UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000040644
Receipt number R000046389
Scientific Title Prospective survey for acute encephalopathy with biphasic seizures and late reduced diffusion among children with prolonged febrile seizures
Date of disclosure of the study information 2020/07/01
Last modified on 2023/12/06 10:21:43

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Basic information

Public title

Prospective survey for acute encephalopathy among children with prolonged febrile seizures

Acronym

AESD in PFS

Scientific Title

Prospective survey for acute encephalopathy with biphasic seizures and late reduced diffusion among children with prolonged febrile seizures

Scientific Title:Acronym

AESD in PFS

Region

Japan


Condition

Condition

prolonged febrile seizure, acute encephalopathy with biphasic seizures and late reduced diffusion

Classification by specialty

Pediatrics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To clarify the incidence and risk factors of acute encephalopathy with biphasic seizures and late reduced diffusion among pediatric patients with prolonged febrile seizures.

Basic objectives2

Others

Basic objectives -Others

Observational study before intervention

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Incidence of AESD among Incidence of AESD among less than 2 year-old children with prolonged febrile seizures (>40min).

Key secondary outcomes

Comparison of initial condition between less than 2 year-old children with prolonged febrile seizures (>40min) and those with AESD.
Sensitivity and specificity of the AESD predictive score


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


Interventions/Control_2


Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit


Not applicable

Age-upper limit

2 years-old >

Gender

Male and Female

Key inclusion criteria

(1) Patients less than two year-old
(2) Patients with prolonged febrile seizuresof longer than 40min
(3) Patients who had written informed consent from their guardians

Key exclusion criteria

(1) Patients with severe brain edema or coagulopathy
(2) Patients with cerebrospinal leukocytosisof more than 15/microL

Target sample size

200


Research contact person

Name of lead principal investigator

1st name Muneaki
Middle name
Last name Matsuo

Organization

Saga University, Faculty of Medicine

Division name

Department of Pediatrics

Zip code

849-8501

Address

5-1-1 Nabeshima, Saga

TEL

0952242314

Email

matsuo@cc.saga-u.ac.jp


Public contact

Name of contact person

1st name Muneaki
Middle name
Last name Matsuo

Organization

Saga University, Faculty of Medicine

Division name

Department of Pediatrics

Zip code

849-8501

Address

5-1-1 Nabeshima, Saga

TEL

0952242314

Homepage URL


Email

matsuo@cc.saga-u.ac.jp


Sponsor or person

Institute

Saga University, Faculty of Medicine

Institute

Department

Personal name



Funding Source

Organization

Saga University, Faculty of Medicine

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

the institutional review board of Saga University Hospital

Address

5-1-1 Nabeshima, Saga

Tel

0952242314

Email

clinstudycenter@mail.admin.saga-u.ac.jp


Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2020 Year 07 Month 01 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled

125

Results

We conducted a prospective investigation into the occurrence of AESD in children under 2 years of age with febrile status convulsions lasting 40 minutes or longer, and found that 16 (12.8%) of 125 cases had AESD.

Results date posted

2023 Year 12 Month 06 Day

Results Delayed

Delay expected

Results Delay Reason

The analysis of the data would be delay because of delayed collection of the results.

Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events

none

Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Enrolling by invitation

Date of protocol fixation

2020 Year 06 Month 03 Day

Date of IRB

2020 Year 06 Month 30 Day

Anticipated trial start date

2020 Year 07 Month 01 Day

Last follow-up date

2023 Year 03 Month 31 Day

Date of closure to data entry

2023 Year 03 Month 31 Day

Date trial data considered complete

2023 Year 06 Month 30 Day

Date analysis concluded

2023 Year 07 Month 31 Day


Other

Other related information

Information to be collected
(1)Age, gender
(2)Time from fever onset to seizue onset
(3) The duration of the seizure
(4) Pre-existed disorder
(5) Treatment
(6) Hight, Weight
(7) Vital sign
(8) Developmental delay
(9) Rapid viral test result
(10) CBC
(11) TP, Alb,BUN, Cr, UA, CRP, Na, K, Cl, AST, ALT, LD, GGTP, ALP, BS, NH3, Lac, PCT
(12) Blood gas
(13) Zn
(14) Outcome: AESD or not


Management information

Registered date

2020 Year 06 Month 03 Day

Last modified on

2023 Year 12 Month 06 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046389


Research Plan
Registered date File name
2021/06/12 (FIX)研究実施計画書(AESD前方視的調査).docx

Research case data specifications
Registered date File name
2021/06/12 調査票 .xlsx

Research case data
Registered date File name