UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035357 |
|---|---|
| Receipt number | 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 | 2020/01/10 10:11:35 |
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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
| Obstetrics 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
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
yk-majima@umin.ac.jp
Sponsor or person
Institute
University of Yamanashi
Institute
Department
Personal name
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
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
118
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
Completed
Date of protocol fixation
| 2018 | Year | 12 | Month | 21 | Day |
Date of IRB
| 2018 | Year | 11 | Month | 06 | Day |
Anticipated trial start date
| 2018 | Year | 12 | Month | 25 | Day |
Last follow-up date
| 2019 | Year | 10 | Month | 31 | Day |
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
| 2020 | Year | 01 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040287
