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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000035357
Receipt No. R000040287
Scientific Title Effect of moisturizer application on perianal area in neonates; Comparison of effects on erythema and skin barrier function at 1-month checkup
Date of disclosure of the study information 2018/12/25
Last modified on 2018/12/25

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Basic information
Public title Effect of moisturizer application on perianal area in neonates; Comparison of effects on erythema and skin barrier function at 1-month checkup
Acronym Effect of moisturizer application on perianal area in neonates
Scientific Title Effect of moisturizer application on perianal area in neonates; Comparison of effects on erythema and skin barrier function at 1-month checkup
Scientific Title:Acronym Effect of moisturizer application on perianal area in neonates
Region
Japan

Condition
Condition Pregnant women and women after deliverly, neonate
Classification by specialty
Obsterics and gynecology Nursing
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The object of this study is to clarify the effectiveness of moisturizer application on perianal area of neonate on erythema and skin barrier function at 1-month checkup.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Presence or absence of erythema on perianal area
Key secondary outcomes 1.Presence or absence of papule and erosin on perianal area
2.Skin barrier function(TEWL,SCH,pH,number of microbial colonization)
3.Questionnaires(about skin care, change diaper)

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
Behavior,custom Maneuver
Interventions/Control_1 Intervention group;
Apply moisturizer on perianal area after every wiping the buttocks
Interventions/Control_2 Comparison group;
usual care
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 days-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1.Newborn of primipara with full term deliverly
2.Newborn who can manage in the neonatal room
3.Newborn who can visit 1-month checkup at research hospital
4.Written informed consent
Key exclusion criteria 1.Newborn who changed to NICU
2.Newborn with infection by virus or bacterial
3.Newborn with skin desease
4.Mother with mental illness treating medication
Target sample size 220

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasue Kobayashi
Organization University of Yamanashi
Division name Graduate Faculty of Interdisciplinary Research
Zip code
Address 1110 Shimokato, Chuo City, Yamanashi Pref, 409-3898, Japan
TEL 055-273-8614
Email yasue@yamanashi.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yuka Majima
Organization University of Yamanashi
Division name Division of Nursing and Health Science, Graduate School of Medicine and Engineering
Zip code
Address 1110 Shimokato, Chuou City, Yamanashi Pref, 409-3898, Japan
TEL 055-273-1111(ext.2755)
Homepage URL
Email yk-majima@umin.ac.jp

Sponsor
Institute University of Yamanashi
Institute
Department

Funding Source
Organization Natural Science Co.,Ltd.
Organization
Division
Category of Funding Organization Profit organization
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

Other administrative information
Date of disclosure of the study information
2018 Year 12 Month 25 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 12 Month 21 Day
Date of IRB
Anticipated trial start date
2018 Year 12 Month 25 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 12 Month 25 Day
Last modified on
2018 Year 12 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040287

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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