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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000041484

Enrollment

Registered

2020-08-21

Start date

2020-04-10

Completion date

Unknown

Last updated

2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute encephalopathy with biphasic seizures and late reduced diffusion or suspected

Interventions

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.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Countries

Japan

Contacts

Public ContactGo Kawano

St Mary's Hospital Paediatrics

Kawano19720625@yahoo.co.jp0942-35-3322

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Sep 19, 2026