed but may include complications from fetoscopic surgery such as premature labor or damage to the uterus or fetus. The procedure carries risks typical of surgeries performed during pregnancy.
FETO Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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My unborn baby has a severe lung problem detected by ultrasound.
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My unborn baby has a lung problem detected by ultrasound.
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My genetic tests for chromosome abnormalities are normal.
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My family and I decided against ending the pregnancy before 24 weeks.
FETO Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change lung growth on prenatal imaging
Secondary outcome measures
Change need for ECMO therapy
Change neonatal morbidity
Change pulmonary hypertension
+1 moreFETO Trial Design
1Treatment groups
Experimental Treatment
Group I: Fetal Tracheal OcclusionExperimental Treatment1 Intervention
Fetuses with severe or moderate congenital diaphragmatic hernia will be offered fetal tracheal occlusion to increase lung growth.
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Who is running the clinical trial?
Children's Hospital Medical Center, CincinnatiLead Sponsor
815 Previous Clinical Trials
6,531,551 Total Patients Enrolled
Kurt Schibler, MDStudy ChairCCHMC Oversight Data Safety Monitoring Committee
16 Previous Clinical Trials
15,657 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I am under 18 years old.My condition involves a diaphragmatic hernia on both sides or on the left with specific severity.The baby has been found to have more health problems during ultrasound or other tests.I have a health condition that makes surgery during pregnancy risky.You have known issues with your placenta at the time of signing up.The fetal heart ultrasound shows no problems.You are pregnant with only one baby.My unborn baby has a severe lung problem detected by ultrasound.I am a mother with HIV, Hepatitis B, or Hepatitis C.The mother has a problem with her uterus.My unborn baby has a lung problem detected by ultrasound.The procedure is for babies between 30 weeks and 31 weeks and 6 days of development in the womb.You are less than 29 weeks and 6 days pregnant, or less than 31 weeks and 6 days pregnant in special cases.My genetic tests for chromosome abnormalities are normal.It's not safe or possible for me to have a balloon placed via fetoscopy.I am at high risk for early labor due to a short cervix, uterine anomaly, or placenta previa.Your family meets certain mental and social requirements.You are allergic to rubber latex.I have a weak cervix, with or without a stitch.The procedure is done between 27 weeks and 29 weeks and 6 days of pregnancy.My family and I decided against ending the pregnancy before 24 weeks.My condition involves chromosomal abnormalities.You are pregnant with more than one baby.My condition involves a hernia with liver involvement.
Research Study Groups:
This trial has the following groups:- Group 1: Fetal Tracheal Occlusion
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.
Can individuals join this experiment at present?
"As per the clinicaltrials.gov website, this medical trial is still actively enrolling patients and has been since November 1st 2016. The last update on its progress was made on October 29th 2021."
Answered by AI
Do I meet the qualifications to join this clinical trial?
"This medical trial seeks 10 applicants suffering from Morgagni hernias, aged between 18 to 50. The essential criteria for participation includes: Being less than 32 weeks pregnant at Fetal Endoscopic Tracheal Occlusion (FETO) procedure, moderate pulmonary hypoplasia with low Lung-to-head ratio on ultrasound imaging; isolated Congenital Diaphragmatic Hernia (CDH) with liver residing high in the abdomen; severe pulmonary hypoplasia and a lower lung-to-head ration of 25%; age over 18 years old; singleton pregnancy and normal karyotyping/ fluorescent in situ"
Answered by AI
How many participants are included in this medical trial?
"Correct. Clinicaltrials.gov has information that attests to this trial's ongoing recruitment, which was initiated on November 1st 2016 and recently amended October 29th 2021. The study requires 10 patients at a single centre of care."
Answered by AI
Is it possible for those aged seventy and above to partake in this research?
"The eligibility criteria for this experiment mandates that participants must be aged 18 or older, but not exceed 50 years of age."
Answered by AI
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