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Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia (FETO Trial)
FETO Trial Summary
This trial is testing a new medical procedure to see if it is safe and effective.
FETO Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.FETO Trial Design
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- I do not have HIV, Hepatitis-B, or Hepatitis-C.I am at risk of early labor due to a short cervix or uterine issues.I do not have someone to stay with me during my pregnancy at the hospital.I have had a weak cervix, with or without a stitch.You have a condition that can affect your pregnancy called maternal-fetal Rh isoimmunization, Kell sensitization, or neonatal alloimmune thrombocytopenia.You have a specific type of congenital diaphragmatic hernia (CDH) that affects the right side or both sides, or a left-sided CDH with certain ultrasound measurements.Any additional birth defects or genetic abnormalities found during prenatal testing will mean you cannot participate.I have a health condition that prevents me from having surgery during pregnancy.My baby's genetic test results are normal.You are pregnant with only one baby.If the baby's lung size is less than 25% of what is expected at 27 to 29 weeks of pregnancy, or between 25% and 30% of what is expected at 30 to 31 weeks of pregnancy, based on the mother's last menstrual period and the first ultrasound, they will not be included.You are pregnant with more than one baby.The patient meets mental and emotional well-being requirements.If the baby's lungs are too small based on ultrasound measurements taken before they are 29 weeks old, they will not be able to participate in the study. If the lungs are a little small based on ultrasound measurements taken between 30 to 31 weeks, the baby will not be able to participate in the study.You have had an allergic reaction to latex.You have placental abnormalities known when you join the study.My condition involves a left-sided diaphragmatic hernia with the liver positioned higher than normal.
- Group 1: FETO Group
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
Is enrollment still available to join this investigation?
"According to clinicaltrials.gov, this research project is no longer accepting participants. Initially made available on February 8th 2023, the trial was last updated November 21st 2022. Although not recruiting subjects anymore, there are still 244 other trials that require volunteers for their studies."
Who qualifies for the opportunity to take part in this research project?
"This clinical trial is currently searching for 10 individuals with Morgagni hernias, aged between 18 and 50. Those who wish to participate must meet the following criteria: single pregnancy, isolated left congenital diaphragmatic hernia with liver up, gestational age prior to 29 weeks 6 days (as measured via ultrasound), a lung-to head circumference ratio of less than 25% from 180 - 296 weeks gestation, greater than or equal to 25%, but less than 30% from 300 - 316 weeks gestation; psychosocial fitness as determined by an evaluation team; normal fetal karyotype confirmed through culture results or fluorescence in"
Are there any particular goals this clinical trial seeks to accomplish?
"This clinical trial will assess the Gestational Age at Delivery over a maximum of 34 weeks. Secondary objectives are to quantify the Number of days of ventilator support, neonatal intensive care unit residency and Diaphragmatic Repair experienced by recruited infants."
Are participants over 25 years of age eligible for this research trial?
"This clinical trial is restricted to patients aged 18-50. If a participant does not meet this criteria, there are 30 studies available for those under the age of majority and 204 for senior citizens above 65 years old."
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