Fetoscopic Endoluminal Tracheal Occlusion in Severe Left Congenital Diaphragmatic Hernia (NCT02549820) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Fetoscopic Endoluminal Tracheal Occlusion in Severe Left Congenital Diaphragmatic Hernia
United States14 participantsStarted 2015-07
Plain-language summary
CDH is a birth defect characterized by the development, very early in gestation, of a hole in the diaphragm, the breathing muscle that separates the chest from the abdomen. As a result, the intestines and other organs in the abdomen can move into the chest and press on the developing lungs. This prevents the lungs from growing and developing normally.
In severe cases, CDH can lead to serious disease and death at birth. For these babies, treatment before birth may allow the lungs to grow enough before birth so these children are capable of surviving and thriving.
Who can participate
Age range18 Years – 50 Years
SexFEMALE
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Inclusion criteria
✓. Pregnant women age 18 years and older, who are able to consent
✓. Singleton pregnancy
✓. Normal Karyotype or chromosomal microarray with non-pathologic variants
✓. Diagnosis of Isolated Left CDH with liver up
✓. Gestation at enrollment prior to 29 weeks plus 5 days
✓. SEVERE pulmonary hypoplasia with Ultrasound Observed/Expected Lung-to-Head Ratio (O/E LHR) \< 25%
Exclusion criteria
✕. Pregnant women \< 18 years
✕. Maternal contraindication to fetoscopic surgery or severe maternal medical condition in pregnancy
✕. Technical limitations precluding fetoscopic surgery
. 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