An interventional study of Long Tail Balloon in Severe Congenital Diaphragmatic Hernia, sponsored by Martin-Luther-Universität Halle-Wittenberg. Status unknown at 1 site in Germany. Open to female participants aged 18 Years to 48 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-02-13.
Sponsored by Martin-Luther-Universität Halle-Wittenberg · Not applicable, Interventional, and Treatment
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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:
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.
86 studies on the registry are indexed under Hernias, Diaphragmatic, Congenital; 39 are open to participants now.
This study's planned enrollment of 20 is below the median of 30 across 62 interventional studies indexed under Hernias, Diaphragmatic, Congenital.
Browse Hernias, Diaphragmatic, Congenital studies →Martin-Luther-Universität Halle-Wittenberg is the lead sponsor of 62 studies on the registry; 4 are open to participants now.
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Exclusion Criteria:
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.
Device: Long Tail Balloon
s. description of experimental Arm
neonatal survival
survival rate
Time frame: 1 year
pulmonary hypoplasia
clinical presence of pulmonary hypoplasia (yes - Grade /no)
Time frame: 1 year
Diaphragmatic Hernia operation
Patch (yes/no)
Time frame: 1 year
necrotizing enterocolitis
yes / no
Time frame: 1 year
neurodevelopmental impairment
(yes, - Grade /no)
Time frame: 1 year
APGAR
APGAR (1st/5th/10th min)
Time frame: during the first 10 min after the delivery
umbilical artery pH
pH measument in the umbilical artery
Time frame: during 10 min after the delivery
weight
weight in (g)
Time frame: 24hour
length
neonatal length in cm
Time frame: 24hour
Duration of O2-Ventilation (day)
Duration of O2-Ventilation (day)
Time frame: 1 year
Plan to share: Yes — All patients: only the Nr. of the patient will be available, diagnosis, diaphragmatic hernia left or right, liver herniation, o/e total volume lung ration (%), gestational age at the Operation (long tail FETO), gestational age of the delivery, PPROM (yes/no), APGAR, art. pH, weight.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: when summary data are published
Data sharing details ↗ · web.uk-halle.de
Started Aug 2017 (actual). Primary completion is estimated for Aug 2020, 36 months after the start.
Of 40 interventional studies with no phase under Hernias, Diaphragmatic, Congenital, half reached primary completion within 108 months of starting (the median), counting those still running; a quarter within 33 and three quarters within 133. This study's planned 36 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.
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Hernias, Diaphragmatic, Congenital →
Martin-Luther-Universität Halle-Wittenberg