The Fetal Care Center is a member of the North American Fetal Therapy Network (NAFTNet) which is a collaboration between almost 50 fetal surgery centers across the US, Canada, and Mexico. Through this, we are well versed in both the proven therapies as well as novel treatments for fetal conditions and can offer enrollment at our center or referral to other centers if the trial is not available here. Enrollment in any research trial is completely voluntary and the decision to participate or not does not impact our willingness to provide care; however, there are some yet unproven therapies that are only offered through research trials. Below are some of the current trials enrolling at the Fetal Care Center.
Gastroschisis Outcomes of Delivery (GOOD) Study
Site PI: Jesse Vrecenak
Gastroschisis is a congenital defect in which a fetus has a failure of abdominal wall closure early in pregnancy that occurs in about 1 in 5000 pregnancies. This leads to the intestines floating in the amniotic fluid during pregnancy and requires surgery to repair the defect after birth. Sometimes, gastroschisis can also be associated with blockages in the bowels which require a more complicated surgery after birth. During pregnancy, gastroschisis can be associated with poor fetal growth and an increased risk of fetal death, so extra surveillance is done in these pregnancies to try to detect or prevent these outcomes. The optimal time to deliver fetuses with gastroschisis is currently unknown and there are pros and cons of early and later delivery. The GOOD study randomly assigns pregnancies with gastroschisis and without other complications to planned delivery at 35 versus 38 weeks of gestation and compares neonatal outcomes based on planned delivery timing. However, regardless of planned delivery timing, if a clear indication for delivery arises, delivery will occur. For more information, please see the trial website.
Renal Anhydramnios Fetal Therapy (RAFT) Trial
Site PI: Kathy Bligard
Early fetal renal failure is a rare but lethal diagnosis. The fetal kidneys normally make urine which is the source almost all of the amniotic fluid. The amniotic fluid is crucial to allow for fetal lung development. Anhydramnios (or no amniotic fluid at all) when seen early in pregnancy does not allow for the lungs to develop normally and after delivery the neonate is never able to get oxygen from the air into their bloodstream to support life. The RAFT trial offers patients an experimental therapy called serial amnioinfusions to replace the amniotic fluid. These procedures are done at least weekly throughout the pregnancy and involve a thin needle placed through the maternal abdomen and into the amniotic sac which is then used to inject the replacement amniotic fluid. Our hope is that these procedures will allow for fetal lung development and that these neonates have a chance of long-term survival. This does not, however, fix that the fetal kidneys do not work so after birth, these neonates require dialysis until they are old enough to receive a kidney transplant. For more information, please see the trial website.
The Study for Pregnant Women Expecting an Ectodermal Dysplasia Affected Boy (EDELIFE)
Site PI: Dorothy Grange
X-linked hypohidrotic ectodermal dysplasia (XLHED) is a rare genetic condition seen in boys. If a pregnant woman is a carrier for this condition, all of her sons have a 50% chance of being affected. XLHED leads to failure of normal sweat gland development and lack of normal hair and teeth development. This can be life-threatening as sweating is our body’s way of regulating our temperature, and boys with XLHED can develop seizures, infections, poor feeding and may require extensive oral surgery. The EDELIFE study is investigating whether prenatal treatment with an investigational medicine that replaces the protein missing in XLHED impacts the life of these boys and is being performed all over the world. This medication is given 3 times during pregnancy and is injected directly into the amniotic cavity through a thin needle so that the fetus can swallow it. The boys are then followed for up to 5 years to see the impact of the medication. For more information, please see the trial website.
Comparison of Methods of Pulmonary Blood Flow Augmentation in Neonates: Shunt Versus Stent (COMPASS)
Site PI: Andrew Glatz
Some fetuses with congenital heart defects require a fetal blood vessel called the ductus arteriosus to remain open after birth to be able to send blood to the lungs and the body. The ductus arteriosus is normal in fetuses but usually closes after delivery. Temporarily, a medication called prostaglandins can be used to keep this vessel open, but some infants require a procedure to allow this vessel to stay open. However, it is unclear what type of procedure is best. In this study, babies needing surgery are randomly assigned to either have a stent or a shunt procedure and their outcomes are compared in the first year of life. For more information, please see the trial website.
Prenatal Heart and Brain Study
Site PI: Cynthia Ortinau
Infants with congenital heart disease (CHD) are known to have differences in brain development compared to infants without CHD which may impact cognition, language, motor and social skills later in childhood. This study aims to investigate if there are changes to brain growth and development in utero in fetuses with CHD and to determine if fetal MRI can be utilized to predict child at highest risk for developmental differences so that early interventions can be offered. For more information, please see the trial website.