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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000040739
Receipt No. R000046511
Scientific Title TransEpidermal WAter loss changes in Neonatal intensive care unit management
Date of disclosure of the study information 2020/07/01
Last modified on 2020/06/12

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Basic information
Public title A study of changes in transepidermal water loss on neonatal intensive care unit management
Acronym A study of changes in transepidermal water loss on neonatal intensive care unit management
Scientific Title TransEpidermal WAter loss changes in Neonatal intensive care unit management
Scientific Title:Acronym TEWAN study
Region
Japan

Condition
Condition term or preterm infant
Classification by specialty
Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate changes in skin appearance in newborns admitted to the neonatal intensive care unit. Then, we will determine if it is related to the later development of allergic diseases.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The changes of tranepidermal water loss (TEWL) during the course of treatment and differences by treatment intervention
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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 All newborn babies admitted to the Neonatal Intensive Care Unit of Juntendo University Shizuoka Hospital
Key exclusion criteria A baby whose general condition is unstable and judged inappropriate by the attending doctor.
Target sample size 500

Research contact person
Name of lead principal investigator
1st name Yosuke
Middle name
Last name Baba
Organization Juntendo University Shizuoka Hospital
Division name Department of Pediatrics and Neonatology
Zip code 4112295
Address 1129 Nagaoka, Izuno-kuni, Shizuoka, Japan
TEL +81-55-948-3111
Email youbaba@juntendo.ac.jp

Public contact
Name of contact person
1st name Kazuki
Middle name
Last name Miyabayashi
Organization Juntendo University Shizuoka Hospital
Division name Department of Pediatrics and Neonatology
Zip code 4112295
Address 1129 Nagaoka, Izuno-kuni, Shizuoka, Japan
TEL +81-55-948-3111
Homepage URL
Email kmiyaba@juntendo.ac.jp

Sponsor
Institute Juntendo University School of Medicine
Institute
Department

Funding Source
Organization Grant-in-Aid for Special Research in Subsidies for ordinary expenses of private schools from The Promotion and Mutual Aid Corporation for Private Schools of Japan
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Juntendo University Shizuoka Hospital Good Clinical Practice Center
Address 1129 Nagaoka, Izuno-kuni, Shizuoka, Japan
Tel +81-55-948-3111
Email gcpjun@mtc.biglobe.ne.jp

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
2020 Year 07 Month 01 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
2020 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2020 Year 07 Month 01 Day
Last follow-up date
2023 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information N/A

Management information
Registered date
2020 Year 06 Month 12 Day
Last modified on
2020 Year 06 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046511

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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