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prenatal diagnosis, genetics, clinical obstetrics
Fetal Endoscopic Tracheal Occlusion (FETO) for Severe Congenital Diaphragmatic Hernia
The purpose of the study is to study the efficacy of fetal endoscopic tracheal occlusion
(FETO) in cases of severe congenital diaphragmatic hernia (CDH). This study will also collect
safety and effectiveness data for the off-label use of the FETO Goldballoon (the balloon that
will be inserted into the fetal trachea), manufactured by Balt medical. The investigators
hope to study the risks and benefits of FETO in cases of severe CDH in an advanced medical
center such as Lucile Packard Children's Hospital (LPCH) Stanford with access to advanced
maternal-fetal medicine, neonatal services, and neonatal ECMO, and pediatric surgery.
Stanford is currently not accepting patients for this trial.
For more information, please contact Imee Datoc, 650-725-5720.
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Renal Anhydramnios Fetal Therapy
Early pregnancy renal anhydramnios or EPRA is a condition where a pregnant woman does not
have any amniotic fluid around her fetus because of a problem with the fetus's kidneys. This
condition is thought to be fatal once the fetus is born because of inadequate lung growth.
The Renal Anhydramnios Fetal Therapy (RAFT) Trial offers eligible pregnant women with a
diagnosis of EPRA an experimental therapy of repeated or serial "amnioinfusions" of fluid
into the womb. An amnioinfusion involves placing a small needle through the pregnant woman's
skin into the womb next to the fetus. Warm sterile fluid with balanced electrolytes and
antibiotics is then slowly infused into amniotic space inside the womb. The aim is to help
the fetus's lungs grow enough so he or she can survive after birth. These amnioinfusions will
be carried out by an expert in fetal interventions at a RAFT center. There is a significant
risk of early rupture of membranes and early delivery in subjects who receive amnioinfusions,
and any potential trial participants will be counseled about these risks before they decide
whether to join the trial. Any eligible patients who, after counseling, elect to terminate
the pregnancy will not be eligible to participate in the trial. All eligible patients who
choose to join the RAFT trial will be able to choose their assignment into one of two arms of
the study: (1) to receive serial amnioinfusions (2) to not receive amnioinfusions but receive
monitoring for the remainder of the pregnancy at the RAFT center. Thus, assignment of
patients to study arm will not be random, but will be decided by the participant. Fetuses who
do survive after birth will require intensive medical management for kidney failure including
placement of a dialysis catheter and dialysis therapy with the eventual need for a kidney
transplant. Treatment for lung disease secondary to abnormal lung development may also be
required. The study will follow babies and their families until non-survival or transplant.
Update: Due to recommendations from the RAFT trial Data and Safety Monitoring Board, the
trial is no longer open to enrollment for pregnancies complicated by bilateral renal agenesis
as of July 19, 2022. Enrollment for patients with pregnancies complicated by other causes of
fetal renal failure remains open.
Gastroschisis Outcomes of Delivery (GOOD) Study
The objective of this study is to investigate the hypothesis that delivery at 35 0/7- 35 6/7
weeks in stable patients with gastroschisis is superior to observation and expectant
management with a goal of delivery at 38 0/7 - 38 6/7 weeks. To test this hypothesis, we will
complete a randomized, prospective, multi-institutional trial across NAFTNet-affiliated
institutions. Patients may be enrolled in the study any time prior to 33 weeks, but will be
randomized at 33 weeks to delivery at 35 weeks or observation with a goal of 38 weeks. The
primary composite outcome will include stillbirth, neonatal death prior to discharge,
respiratory morbidity, and need for parenteral nutrition at 30 days.