UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040739 |
|---|---|
| Receipt number | 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 | 2022/01/14 10:38:47 |
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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
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
kmiyaba@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University School of Medicine
Institute
Department
Personal name
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
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
| 2022 | Year | 01 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046511
