Unique ID issued by UMIN | UMIN000041484 |
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Receipt number | R000047364 |
Scientific Title | Synergetic/additive neuroprotection of remote ischaemic postconditioning to therapeutic hypothermia in pediatric patients with acute encephalopathy with biphasic seizures and late reduced diffusion |
Date of disclosure of the study information | 2020/08/21 |
Last modified on | 2021/08/24 19:03:25 |
The Safety and synergetic/additive neuroprotective effect of remote ischaemic postconditioning to therapeutic hypothermia in pediatric patients with acute encephalopathy with biphasic seizures and late reduced diffusion
The Safety and synergetic/additive neuroprotective effect of remote ischaemic postconditioning to therapeutic hypothermia in pediatric patients with acute encephalopathy with biphasic seizures and late reduced diffusion
Synergetic/additive neuroprotection of remote ischaemic postconditioning to therapeutic hypothermia in pediatric patients with acute encephalopathy with biphasic seizures and late reduced diffusion
Synergetic/additive neuroprotection of remote ischaemic postconditioning to therapeutic hypothermia in pediatric patients with acute encephalopathy with biphasic seizures and late reduced diffusion
Japan |
Acute encephalopathy with biphasic seizures and late reduced diffusion or suspected
Pediatrics |
Others
NO
he aim of this trial is to examine the safety and the synergetic/additive neuroprotective effect of remote ischaemic postconditioning to therapeutic hypothermia in pediatric patients with acute encephalopathy with biphasic seizures and late reduced diffusion compared to the historical prognostic data.
Safety,Efficacy
Confirmatory
Explanatory
Phase II
The prevalence of adverse effects in patients with AESD with RIPoC.
The neurological outcomes at 1, 3,6, 12 months, 2 years and 3 years from disease onset were assessed using the PCPC score, from medical records by two paediatricians for each patient including the results of the neurodevelopment evaluation by the Kyoto Scale of Psychological Development 2001, the Tanaka-Binet Intelligence Test, or the WISC-IV, and for each patient, Vineland Adaptive Behavior Scales second edition.
The association between the MRI findings (distribution of brain lesions on the MRI (hemisphere, bilateral frontal lobe, or others); presence of basal ganglia/thalamus lesions, fractional anisotrophy (FA) in the white matter) and the prognosis at 1, 3,6, 12 months, 2 years and 3 years from disease onset were assessed using the PCPC score, from medical records by two paediatricians for each patient including the results of the neurodevelopment evaluation by the Kyoto Scale of Psychological Development 2001, the Tanaka-Binet Intelligence Test, or the WISC-IV, and for each patient, Vineland Adaptive Behavior Scales second edition among the patients.
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
NO
NO
Institution is not considered as adjustment factor.
NO
No need to know
1
Treatment
Other |
RIPoC (4 cycles of inflation 5 mins and deflation 5 mins) applied on a lower extremity using a blood pressure monitor cuff with 200 mmHg.
1 | months-old | <= |
192 | months-old | > |
Male and Female
Patients diagnosed as having AESD or
strongly suspected judging from clinical symptoms/signs (seizures and consciousness disturbance), brain MRI, and electroencephalogram findings. Patients who are being applied therapeutic hypothermia without high intensity area in the white matter are also included.
Patients who the consent is not gained from their parent/parents or guardians for the study.
Patients with thrombocytopenia (<100,000/uL), coagulation disorders (international normalised ratio of prothrombin time > 1.3 s or activated partial thromboplastin time > 50 s).
Patients with shock, or unstable hemodynamic status with elevated intracranial hypertension symptoms, requiring catecholamine medications or antihypertensive medications
Patients with injuries or skin inflammation on both lower extremities which prevent the application of a blood pressure monitor cuff.
14
1st name | Go |
Middle name | |
Last name | Kawano |
St Mary's Hospital
Paediatrics
830-8543
422 Tsubukuhonmachi, Kurume, Fukuoka 830-8543, Japan
0942-35-3322
Kawano19720625@yahoo.co.jp
1st name | Go |
Middle name | |
Last name | Kawano |
St Mary's Hospital
Paediatrics
830-8543
422 Tsubukuhonmachi, Kurume, Fukuoka 830-8543, Japan
0942-35-3322
Kawano19720625@yahoo.co.jp
Paediatrics, St Mary's Hospital
self funding
Self funding
St Mary's Hospital
422 Tsubukuhonmachi, Kurume, Fukuoka 830-8543, Japan
0942-35-3322
Kawano19720625@yahoo.co.jp
NO
聖マリア病院
2020 | Year | 08 | Month | 21 | Day |
Unpublished
Open public recruiting
2020 | Year | 04 | Month | 10 | Day |
2020 | Year | 04 | Month | 10 | Day |
2020 | Year | 04 | Month | 10 | Day |
2026 | Year | 09 | Month | 30 | Day |
2026 | Year | 09 | Month | 30 | Day |
2026 | Year | 09 | Month | 30 | Day |
2026 | Year | 09 | Month | 30 | Day |
2020 | Year | 08 | Month | 20 | Day |
2021 | Year | 08 | Month | 24 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047364
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