UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049632 |
|---|---|
| Receipt number | R000056413 |
| Scientific Title | A study to clarify changes of cranial shape with the use of prevention pillows for cranial deformity in early infancy |
| Date of disclosure of the study information | 2023/01/15 |
| Last modified on | 2025/06/04 11:05:12 |
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Basic information
Public title
A study to clarify changes of cranial shape with the use of prevention pillows for cranial deformity in early infancy
Acronym
A study to clarify changes of cranial shape with the use of prevention pillows for cranial deformity in early infancy
Scientific Title
A study to clarify changes of cranial shape with the use of prevention pillows for cranial deformity in early infancy
Scientific Title:Acronym
A study to clarify changes of cranial shape with the use of prevention pillows for cranial deformity in early infancy
Region
| Japan |
Condition
Condition
Positional Plagiocephaly
Classification by specialty
| Pediatrics | Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To identify whether prevention pillows could prevent plagiocephaly and brachycephaly in early infancy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cranial Asymmetry,Cranial Vault Asymmetry Index at 1 and 3 months of age
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
The use of prevention pillows for head deformities
Starting from birth to 3 months old
Interventions/Control_2
No use of prevention pillows for head deformities
Starting from birth to 3 months old
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 | days-old | <= |
Age-upper limit
| 4 | months-old | > |
Gender
Male and Female
Key inclusion criteria
Healthy new borns at term birth.
Key exclusion criteria
New borns at preterm birth
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Ichiro |
| Middle name | |
| Last name | Morioka |
Organization
Department of Pediatrics and Child Health, Nihon University School of Medicine
Division name
Pediatrics
Zip code
173-8610
Address
30-1 Oyaguchi-kamimachi, Itabashi-ku, Tokyo
TEL
03-3972-8111
morioka.ichiro@med.nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | Risa |
| Middle name | |
| Last name | Kato |
Organization
Department of Pediatrics and Child Health, Nihon University School of Medicine
Division name
Pediatrics
Zip code
173-8610
Address
30-1 Oyaguchi-kamimachi, Itabashi-ku, Tokyo
TEL
03-3972-8111
Homepage URL
kato.risa@nihon-u.ac.jp
Sponsor or person
Institute
Department of Pediatrics and Child Health, Nihon University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nihon University Itabashi Hospital, Clinical Research Judging Committee
Address
30-1 Oyaguchi-kamimachi, Itabashi-ku, Tokyo
Tel
03-3972-8111
med.rinsyokenkyu@nihon-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 | 01 | Month | 15 | 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
The symmetry-related parameters of cranial deformities were more pronounced worse at 1 month than at birth, with a substantially higher median CVAI of 4.9% versus 2.1%, respectively (p <0.01). The prevalence of PDP increased significantly from 19.2% at birth to 66.1% at 1month of age.
Results date posted
| 2024 | Year | 11 | Month | 29 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
Due to analysis in progress.
Date of the first journal publication of results
Baseline Characteristics
A total of 130 newborns with a mean gestational age of 39 weeks, mean birth
weight of 3,075 g, mean head circumference of 33.5 cm, and male sex ratio of 48.5% were
included. The mean day age at measurement was 3.3 days.
Participant flow
Adverse events
None.
Outcome measures
Cranial Vault Asymmetry Index
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 10 | Month | 17 | Day |
Date of IRB
| 2022 | Year | 11 | Month | 09 | Day |
Anticipated trial start date
| 2023 | Year | 02 | Month | 28 | Day |
Last follow-up date
| 2024 | Year | 03 | 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
| 2022 | Year | 11 | Month | 28 | Day |
Last modified on
| 2025 | Year | 06 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056413
