UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033662 |
|---|---|
| Receipt number | R000038377 |
| Scientific Title | A study on the development of infant -1 |
| Date of disclosure of the study information | 2018/08/20 |
| Last modified on | 2026/04/10 09:19:19 |
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Basic information
Public title
A study on the development of infant -1
Acronym
A study on the development of infant -1
Scientific Title
A study on the development of infant -1
Scientific Title:Acronym
A study on the development of infant -1
Region
| Japan |
Condition
Condition
Healthy infants and Healthy caregivers
Classification by specialty
| Not applicable | Adult | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Understanding the development of infant
Basic objectives2
Others
Basic objectives -Others
Observational Study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Measurement of infant's development
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
| 4 | months-old | <= |
Age-upper limit
| 6 | months-old | >= |
Gender
Male and Female
Key inclusion criteria
(infant)
-Healthy infants
(infant's caregivers)
-Healthy females
Key exclusion criteria
-Infant with chronic sickness.
-Infant with infectious disease.
-Caregiver who can't understand,read and write Japanese.
-Infant and its caregiver who are judged as unsuitable participant by investigators.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Satoshi Haramizu |
Organization
Kao Corporation
Division name
Kansei Science Research
Zip code
Address
2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, Japan
TEL
+81-3-5630-9889
haramizu.satoshi@kao.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Satoshi Haramizu |
Organization
Kao Corporation
Division name
Kansei Science Research
Zip code
Address
2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, Japan
TEL
+81-3-5630-9889
Homepage URL
haramizu.satoshi@kao.com
Sponsor or person
Institute
Kao Corporation
Institute
Department
Personal name
Funding Source
Organization
Kao Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Ritsumeikan university
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
立命館大学（大阪いばらきキャンパス）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 08 | Month | 20 | Day |
Related information
URL releasing protocol
https://www.jstage.jst.go.jp/article/pacjpa/83/0/83_3C-076/_pdf/-char/ja
Publication of results
Unpublished
Result
URL related to results and publications
https://www.jstage.jst.go.jp/article/pacjpa/83/0/83_3C-076/_pdf/-char/ja
Number of participants that the trial has enrolled
46
Results
We observed mother-infant toy play and diaper changing, analyzing facial affect, gaze, and maternal speech to examine whether maternal smiling relates to infants' socio-emotional development. Smiling frequency was not associated with social development scores, but mothers who smiled more used more cognitively supportive talk. Infants whose mothers talked more during diaper changes showed higher social scores, suggesting the value of dialogue even in daily care.
Results date posted
| 2026 | Year | 04 | Month | 10 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Mother-infant dyads were enrolled. Infants were firstborn children and were approximately 5 months of age at the time of observation.
Participant flow
Families attending the 4-month health check-up at the Ibaraki City Child Health Center (Osaka, Japan) were approached, and recruitment flyers describing the study were distributed. Written informed consent was obtained from caregivers. When infants reached 5 months of age, participating dyads were invited to visit the laboratory at Ritsumeikan University, Ibaraki Campus, where study procedures were conducted.
Adverse events
None
Outcome measures
Trained raters coded maternal and infant facial expressions and scored items from the Interaction Rating Scale (IRS) as indices of dyadic interaction. Maternal parenting stress was assessed using the Parenting Stress Index (PSI).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 06 | Month | 27 | Day |
Date of IRB
| 2018 | Year | 06 | Month | 27 | Day |
Anticipated trial start date
| 2018 | Year | 08 | Month | 20 | Day |
Last follow-up date
| 2019 | Year | 05 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Measurement of infant's development
Management information
Registered date
| 2018 | Year | 08 | Month | 07 | Day |
Last modified on
| 2026 | Year | 04 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038377
