Fetoscopic Endoluminal Tracheal Occlusion (FETO)
What is fetoscopic endoluminal tracheal occlusion?
Fetoscopic endoluminal tracheal occlusion (FETO) is a fetal surgery procedure that may improve outcomes in babies with moderate to severe cases of congenital diaphragmatic hernia (CDH).
CDH is a birth defect characterized by the development, very early in gestation, of a hole in the diaphragm, the breathing muscle that separates the chest from the abdomen. As a result, the intestines and other organs in the abdomen can move into the chest and press on the developing lungs. This prevents the lungs from growing and developing normally.
In severe cases, CDH can lead to serious disease and death at birth. For these babies, treatment before birth may allow the lungs to grow enough before birth so these children are capable of surviving and thriving.
As part of a clinical research study approved by the U.S. Food and Drug Administration (FDA), Children’s Hospital of Philadelphia (CHOP) is offering FETO as a treatment option to select fetuses with moderate to severe CDH.
- Determine if the FETO procedure can be performed successfully in unborn babies with moderate to severe CDH
- Show fetal lung growth
- Determine outcomes including infant survival rate and follow-up information
Before determining the best course of treatment for your baby, you will undergo a standard prenatal evaluation at CHOP to find out if you are a candidate for fetal surgery as part of this research study. Your evaluation will include:
- Medical history and physical exam
- Level II ultrasound
- Fetal echocardiogram
- Fetal magnetic resonance imaging (MRI)
- Psychosocial evaluation
(For healthcare professionals: find additional details about referral guidelines.)
What to expect
If you are a candidate for the FETO procedure and decide to pursue fetal surgery, you and your unborn baby will undergo two procedures:
- A balloon will be placed in your unborn baby’s airway. The balloon blocks the baby’s airway and remains in place for a few weeks. Fluid builds and the lungs grow. Bigger lungs may improve survival.
- Several weeks later, the balloon will be removed from your unborn baby’s airway in order for her lungs to mature.
Delivery will be planned in the Garbose Family Special Delivery Unit (SDU).
After your baby is born, she will be stabilized in the Newborn/Infant Intensive Care Unit (N/IICU). Once stabilized, she will undergo surgery to repair the hole in her diaphragm.
While the balloon is in place, the fetal airway is blocked. Unexpected delivery will be life-threatening if the proper systems are not in place to manage your baby’s airway.
As a result, mothers enrolled in this study must remain near our fetal center, under close supervision, from the time of balloon placement through delivery in the SDU and discharge from our N/IICU.
Children who undergo FETO to prenatally treat severe CDH as part of this clinical research study will be followed through 2 years of age and then long-term in the Pulmonary Hypoplasia Program at CHOP.
As part of the clinical research study, you and your child will return to CHOP when the child is 6 months old and again at 12 months and 24 months for routine clinical care visits and research-related developmental evaluations. At all visits the following assessments are performed:
- Overall general surgical evaluation
- Hearing evaluation
- Heart evaluation
- Lung evaluation
- Development evaluation
- Overall medical evaluation
A pediatric chest X-ray is performed at the 12- and 24-month visits.
If you or a woman you know is carrying a fetus with congenital diaphragmatic hernia, please contact the Center for Fetal Diagnosis and Treatment at CHOP at 1-800-468-8376 for more information.
Additional study details and criteria can be found on clinicaltrials.gov.