Diaphragmatic Hernia Clinical Trial
Official title:
Randomized Clinical Trial in Order to Assess the Effect of Fetoscopic Tracheal Balloon Occlusion on the Postnatal Disease Course in Neonates With Left Congenital Diaphragmatic Hernia - FDH-ECMO/BALLOON-TRIAL
Left diaphragmatic hernia detected during fetal life carries a high risk for postnatal lung
failure due to lung underdevelopment and pulmonary hypertension. In severe cases,
extracorporeal membrane oxygenation (ECMO) is used as a life-saving intensive care means to
enable survival of severely affected infants.
Clinical experience from prospective controlled non-randomized case series with fetoscopic
tracheal balloon occlusion has seen improved survival rates in contrast to untreated
controls.
Therefore, the purpose of this randomized clinical trial in a less severely affected
subgroup of patients is whether by fetoscopic tracheal occlusion, the intensity of postnatal
intensive care therapy might be reduced. Primary outcome measure is the need for postnatal
ECMO therapy.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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