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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034843
Receipt No. R000039730
Scientific Title Investigation on the relationship between sleep disorder and diverse development of infants
Date of disclosure of the study information 2018/11/22
Last modified on 2018/11/22

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Basic information
Public title Investigation on the relationship between sleep disorder and diverse development of infants
Acronym Investigation on the relationship between sleep disorder and diverse development of infants
Scientific Title Investigation on the relationship between sleep disorder and diverse development of infants
Scientific Title:Acronym Investigation on the relationship between sleep disorder and diverse development of infants
Region
Japan

Condition
Condition Autism spectrum disorder
Classification by specialty
Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the developmental mechanism of autism spectrum disorder (ASD) through integrated analysis of medical and non-medical data of infants with sleep disorder who are known to have some risks for ASD.
Basic objectives2 Others
Basic objectives -Others Investigation of new biomarkers for ASD
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Infant behavior assessment, infant blood and saliva analysis, assessment of infants' autonomic nervous system, and parents interview of their infants' sleep, sense, and motion.
Key secondary outcomes

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
1 months-old <=
Age-upper limit
60 months-old >=
Gender Male and Female
Key inclusion criteria Infants with and without sleep disorder
Key exclusion criteria Infants with neurological disorders, congenital abnormality, congenital heart or metabolic disorders.
The cases of abusing parents, or parents with mental disorders.
The cases that doctor considered not suitable
Target sample size 350

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yukuo Konishi
Organization Doshisha university
Division name Center for baby science
Zip code
Address 4-1-1 Kizugawadai, Kizugawashi, Kyoto-fu
TEL 0774-73-1917
Email ykonishi@mail.doshisha.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yukihisa Minoura
Organization Doshisha university
Division name Center for baby science
Zip code
Address 4-1-1 Kizugawadai, Kizugawashi, Kyoto-fu
TEL 0774-73-1917
Homepage URL
Email minourayukihisa@gmail.com

Sponsor
Institute Center for baby science, Doshisha university
Institute
Department

Funding Source
Organization RIKEN
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Faculty of medicine, Kagawa university
School of medicine, Kurume university
Hyogo prefectural rehabilitation central hospital
Gakkentoshi hospital
Graduate school of letters, Kyoto university
Medical sciences innovation hub program, RIKEN
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 香川大学医学部(香川県)
久留米大学医学部(福岡県)
兵庫県立リハビリテーション中央病院子どもの睡眠と発達医療センター(兵庫県)
学研都市病院小児科(京都府)
京都大学大学院文学研究科(京都府)
理化学研究所医科学イノベーションハブ推進プログラム(東京都、神奈川県)

Other administrative information
Date of disclosure of the study information
2018 Year 11 Month 22 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
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 10 Month 10 Day
Date of IRB
Anticipated trial start date
2018 Year 11 Month 20 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Cytokines, vitamins etc. in blood and saliva, characteristics of sense/motion/behavior/autonomic nervous system etc. are compared between infants with sleep disorders and healthy subjects.

Management information
Registered date
2018 Year 11 Month 09 Day
Last modified on
2018 Year 11 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039730

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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