Why are we doing this research?
Cincinnati Children’s is conducting a research study, sometimes known as a clinical trial or clinical study, to find out if a research procedure for babies with CDH may help your baby’s lungs to develop better while in the womb. The procedure will involve inserting a small balloon in your baby’s throat to keep more fluid in their lungs. This procedure is called fetoscopic endoluminal tracheal occlusion or FETO.
With CDH, the baby’s organs can push through the hole in his/her diaphragm into their chest and crowd his/her developing lungs. This can cause their lungs to remain small and underdeveloped. This study procedure may help to decrease the damage to your baby’s lungs.
What will happen in the study?
If you are interested in learning more, we would first review your routine prenatal tests to determine if you are eligible for this study.
If you and your baby are a good match for this study, you will be given a consent form that thoroughly explains all of the details and procedures of the study. The study team will review the consent form with you and will be sure that all of your questions are answered. You do not have to choose to have the FETO procedure, even if you are a candidate for it.
If you are a candidate for and choose to have the FETO surgery, the procedure will be performed at Cincinnati Children’s. This procedure would be performed between 27 to 31 weeks gestation. A small incision would be made in your stomach and uterus. An instrument will be guided through the incision and into your baby’s trachea. Through a surgical instrument, a balloon is then inserted into the trachea and inflated with fluid to block the trachea. The placenta provides oxygen for your baby, so the balloon doesn’t interfere with his/her breathing before birth.
The balloon remains in your baby’s trachea for 2 to 6 weeks, until 3 to 34 weeks gestation. You will undergo regular ultrasounds during this time to monitor your baby’s condition. A second procedure is performed to deflate or remove the balloon so your baby’s lungs can continue to mature.
You will need to remain in Cincinnati after the procedure and until your baby is born. This is because your baby’s airway is blocked temporarily, and unexpected delivery could be life threatening to your baby without proper intensive care. Once your baby is born, neonatal care will be provided and surgery will be performed to close the hole in the diaphragm.
You and your baby will be in the study for 24 months following the birth of your baby.