What is FETO?
Fetoscopic endoluminal tracheal occlusion, or FETO, is a surgical procedure to treat the most severe cases of congenital diaphragmatic hernia (CDH) that are diagnosed in utero. If you are pregnant and your baby has been diagnosed with CDH, you might be a candidate for the FETO procedure.
CDH occurs when a hole develops in your unborn baby’s diaphragm (the breathing muscle that separates the chest from the abdomen). The opening allows the abdominal organs to push into the baby’s chest and crowd the developing lungs. This can cause the lungs to remain small and underdeveloped. (See Images 1-6.)
CDH can lead to serious disease and can be life-threatening. In the most severe cases, treatment during pregnancy can allow the lungs to develop more fully and can increase the baby’s chance of survival.
What happens during a FETO procedure?
Normally a fetus’s lungs produce fluid that escapes through the trachea (windpipe). Blocking the trachea prevents this fluid from escaping, which can increase pressure in the trachea. Research has shown that building up this tracheal pressure and fluid content can stimulate lung growth. The FETO procedure provides an artificial way to block your baby’s trachea and promote lung development. (In a typically developing fetus, lung growth occurs naturally, so the trachea doesn’t need to be blocked.)
In a FETO procedure, between 27-31 weeks gestation, a small incision is made in the mother’s belly and uterus. An instrument is 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 (occlude) the trachea. The placenta provides oxygen for your baby, so the balloon doesn’t interfere with fetal breathing before birth. Click here to see a video of the balloon inflation.
The balloon remains in your baby’s trachea for 4-6 weeks, until 32-34 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. Once your baby is born, neonatal care will be provided and surgery will be performed to close the hole in the diaphragm.
Who can have the FETO procedure?
FETO is an experimental procedure. It is not an appropriate treatment for all cases of CDH diagnosed in utero. It is only offered in instances of severe CDH where we feel the mother and baby will have the most potential to benefit from the procedure. We conduct thorough diagnostics and review of a mother’s medical history to determine the appropriate treatment for our patients on an individual basis.
To determine if you are a candidate for the FETO procedure, you will have a standard prenatal evaluation at the Cincinnati Fetal Center within Cincinnati Children’s Hospital, which consists of the following:
• An ultrasound
• A fetal MRI
• A fetal echocardiogram to test your baby’s heart function
• A meeting with a nurse, social worker and genetic counselor
• A team meeting with a maternal-fetal medicine specialist (MFM), pediatric surgeon and neonatologist
After your tests are complete, our team of experts meets with you to discuss whether the FETO procedure is appropriate for you, risks to both mom and baby, and survival rates. We also discuss how severe your baby’s condition is, its impact on the remainder of the pregnancy, medical treatments that might be needed immediately following the birth of your child, and long-term prognosis of babies with CDH.
You do not have to choose to have the FETO procedure performed, even if you are a candidate for it.
What can I expect after the procedure?
If you are a candidate for and choose to have the FETO surgery, the procedure will be done at Cincinnati Children’s Hospital. 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 without proper intensive care.
What will happen after my baby is born?
The plan for delivery and afterward is as follows:
• Mother delivers by C-section at Cincinnati Children’s Hospital with ECMO standby.
• Baby is transferred to the Cincinnati Children’s neonatal intensive care unit (NICU).
• Once stabilized, the baby undergoes surgery to repair the hole in the diaphragm.
Length of stay in the NICU depends on the baby’s pulmonary capacity, the recovery from surgery, how early the mother delivers, and any complications related to prematurity.
FETO Research Study Information for Referring Physicians
The Cincinnati Fetal Center has been selected to participate in a clinical research study approved by the U.S. Food and Drug Administration (FDA) to investigate the efficacy of the FETO procedure. The goals of this study are to:
• Confirm that the FETO procedure can be performed successfully for unborn babies with severe CDH
• Show fetal lung growth
• Determine outcomes including infant survival and long-term health
As part of this research study, the child will be followed through 2 years of age and then long-term after that. We will perform routine clinical care visits and research-related evaluations when your child is 6 months, 12 months, and 24 months old. At each of these appointments, we’ll do an overall medical and surgical evaluation, and will assess the child’s hearing, heart, lungs, and developmental milestones.
We are now accepting patients for evaluation as study participants. Inclusion and exclusion criteria for this intervention, at this time, are listed below. As new information becomes available, these criteria are subject to change.
We encourage referring physicians to contact our center if you have a patient you think may be a candidate for FETO intervention.
1. Pregnant women age 18 years and older, who are able to consent
2. Singleton pregnancy
3. Normal fetal karyotype
4. No major cardiac defect
5. Fetal diagnosis of isolated left-sided CDH with liver up
6. Gestation at enrollment prior to 29 weeks plus 5 days if US O/E LHR is <25% OR prior to 31 weeks plus 5 days if US O/E LHR is 25% to <30%
1. Pregnant women < 18 years
2. Maternal contraindication to fetoscopic surgery or severe maternal medical condition in pregnancy
3. Technical limitations precluding fetoscopic surgery
4. Rubber latex allergy
5. Preterm labor, cervix shortened (<15 mm at enrollment or within 24 hours of FETO balloon insertion procedure) or uterine anomaly strongly predisposing to preterm labor, placenta previa
6. Psychosocial ineligibility, precluding consent
7. Diaphragmatic hernia: right sided, bilateral, major associated anomalies, isolated CDH with the O/E LHR ≥ 30%
8. Inability to remain at FETO site during time period of tracheal occlusion, delivery and postnatal care
Learn more about the FETO research study.