CDH is a birth defect in which the diaphragm, the muscle that helps us breath and separates the chest from the abdomen, does not develop normally on one side. This allows the intestines, stomach, spleen and liver to move into the chest and press on the developing lungs.
In severe cases of CDH, this may lead to death or serious disease at birth. Treatment before birth, by fetoscopic endoluminal tracheal occlusion (FETO), may allow the lungs to grow and develop before birth so these babies can survive.
As part of a clinical research study approved by the U.S. Food and Drug Administration (FDA) and the Institutional Review Board at Medical City Children’s Hospital the Fetal Care Center of Dallas is offering FETO as a treatment option to babies with severe CDH.
- Determine if the FETO procedure can be performed successfully in unborn babies with severe CDH
- Determine if FETO can help the lungs grow
- Determine outcomes including survival and follow up information
- Determine the stress on parents of babies with CDH during FETO
In order to determine the best course of treatment for your baby, you will undergo prenatal evaluation at the Fetal Care Center of Dallas. This evaluation will determine if you are a candidate for FETO as part of a research study. This evaluation includes:
- Medical history and physical examination
- Level II ultrasound
- Fetal echocardiogram
- Fetal magnetic resonance imaging (MRI)
- Psychosocial evaluation
If you are a candidate for the FETO procedure and decide to undergo fetal surgery, you and your baby will undergo two procedures. One to place the tracheal balloon and one to remove the tracheal balloon.
A balloon will be placed in your unborn baby’s windpipe. The balloon blocks the baby’s airway and remains in place for a few weeks. Fluid builds up in the lungs, increasing pressure which stimulates the lungs to grow. Bigger lungs may improve survival.
After several weeks in place, the balloon will be removed from your baby’s airway to allow the lungs to recover and mature.
Delivery will be planned at the Fetal Care Center of Dallas at the Medical City Women’s Pavilion Labor and Delivery.
After delivery, the baby will be stabilized in the NICU at Medical City Children’s Hospital and will undergo repair of the hole in the diaphragm.
While the balloon is in place the baby’s airway is blocked and unexpected delivery can be life-threatening for the baby. Mothers enrolled in the FETO study must remain near the Fetal Care Center of Dallas under close supervision from the time of balloon placement until removal.
Follow up Care
Children who undergo FETO to treat severe CDH as part of this clinical research study will be followed through two years of age and then long term in the Fetal Care Center of Dallas CDH Follow Up Clinic.
As part of the clinical research study you and your child will return to the Fetal Care Center of Dallas at 6, 12, and 24 months for routine evaluations. The evaluations will include overall general medical evaluation, hearing, heart and lung and developmental evaluations.
If you or a woman you know is carrying a baby with CDH, please contact the Fetal Care Center of Dallas for more information at 1-972-566-5600.
Additional study details can be found at www.clinicaltrials.gov.