UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000062226 |
|---|---|
| Receipt number | R000071207 |
| Scientific Title | An Exploratory Study of the Implementation Outcomes and Challenges of a Positional Cranial Deformity Prevention Program for Preterm Infants in the NICU |
| Date of disclosure of the study information | 2026/07/13 |
| Last modified on | 2026/07/13 21:52:55 |
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Basic information
Public title
Evaluation of a Positional Cranial Deformity Prevention Program for Preterm Infants in the NICU
Acronym
NICU-PCD Study
Scientific Title
An Exploratory Study of the Implementation Outcomes and Challenges of a Positional Cranial Deformity Prevention Program for Preterm Infants in the NICU
Scientific Title:Acronym
Preterm PCD Study
Region
| Japan |
Condition
Condition
Positional Cranial Deformity
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to implement a newly developed positional cranial deformity prevention program for preterm infants admitted to the NICU of our hospital and to evaluate its effectiveness and implementation challenges.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Completion rate of the positional cranial deformity prevention program until discharge
Key secondary outcomes
1. Barriers to implementation of the positional cranial deformity prevention program
2. Safety (occurrence of deterioration in general condition or adverse events)
3. Cranial shape at the start and end of the intervention (CI, CVAI, and OPS)
4. Clinical factors associated with program implementation (gestational age, birth weight, duration of respiratory support, duration of incubator care, etc.)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
A positional cranial deformity prevention program will be implemented for preterm infants admitted to the NICU. The program consists of 1) head assessment three times daily, 2) repositioning every 2 to 3 hours including during feeding and nursing care, 3) head support during feeding, and 4) tummy time for 10 to 20 minutes three times daily under nurse supervision with cardiorespiratory monitoring.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Infants whose parent or legal guardian provides informed consent for study participation within 2 weeks after admission (consent from either the mother or father is acceptable).
Infants born at less than 34 weeks of gestation.
Key exclusion criteria
Infants with extremely low birth weight (birth weight less than 1000 g).
Infants with congenital anomaly syndromes (including chromosomal abnormalities, muscular torticollis, and craniosynostosis).
Infants with severe neonatal asphyxia.
Infants requiring surgical intervention.
Infants who are considered inappropriate for participation in this study by the principal investigator.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Hara |
| Middle name | |
| Last name | Shiori |
Organization
Fukuoka University Hospital
Division name
Department of Nursing, Maternal and Perinatal Center, Neonatal Division
Zip code
814-0180
Address
7-45-1 Nanakuma, Jonan-ku, Fukuoka City, Fukuoka, Japan
TEL
092-801-1011
shiori19911023@adm.fukuoka-u.ac.jp
Public contact
Name of contact person
| 1st name | Hara |
| Middle name | |
| Last name | Shiori |
Organization
Fukuoka University Hospital
Division name
Department of Nursing, Maternal and Perinatal Center, Neonatal Division
Zip code
814-0180
Address
7-45-1 Nanakuma, Jonan-ku, Fukuoka City, Fukuoka, Japan
TEL
092-801-1011
Homepage URL
shiori19911023@adm.fukuoka-u.ac.jp
Sponsor or person
Institute
Fukuoka University
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
Fukuoka University Institutional Review Board
Address
7-45-1 Nanakuma, Jonan-ku, Fukuoka City, Fukuoka, Japan
Tel
092-801-1011
fumed-ethics@fukuoka-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
| 2026 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 07 | Month | 14 | Day |
Last follow-up date
| 2028 | 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
| 2026 | Year | 07 | Month | 13 | Day |
Last modified on
| 2026 | 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=R000071207
