FETO With Long Tail Balloon for a Treatment of Severe CDH (LongTailFETO)
Severe Congenital Diaphragmatic Hernia
About this trial
This is an interventional treatment trial for Severe Congenital Diaphragmatic Hernia focused on measuring CDH, FETO, fetal surgery, long tail FETO
Eligibility Criteria
Inclusion Criteria:
- maternal age of 18-48 years
- severe CDH with MRI measured observed/expected total fetal lung volume (o/e TFLV) < 25% or < 35% in combination with a liver herniation into the thorax.
Exclusion Criteria:
- fetuses with other letal morphological abnormalities
- fetuses with chromosomal abnormalities
- severe maternal illneses
Sites / Locations
- Center of Fetal Surgery, Clinic of Obstetrics and Perinatal Medicine, Martin-Luther-University Halle-WittenbergRecruiting
Arms of the Study
Arm 1
Experimental
Long-Tail-FETO
Fetus with severe CDH and o/e TFLV Ratio of < 25% or < 35% with liver herniation. The Long tail FETO will performed between 26 and 30 weeks of gestation. The MRI control will be perfirmed ar 32-34 weeks of gestation. Long Tail FETO: fetal i.m. application of 0.1 mg/kg Pancuronium, 1 µg/kg Fentanyl® and 0.01 mg/kg atropine. ("Long-Tail" Goldbal 5, 2,5 ml, BALT Extrusion, Montmorency, France). The fetoscope (Karl Storz, Tuttlingen, Germany) with a diameter of 1.3 mm, will be percutaneously inserted through a sheath into the uterus and then into the fetal trachea. The fetoscope will be removed and the balloon will be inserted under 4-D ultrasound guidance into the fetal trachea. The position of the balloon and suture will be visualized using the fetoscopy. The Long tail ballon will be removed by a second FETO after 34 weeks' gestation or bei the fetus itself with or without of the long tail balloon puncture with 22 gauge needle. The EXIT procedure is also possible.