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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000018110
Receipt No. 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

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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
Email 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
Email saori@koto.kpu-m.ac.jp

Sponsor
Institute University Hospital,Kyoto Prefectural University of Medicine
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020963

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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