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Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
Study Summary
This trial is testing a new procedure to see if it is safe and effective.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I do not have HIV, Hepatitis-B, or Hepatitis-C.My condition involves the left side of my diaphragm being affected with my liver positioned higher.My unborn baby has been diagnosed with additional anomalies or chromosomal abnormalities.My baby has a right-sided or bilateral diaphragmatic hernia, or an isolated left-sided one with specific ultrasound measurements.I have a health condition that prevents me from having surgery during pregnancy.My baby's genetic test results are normal.I have had issues with my cervix opening too early during pregnancy.You have a condition related to blood compatibility issues between a mother and her baby during pregnancy.You are pregnant with only one baby.If you are pregnant, your baby has severe underdevelopment of the lungs before 29 weeks and 6 days of pregnancy.You have had an allergic reaction to natural rubber latex in the past.I have a short cervix or conditions increasing my risk of early labor.The patient meets certain mental and social requirements.You are pregnant with more than one baby.I do not have someone to stay with me during my pregnancy at the hospital.You have placental abnormalities such as previa, abruption, or accrete when you join the study.If the baby's lung size is below a certain level at a certain stage of pregnancy, they may not be eligible.
- 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
Does the current research protocol accept participants aged 30 and over?
"The age requirements for participation in this clinical trial are between 18 and 50 years old."
Are there any current openings in this research project for participants?
"The details available on clinicaltrials.gov show that this particular medical trial is not presently recruiting patients, even though it has been active since 8/1/2022 and was updated most recently on 5/23/2022. However, a plethora of other trials are looking for participants at the moment."
What goals is this research endeavor attempting to accomplish?
"This clinical trial, monitored over a duration of up to 34 weeks gestation, aims to assessing the Gestational Age at Delivery. Other objectives include determining the Number of days of Diaphragmatic Repair via ultrasound imaging and measuring Fetal Lung Growth by way of LHR (Lung area to head circumference Ratio). Lastly, Oxygen dependency grading will be determined for newborns according as assessed by treating physicians."
Who is eligible to take part in this research investigation?
"This clinical trial is recruiting a cohort of 10 participants, aged 18 to 50 years old, affected by Morgagni hernias. Additional requirements include: single pregnancy with normal fetal karyotype; isolated left CDH with the liver elevated and severe pulmonary hypoplasia evidenced via ultrasound (LHR <25% at 180 - 296 weeks); gestational age for FETO procedure between 27-29 weeks if LHR < 25%, or 30-31 weeks if LHR is 25%-30%; psychological assessment confirming eligibility."
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