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Trial ID: NCT05461222
A Study of the Effectiveness of Fetal Endoscopic Tracheal Occlusion (FETO) in the Management of Severe Prenatally Diagnosed Congenital Diaphragmatic Hernia (CDH)
- Maternal Age: 18-50
- Singleton gestation
- Gestational age before 29 weeks 6 days
- Severe left or right-sided CDH: For severe left sided CDH observed-to-expected
lung-to- head ratio (o/e LHR) less than 25% between 22 and 29 6/7 weeks' gestation,
liver herniation, MRI lung volumes less than 30% expected based on gestational age
nomograms. For severe right sided CDH o/e LHR less than 30 % between 22 and 29 6/7
weeks' gestation, liver herniation, MRI lung volumes less than 30% expected based on
gestational age nomograms.
- Normal genetic karyotype or microarray testing by amniocentesis or chorionic villus
- Absence of associated fetal structural cardiac anomalies by a dedicated fetal
- Absence of other structural anomalies by ultrasound or MRI
- Appropriate multi-disciplinary counseling performed with maternal-fetal medicine,
neonatology, pediatric surgery, genetics, pediatric otolaryngology (ENT).
- Must be willing to remain near LPCH Stanford (within 30 minutes from the hospital) for
the duration of the balloon placement.
- No maternal and/or fetal contra-indications to fetal surgery such as a bleeding
disorder, poorly controlled diabetes or hypertension, short cervix (measuring < 20mm),
risk for preterm birth etc.
- Planned pregnancy surveillance at LPCH Stanford
- Planned delivery at LPCH Stanford
- Able to provide written consent
- Willingness to comply with all study procedures and availability (meets psychosocial
criteria) for the duration of the study including having a support person
- Contraindications to fetal surgery including poorly controlled hypertension, diabetes
or other maternal medical condition including hematological disorder
- High risk for preterm labor and/or delivery based on either significant history of
preterm birth, short cervix (measuring < 20mm), significant uterine anomaly or other
risk factor, incompetent cervix (requiring cerclage)
- Non-isolated CDH - CDH with additional structural anomalies
- Significant maternal obesity defined as a body mass index (BMI) greater than 40. BMI
is a calculation which includes a person's height and weight
- History of natural rubber latex allergy
- Uterine anomaly such as large or multiple fibroids or mullerian duct abnormality
- Participation in another intervention study that influences maternal and fetal
morbidity and mortality.
- Bilateral CDH, left-sided CDH with O/E LHR >25%, or left-sided CDH with O/E LHR <25%
but liver completely down in abdomen
- Right-sided CDH O/E LHR >30% or right-sided CDH with O/E LHR <30% with liver
completely down in abdomen
- Significant placental abnormalities (abruption, chorioangioma, accreta) known at the
time of enrollment and/or surgery
- Maternal-fetal Rhesus isoimmunization, Kell sensitization or neonatal alloimmune
thrombocytopenia, affecting the current pregnancy.
- Maternal HIV, Hepatitis B with positive surface antigen, Hepatitis C with presence of
virus in maternal blood due to risk of fetal transmission during the procedure
- No safe or feasible fetoscopic approach to balloon placement.
device: Balt "Goldballoon"
School of Medicine
300 Pasteur Drive
Stanford, CA 94305