UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022080 |
|---|---|
| Receipt number | R000025458 |
| Scientific Title | Effects of Positioning for Very Low Birth Weight Infant Movements Three Dimensional Data Analysis |
| Date of disclosure of the study information | 2016/05/28 |
| Last modified on | 2019/03/04 22:39:51 |
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Basic information
Public title
Effects of Positioning for Very Low Birth Weight Infant Movements
Three Dimensional Data Analysis
Acronym
Effects of Positioning for Very Low Birth Weight Infants
Scientific Title
Effects of Positioning for Very Low Birth Weight Infant Movements
Three Dimensional Data Analysis
Scientific Title:Acronym
Effects of Positioning for Very Low Birth Weight Infants
Region
| Japan |
Condition
Condition
1.Very Low Birth Weight Infants
2.Term Infants
Classification by specialty
| Pediatrics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To study the immediate effects of positioning for very low birth weight infant movements.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
immediate changes of the arms and legs movements after two minutes of positioning intervention
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Factorial
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
Evaluate with and without positioning mats
Interventions/Control_2
Evaluate without positioning mats
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
| 0 | weeks-old | <= |
Age-upper limit
| 8 | weeks-old | >= |
Gender
Male and Female
Key inclusion criteria
Very low birth weight infants weighing less than 1500 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 judged by the doctors to have neurological disorders
Subjects need the mechanical ventilators or oxygen therapy
Subjects judged by the investigators to be inappropriate as study subjects
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tetsuo Ikai |
Organization
Tokyo Women's Medical University
Division name
Department of Rehabilitation
Zip code
Address
8-1, Kawadacho, Shinjyuku-ku, Tokyo, Japan
TEL
03-3353-8111
ikai.tetsuo@twmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuu Uchio |
Organization
Tokyo Women's Medical University
Division name
Department of Rehabilitation
Zip code
Address
8-1, Kawadacho, Shinjyuku-ku, Tokyo, Japan
TEL
03-3353-8111
Homepage URL
uchio.yu@twmu.ac.jp
Sponsor or person
Institute
Tokyo Women's Medical University
Institute
Department
Personal name
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
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
| 2016 | Year | 05 | Month | 28 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.jstage.jst.go.jp/article/rigaku/advpub/0/advpub_11438/_article/-char/ja
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
Main results already published
Date of protocol fixation
| 2016 | Year | 01 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 04 | Month | 28 | Day |
Last follow-up date
| 2017 | Year | 02 | Month | 15 | Day |
Date of closure to data entry
| 2017 | Year | 02 | Month | 15 | Day |
Date trial data considered complete
| 2017 | Year | 02 | Month | 15 | Day |
Date analysis concluded
| 2017 | Year | 02 | Month | 15 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 04 | Month | 26 | Day |
Last modified on
| 2019 | Year | 03 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025458
