UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018110 |
|---|---|
| Receipt number | R000020963 |
| Scientific Title | Preliminary study on the skin cleaning method without cleaning agent during bathing in the NICU -Comparison with the case of using a skin cleaning agent- |
| Date of disclosure of the study information | 2015/06/26 |
| Last modified on | 2015/06/26 22:26:48 |
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Basic information
Public title
Preliminary study on the skin cleaning method without cleaning agent during bathing in the NICU
-Comparison with the case of using a skin cleaning agent-
Acronym
Preliminary study on the skin cleaning method without cleaning agent during bathing in the NICU
Scientific Title
Preliminary study on the skin cleaning method without cleaning agent during bathing in the NICU
-Comparison with the case of using a skin cleaning agent-
Scientific Title:Acronym
Preliminary study on the skin cleaning method without cleaning agent during bathing in the NICU
Region
| Japan |
Condition
Condition
Premature infants
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Preliminary study on premature infants
less than 37 weeks gestational age, to
conservation of epidelma barrier function
and dry skin prevention.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Evaluation for Skin's PH,moisture level and Oil amount.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Historical
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Group A:intervention phase(5days),Washout(2days),non intervention phase(5days)
Interventions/Control_2
Group B:non intervention phase(5days), Washout(2days),intervention phase(5days)
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
| 37 | weeks-old | > |
Gender
Male and Female
Key inclusion criteria
Premature infant less than 37 weeks gestational ages
Key exclusion criteria
Skin trouble
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Saori Kora |
Organization
University Hospital,Kyoto Prefectural University of Medicine
Division name
NICU
Zip code
Address
465 Kajiicyo,Hirokouji agaru, Kawaramachi douri, Kamigyou-ku, Kyoto Japan
TEL
075-251-5690
saori@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mariko Hashimoto |
Organization
University Hospital,Kyoto Prefectural University of Medicine
Division name
NICU
Zip code
Address
465 Kajiicyo,Hirokouji agaru, Kawaramachi douri, Kamigyou-ku, Kyoto Japan
TEL
075-251-5690
Homepage URL
saori@koto.kpu-m.ac.jp
Sponsor or person
Institute
University Hospital,Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Funding Source
Organization
University Hospital,Kyoto Prefectural University of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
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
京都府立医科大学附属病院 周産期NICU
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 06 | Month | 26 | 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
| 2015 | Year | 06 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 07 | Month | 03 | Day |
Last follow-up date
| 2015 | Year | 11 | Month | 01 | Day |
Date of closure to data entry
| 2016 | Year | 01 | Month | 01 | Day |
Date trial data considered complete
| 2016 | Year | 01 | Month | 01 | Day |
Date analysis concluded
| 2016 | Year | 01 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 06 | Month | 26 | Day |
Last modified on
| 2015 | Year | 06 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020963
