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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000034400
Receipt No. R000039225
Scientific Title Effects of using infant pillows continuously for affecting motor development in preterm infants
Date of disclosure of the study information 2018/11/01
Last modified on 2019/10/08

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Basic information
Public title Effects of using infant pillows continuously for affecting motor development in preterm infants
Acronym Effects of using infant pillows for affecting motor development in preterm infants
Scientific Title Effects of using infant pillows continuously for affecting motor development in preterm infants
Scientific Title:Acronym Effects of using infant pillows for affecting motor development in preterm infants
Region
Japan

Condition
Condition Preterm infants
Classification by specialty
Pediatrics Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To study the effects of using infant pillows continuously for preterm infant motor developments and head shapes.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Alberta Infant Motor Scale
Bayley Scales of Infant and Toddler Development, Third Edition(Bayley-3)
General Movements
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 Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Use infant pillow from 36-40 weeks corrected age to 3 months
Interventions/Control_2 control
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 weeks-old <
Age-upper limit
4 weeks-old >=
Gender Male and Female
Key inclusion criteria Less than 37 weeks at birth
Less than 1,800 g at birth
In the Tokyo Women s Medical University Hospital
Informed consent to participate to the study is obtained from the parents
Key exclusion criteria Subjects diagnosed chromosomal abnormality or neuromuscular disease
Subjects judged by the doctors to have neurological disorders
Subjects judged by the investigators to be inappropriate as study subjects
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tetsuo Ikai
Organization Tokyo Womens Medical University
Division name Department of Rehabilitation Medicine
Zip code
Address 8-1, Kawadacho, Shinjyuku-ku, Tokyo, Japan
TEL 03-3353-8111
Email ikai.tetsuo@twmu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yuu Uchio
Organization Tokyo Womens Medical University
Division name Department of Rehabilitation
Zip code
Address 8-1, Kawadacho, Shinjyuku-ku, Tokyo, Japan
TEL 03-3353-8111
Homepage URL
Email uchio.yu@twmu.ac.jp

Sponsor
Institute Tokyo Womens Medical University
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Tokyo Metropolitan University
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2018 Year 11 Month 01 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
2018 Year 10 Month 05 Day
Date of IRB
Anticipated trial start date
2018 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 10 Month 06 Day
Last modified on
2019 Year 10 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039225

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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