UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060103 |
|---|---|
| Receipt number | R000068744 |
| Scientific Title | A Study on the Effects of Timing in Toy-Based Group Work Interventions on Development and Maternal Psychology in Preterm Infants |
| Date of disclosure of the study information | 2025/12/18 |
| Last modified on | 2025/12/17 14:28:49 |
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Basic information
Public title
A Study on the Effects of Timing in Toy-Based Group Work Interventions on Development and Maternal Psychology in Preterm Infants
Acronym
A Study on the Effects of Timing in Toy-Based Group Work Interventions on Development and Maternal Psychology in Preterm Infants
Scientific Title
A Study on the Effects of Timing in Toy-Based Group Work Interventions on Development and Maternal Psychology in Preterm Infants
Scientific Title:Acronym
A Study on the Effects of Timing in Toy-Based Group Work Interventions on Development and Maternal Psychology in Preterm Infants
Region
| Japan |
Condition
Condition
preterm infant
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study examines the effects of differing start times for developmental support interventions on the development of preterm infants and the psychological well-being of their mothers.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Bayley III Infant Developmental Assessment Results at 18 Months and 3 Years of Age
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Toys are provided monthly for a total of 6 sessions at 1 year old. Receipt occurs monthly during outpatient visits. Our clinical psychologist instructs mothers each time on toy utilization methods and developmentally stimulating play approaches, then conducts group work sessions gathering children of the same age.
Interventions/Control_2
Toys are provided monthly for a total of 6 sessions at 1 and 6 month year old. Receipt occurs monthly during outpatient visits. Our clinical psychologist instructs mothers each time on toy utilization methods and developmentally stimulating play approaches, then conducts group work sessions gathering children of the same age.
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 | years-old | <= |
Age-upper limit
| 3 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
preterm infants less than gestational age 32 weeks
Key exclusion criteria
Infants and their mothers deemed inappropriate by the principal investigator, including those with congenital disorders, severe intraventricular hemorrhage (grade 3 or 4), or non-native Japanese speakers.
Target sample size
74
Research contact person
Name of lead principal investigator
| 1st name | Taketoshi |
| Middle name | |
| Last name | Yoshida |
Organization
TOYAMA UNIVERSITY HOSPITAL
Division name
Maternal and Perinatal Center
Zip code
930-0194
Address
2630 Sugitani, TOYAMA, JAPAN
TEL
076-434-7313
ytake@med.u-toyama.ac.jp
Public contact
Name of contact person
| 1st name | Taketoshi |
| Middle name | |
| Last name | Yoshida |
Organization
TOYAMA UNIVERSITY HOSPITAL
Division name
Maternal and Perinatal Center
Zip code
9300194
Address
2630 Sugitani, TOYAMA, JAPAN
TEL
09013907931
Homepage URL
ytake@med.u-toyama.ac.jp
Sponsor or person
Institute
Toyama university hospital
Institute
Department
Personal name
Funding Source
Organization
Chronology of the Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Toyama university hospital
Address
2630 Sugitani, TOYAMA, JAPAN
Tel
07050647931
rinken@adm.u-toyama.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
| 2025 | Year | 12 | Month | 18 | 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
| 2025 | Year | 12 | Month | 10 | Day |
Date of IRB
| 2025 | Year | 12 | Month | 10 | Day |
Anticipated trial start date
| 2026 | Year | 01 | Month | 15 | Day |
Last follow-up date
| 2028 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 12 | Month | 17 | Day |
Last modified on
| 2025 | Year | 12 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068744
