UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052509 |
|---|---|
| Receipt number | R000059885 |
| Scientific Title | Relationship between the physiological synchrony and social cognitive development between human infants and their mothers: A longitudinal study |
| Date of disclosure of the study information | 2023/11/01 |
| Last modified on | 2023/10/11 15:06:14 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Relationship between the physiological synchrony and social cognitive development between human infants and their mothers: A longitudinal study
Acronym
Relationship between the physiological synchrony and social cognitive development between human infants and their mothers: A longitudinal study
Scientific Title
Relationship between the physiological synchrony and social cognitive development between human infants and their mothers: A longitudinal study
Scientific Title:Acronym
Relationship between the physiological synchrony and social cognitive development between human infants and their mothers: A longitudinal study
Region
| Japan |
Condition
Condition
Healthy adult and child
Classification by specialty
| Adult | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study examines developmental changes in the relationship between gut microbiota, autonomic nervous system, and social cognitive development in infants and their caregivers (mothers) in Japan.
Specifically, we will clarify how the following associations (1), (2), and (3) change from 8 months to 18 months.
(1) Gut microbiota of mother and child
(2) Individual differences in synchrony and fluctuation patterns between mother and child based on neurophysiological data (autonomic nervous system, hormones) of mother and child during mother-infant interaction.
(3) Psychological characteristics and social cognitive development of caregivers and infants, as assessed by questionnaires and eye tracking data.
Basic objectives2
Others
Basic objectives -Others
We will examine the possibility that physical factors (body composition and motor function) and dietary habits of caregivers are related to the physical and mental development of infants.
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
This study examines developmental changes in the relationship between gut microbiota, autonomic nervous system, and social cognitive development in infants and their caregivers (mothers) in Japan.
Key secondary outcomes
We will examine the relationship between the intestinal microbiota and the following variables in order to identify factors related to the physical and mental development of infants.
1 lifestyle habit (e.g., food habit, sleep schedule, exercise habits)
2 physical characteristics (e.g., allergy, susceptibility to cold viruses)
3 psychological traits of mothers (e.g., stress, depressive tendency)
4 infant behavioral characteristics (e.g., temperament)
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
| 6 | months-old | <= |
Age-upper limit
| 20 | months-old | > |
Gender
Male and Female
Key inclusion criteria
1. firstborn infants and their mothers
2. who live mainly in Japan
3. be able to cooperate in the study at 8 months and 18 months of age, both at the lab and at home
4. adult (over 18 years old) caregivers
Key exclusion criteria
1. caregivers who are in the hospital due to mental or physical illness
2. infants at risk for severe developmental disabilities, such as those with chromosomal abnormalities
3. caregivers who are unable to understand the study or answer the questionnaire in Japanese
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Masako |
| Middle name | |
| Last name | Myowa |
Organization
Kyoto University
Division name
Graduate School of Education
Zip code
606-8501
Address
Yoshida-honmachi, Sakyo-ku, Kyoto 606-8501 Japan
TEL
075-753-3074
myowa.masako.4x@kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Masako |
| Middle name | |
| Last name | Myowa |
Organization
Kyoto University
Division name
Graduate School of Education
Zip code
606-8501
Address
Yoshida-honmachi, Sakyo-ku, Kyoto 606-8501 Japan
TEL
075-753-3074
Homepage URL
http://myowa.educ.kyoto-u.ac.jp/
myowa.masako.4x@kyoto-u.ac.jp
Sponsor or person
Institute
Developmental Science Laboratory, Graduate School of Education, Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
Yoshida-Konoe-cho, Sakyo-ku, Kyoto 606-8501, Japan
Tel
075-753-4680
ethcom@kuhp.kyoto-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
1) 研究対象者自宅
2) 京都大学教育学研究科 明和研究室、発達教育実習室（京都府）
3) 総合研究１号館315-316号室明和研究室赤ちゃんラボ（京都府）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 11 | 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
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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 05 | Month | 22 | Day |
Date of IRB
| 2023 | Year | 05 | Month | 22 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
<study design>
observational study
prospective study
longitudinal study
<method for recruiting participants>
We will recruit research subjects through the Kyoto University Baby Researcher System and cooperating organizations (e.g., nursery schools). This study targets primiparous mother and their infants (8 months old) who read the explanatory leaflet about this study and provide mothers' voluntary written consent for participation in this study.
<measurement item>
1.feces sampling: Once per each caregiver and children
2.autonomic nervous activity by recording heart rate.
3.saliva collection (hormonal analysis)
4.questionnaires
Items about socioeconomic status
Items about both mothers and their children
Items about infant development
Items about mothers
Management information
Registered date
| 2023 | Year | 10 | Month | 16 | Day |
Last modified on
| 2023 | Year | 10 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059885
