Unique ID issued by UMIN | UMIN000012395 |
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Receipt number | R000014493 |
Scientific Title | Clinical Trial of Fetal Endotracheal Occlusion in fetuses with left sided isolated congenital diaphragmatic hernia |
Date of disclosure of the study information | 2013/11/25 |
Last modified on | 2013/11/25 10:59:34 |
Clinical Trial of Fetal Endotracheal Occlusion in fetuses with left sided isolated congenital diaphragmatic hernia
Clinical trial of FETO
Clinical Trial of Fetal Endotracheal Occlusion in fetuses with left sided isolated congenital diaphragmatic hernia
Clinical trial of FETO
Japan |
Fetal congenital diaphragmatic hernia
Obstetrics and Gynecology | Pediatrics |
Others
NO
This trial will test whether Fetal Endotracheal Occlusion (FETO) can be performed safely in fetuses with left sided isolated congenital diaphragmatic hernia without any serious maternal side effects and will test survival till 90 postnatal days and will test survival rate till 90 postnatal days after FETO.
Safety
Confirmatory
Pragmatic
Not applicable
1) Complete FETO procedures without serious maternal side effects
2) survival till 90 postnatal days
1)Developmental milestones at 6 months after birth
2)Neurodevelopmental milestones at 6 months after birth
3)Adverse effects during FETO procedures
4)Unfixed balloon during and after FETO procedures
5)Lung size after FETO
6)Liver position after FETO
7)Stomach position after FETO
8)Preterm delivery after FETO
9)Intra-uterine fetal demise after FETO
10)Survival after FETO
11)Discharge without any serious complications
12)Number of days in neonatal intensive care unit after birth
13)Number of days of ventilatory support
14)Number of days of NO treatment
15)Complete surgery
16)Any other additional side effects
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Maneuver |
A thin walled flexible Teflon cannula (3.3 mm; Performa, Cook, Strombeek Bever, Belgium), loaded with a pyramidal trocar (11650TG, Karl Storz, Germany) should be inserted into the amniotic cavity towards the fetal mouth. The trocar should then be withdrawn and fetoscopic instruments inserted. These include at present a slightly bent 10 Fr sheath loaded with a 1.3 mm fiber endoscope (Karl Storz). The sheath allows insertion of the balloon occlusion system, consisting of a catheter loaded with a detachable latex balloon. It further has a side connector for amnio-infusion with Hartmann's solution heated to body temperature, for improving visualization and assist in dilatation of the vocal cords on entry of the trachea. The endoscope should be introduced into the fetal mouth, following the tongue and palate, uvula, epiglottis and vocal cords as landmarks. Once inside the trachea the carina should be identified to position and deliver the balloon between carina and vocal cords. The balloon should then be inflated with isotonic fluid (Goldball 2; Balt, Paris, France).
Balloon retrieval should be planned at between 34+0 and 34+6 weeks. The options are ultrasound guided puncture and fetoscopic retrieval.
16 | years-old | <= |
45 | years-old | > |
Female
1) Between 27 and 31 weeks of gestation
2) Pregnant woman who is between 16 to 45 years old
3) Diagnosed as singleton with left sided isolated CDH
4) Diagnosed as left sided CDH with Liver up in the chest cavity and Stomach mainly in the right chest cavity (Grade 3 of Kitano classification)
5)O/E LHR < 45%
6) No other presence of fetal anomaies
7) No sign of pregnancy induced hypertension
8) No genital bleeding
9) No premature rupture of membrane
10) Greater than or equal to 20 mm of cervical length
11) Agreement of patient and her partner to follow the protocol
1) Pregnant woman needs treatment for infectious disease.
2) Presence of HIV antibody, HCV antibody, or HBe antigen in pregnant women
3) Pregnant woman needs treatment for psychological problems
4) American Society of Anesthesiology (ASA) Physical Status Classification: Class 3, 4, 5, or 6
10
1st name | |
Middle name | |
Last name | Haruhiko Sago MD PhD |
National Center for Child Health and Development
Department of Maternal-Fetal and Neonatal Medicine
2-10-1 Okura, Setagaya-ku, Tokyo 157-8535, Japan
03-3416-0181
sagou-h@ncchd.go.jp
1st name | |
Middle name | |
Last name | Seiji Wada MD PhD |
National Center for Child Health and Development
Department of Fetal Therapy
2-10-1 Okura, Setagaya-ku, Tokyo 157-8535, Japan
03-3416-0181
wada-s@ncchd.go.jp
Japan Fetal Therapy Group (Fetus Japan)
Ministry of Health, Labour and Welfare
Japan
NO
国立成育医療研究センター
2013 | Year | 11 | Month | 25 | Day |
Unpublished
Open public recruiting
2013 | Year | 10 | Month | 01 | Day |
2013 | Year | 11 | Month | 25 | Day |
2016 | Year | 09 | Month | 30 | Day |
2013 | Year | 11 | Month | 25 | Day |
2013 | Year | 11 | Month | 25 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014493
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