UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052342 |
|---|---|
| Receipt number | R000059748 |
| Scientific Title | The state of art of Japanese infant cranial deformation and exploration the relationship between cranial deformation in infants and sleep-related factors |
| Date of disclosure of the study information | 2023/09/28 |
| Last modified on | 2025/03/30 10:14:23 |
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Basic information
Public title
The state of art of Japanese infant cranial deformation and exploration the relationship between cranial deformation in infants and sleep-related factors
Acronym
Frequency of occurrence of cranial deformation and exploration of the factors
Scientific Title
The state of art of Japanese infant cranial deformation and exploration the relationship between cranial deformation in infants and sleep-related factors
Scientific Title:Acronym
Frequency of occurrence of cranial deformation and exploration of the factors
Region
| Japan |
Condition
Condition
cranial deformation
Classification by specialty
| Obstetrics and Gynecology | Pediatrics | Orthopedics |
| Neurosurgery | Rehabilitation medicine | Dental medicine |
| Nursing | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
1.Identify the frequency of occurrence of the actual distortion of the head shape at each stage of the infant's life (4 months, 1.5 years, and 3 years of age).
2.Explore the distortion of the head shape and its factors (conditions at the time of delivery, sleep-related content, and subjects' characteristics).
Basic objectives2
Others
Basic objectives -Others
Explore the frequency and factors of cranial deformation
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
cranial deformation rate(4 months, 1.5 years, and 3 years of age): Index of cranial asymmetry (CA), cranial vault asymmetry index(CVAI) and so on, by 3D scanner.
Key secondary outcomes
1.Physical measurements and conditions at the time of delivery of the child: The conditions at the time of delivery (number of weeks of gestation, mode of delivery, sex, birth weight, special notes at the time of delivery, etc.) will be determined from the Maternal and Child Health Handbook. In addition, physical measurements at the time of health examination and risk factors for orientation (birth order, nutritional method, cervical dystocia, hip opening/closing restriction, etc.) will be identified.
2.Sleep-related information: The Japanese version of the Brief Infant Sleep Questionnaire-Revised (BISQ-R) will be used to ascertain infants' total sleep time, nighttime and daytime sleep time, number of awakenings and awakening times, and caregiver responses when they fall asleep. The BISQ-R is used to ascertain the infant's total sleep time, nighttime and daytime sleep time, number of awakenings, and the caregiver's response to sleep onset. Questionnaire with 7 items related to family background and 33 items related to the child's sleep status
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
| 3 | months-old | <= |
Age-upper limit
| 40 | months-old | > |
Gender
Male and Female
Key inclusion criteria
The target population for the cranial measurements is 4 months, 1.5- and 3-year-old children undergoing infant health examinations. The caregivers (mainly mothers) of the children who can understand Japanese will be asked to answer the questionnaire.
Key exclusion criteria
Any disease or complication related to the cranium that is being seen.
Target sample size
750
Research contact person
Name of lead principal investigator
| 1st name | Hiromi |
| Middle name | |
| Last name | Eto |
Organization
Nagasaki University
Division name
Institute of Biomedical Sciences
Zip code
852-8520
Address
1-7-1 Sakamoto, Nagasaki, 852-8520, JAPAN
TEL
0958197922
heto@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Ikuko |
| Middle name | |
| Last name | Miyaji |
Organization
Nagasaki University
Division name
Institute of Biomedical Sciences
Zip code
852-8523
Address
1-12-4 Sakamoto, Nagasaki, 852-8520, JAPAN
TEL
095-819-7198
Homepage URL
miyaji195@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University
Institute
Department
Personal name
Funding Source
Organization
Japan Medical Company(collaborative research fund)
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagasaki University, Graduate School of Biomedical Sciences, Health Science Courses, Ethics Committee
Address
1-12-4 Sakamoto, Nagasaki, 852-8523, JAPAN
Tel
095-819-7198
miyaji195@nagasaki-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
| 2023 | Year | 09 | Month | 28 | 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 | 04 | Month | 21 | Day |
Date of IRB
| 2023 | Year | 05 | Month | 30 | Day |
Anticipated trial start date
| 2023 | Year | 05 | Month | 31 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2025 | Year | 04 | Month | 30 | Day |
Date analysis concluded
| 2025 | Year | 04 | Month | 30 | Day |
Other
Other related information
Obsevational Study/Cross Sectional Research
Management information
Registered date
| 2023 | Year | 09 | Month | 28 | Day |
Last modified on
| 2025 | Year | 03 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059748
