Study

Safety and Effectiveness of Surgical Treatment for Left and Right Congenital Diaphragmatic Hernia

In this study we want to learn about how safe and how well a treatment called Fetoscopic Endoluminal Tracheal Occlusion works to treat babies that have a condition called right and left Congenital Diaphragmatic Hernia.

Why this Research Matters

Congenital Diaphragmatic Hernia (CDH) occurs when there is a hole in a baby's diaphragm that lets the abdominal organs move into their chest. This stops the baby's lungs from growing as they are supposed to. In this study, we are testing a new way to treat CDH, called Fetoscopic Endoluminal Tracheal Occlusion (FETO). FETO involves surgery to place a small device (like a small balloon) in your baby's windpipe while you are pregnant. Then, before your baby is born, we will do a second procedure to remove the device. The device helps your baby's lungs keep growing during the rest of your pregnancy. If you decide to join this study, you will participate for about 2.5 years. All study visits will take place at Children's Hospital Colorado. If you are interested in this study, you will first have a screening visit with the study doctor to see if the study is a good fit. If you are able to join, we will schedule the FETO surgery to place the device. The surgery will happen at the end of your second trimester. After the device is placed, you will have to stay in the hospital for 1 to 2 days for observation. Then, you will come to weekly study visits where we will do physical exams, ultrasounds, and blood tests to check you and your baby's health. Around the 34th week of your pregnancy, we will do a second procedure to remove the device. After your baby is born, you will not need to come to any extra study visits. However, we will collect information about both you and your baby's health from health records until your baby's second birthday. You will not be paid for being in this study.

Who can Participate

All Ages

You may be able to join this study if you are at least 18 years old and pregnant with a single baby. You may also be able to join this study if your baby has been diagnosed with severe isolated left or right CDH. You must be willing to stay within 30 minutes of Children's Hospital Colorado during the time the device is in your baby's windpipe. If you do not live close to the hospital, we can discuss options to help cover the cost of temporary housing. If you are interested in joining this study, we will review other criteria with you to make sure you qualify.