Severe Congenital Diaphragmatic Hernia Clinical Trial
Official title:
The Intrauterine Fetoscopic Tracheal Occlusion (FETO) With Long Tail Balloon for a Treatment of Severe Congenital Diaphragmatic Hernia (CDH)
Congenital diaphragmatic hernia (CDH) has an incidence of 1:2200 to 1:4000 newborns. The
survival rate depends on the extent of the lung hypoplasia and pulmonary hypertension. In
case of an observed / expected total fetal lung volume ratio (o/e TFLV) ratio of 25% or lower
and herniation of the liver in thorax, the postnatal survival is estimated to be 10-25% or
lower. The aim of fetoscopic tracheal balloon occlusion is to positively influence the lung
growth in CDH fetuses avoiding the development of lung hypoplasia.
Some complications after sucsessfull FETO before delivery occur because of technical
difficulties during the extraction of the balloon from the trachea, leading to asphyxia,
worse outcome or neonatal demise. Jani et al. published 10 neonatal deaths from 210 FETO
directly related to difficulties with the removal of the intratracheal balloon. The risk of
emergent balloon removal was published to be very high (39%-56%).
Our new technique exploits the fetal ability to removal the intratracheal balloon which has
been implanted for the treatment of severe CDH before the delivery, avoiding many risks
associated with balloon extraction and a second fetoscopy.
The study will be performed on 20 fetuses with severe CDH. Before the FETO the total fetal
lung volume ratio (o/e TFLV) will be measured by fetal MRI (magnetic . Only CDH fetuses with
24-32 weeks' gestation with o/e TFLV < 25% or the fetuses with o/e TFLV < 35% and liver
herniation will be operated Second fetal MRI should be performed in one week after the FETO.
The balloon will be extracted by the fetus itself before the delivery, after puncture with 22
gauge needle under ultrasound guiding, during second fetoscopy or using the EXIT (ex utero
intrapartum Treatment). Neonatal follow up 12 months.
Congenital diaphragmatic hernia (CDH) has an incidence of 1:2200 to 1:4000 newborns,
depending on whether stillbirths are included or not. 40 % of all CDH cases show associated
malformations and chromosomal abnormalities and/or syndromes take place in 10-20%. The
survival rate depends on the extent of the lung hypoplasia and pulmonary hypertension. Liver
herniation into the thorax, is also a negative predictor of fetal survival. In case of an
observed / expected total fetal lung volume ratio (o/e TFLV) ratio of 25% or lower and
herniation of the liver in thorax, the postnatal survival is estimated to be 10-25% or lower.
The aim of fetoscopic tracheal balloon occlusion is to positively influence the lung growth
in CDH fetuses avoiding the development of lung hypoplasia.
A common complication of fetal surgery is the preterm premature rupture of membranes (PPROM)
leading to preterm delivery. The next problem occurs because of technical difficulties during
the extraction of the balloon from the trachea, leading to asphyxia, worse outcome or
neonatal demise. Jani et al. published 10 neonatal deaths from 210 FETO directly related to
difficulties with the removal of the intratracheal balloon. The risk of emergent balloon
removal was published to be very high (39%-56%).
Our new long tail balloon exploits the fetal ability to removal the intratracheal balloon
which has been implanted for the treatment of severe CDH before the delivery, avoiding many
risks associated with balloon extraction and a second fetoscopy.
The study will be performed on 20 fetuses with severe CDH with total fetal lung volume ratio
(o/e TFLV) < 25% or with o/e TFLV < 35% combined with liver herniation into the thorax. The
lung volume will be estimated by fetal MRI. The selected fetuses with severe CDH at 24-32
weeks' gestation will be operated.
Before the Long tail FETO the 0.1 mg/kg Pancuronium, 1 µg/kg Fentanyl® and 0.01 mg/kg
atropine will be applicated i.m. to the CDH fetus using 22 gauge needle under ultrasound
control. The monofilament 5-0 polypropylene suture of 7 cm will be fixed to the balloon
(Goldbal 5, 2,5 ml, BALT Extrusion, Montmorency, France) and the FETO will be performed. 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 long tail balloon will be inserted under 4-D ultrasound guidance.The
position of the balloon and suture will be controlled by fetoscopy and sonography.
Second fetal MRI should be performed in one week after the FETO. The balloon must be
extracted before the delivery.
Possibilities of the Long tail extraction:
1. The fetus is able to extract the balloon from the trachea after FETO, by pulling the
balloons' long tail, at the end of pregnancy;
2. by fetus itself after balloon puncture with 22 gauge needle under ultrasound guiding;
3. during second fetoscopy;
4. or using the EXIT procedure.
The CDH will be closed with / or without a patch. The follow up examinations will be
performed at 6 and 12 months of age the baby.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| No longer available |
NCT00768703 -
Percutaneous Endoscopic Tracheal Plug/Unplug for CDH (Congenital Diaphragmatic Hernia)
|