UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058447 |
|---|---|
| Receipt number | R000066827 |
| Scientific Title | Historical Controll Studn for the Prevention of Cranial Deformities in Infants |
| Date of disclosure of the study information | 2025/07/13 |
| Last modified on | 2025/07/13 00:47:16 |
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Basic information
Public title
Intervention Studies for the Prevention of Cranial Deformities in Infants
Acronym
Intervention Studies for the Prevention of Cranial Deformities in Infants
Scientific Title
Historical Controll Studn for the Prevention of Cranial Deformities in Infants
Scientific Title:Acronym
Historical Controll Studn for the Prevention of Cranial Deformities in Infants
Region
| Japan |
Condition
Condition
Plagiocephaly in infants
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To prevent cranial deformities in infants
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Assessment
Primary outcomes
Cranial deformation indices (cranial deformation rate, cranial asymmetry index, occipital symmetry rate, head length width index) at four month after birth
Key secondary outcomes
Cranial deformation indices (cranial deformation rate, cranial asymmetry index, occipital symmetry rate, head length width index) at 3 days and 1 month after birth
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
Distortion Prevention Methods
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
| 1 | days-old | < |
Age-upper limit
| 4 | months-old | >= |
Gender
Male and Female
Key inclusion criteria
As for the mothers, pregnant women undergoing antenatal care at 34-36 weeks' gestation.
For infants, infants born to mothers who participated in the study.
Key exclusion criteria
For mothers, a history of mental illness, etc.
For the child, there is no special provision.
Target sample size
260
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, Department of Reproductive Health
Zip code
8528520
Address
1-7-1 Sakamoto, Nagasaki
TEL
0958197922
heto@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Kiyota |
| Middle name | |
| Last name | Chiemi |
Organization
Nagasaki University
Division name
Institute of Biomedical Sciences
Zip code
852-8523
Address
1-12-4 Sakamoto, Nagasaki, 852-8523, JAPAN
TEL
095-819-7198
Homepage URL
chi0104@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University
Institute
Department
Personal name
Hiromi Eto
Funding Source
Organization
Nagasaki University
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
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
gakujutu_gakuji@ml.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
| 2025 | Year | 07 | Month | 13 | 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
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 03 | Month | 04 | Day |
Date of IRB
| 2025 | Year | 03 | Month | 04 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 30 | Day |
Last follow-up date
| 2027 | 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
| 2025 | Year | 07 | Month | 13 | Day |
Last modified on
| 2025 | Year | 07 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066827
