UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050037 |
|---|---|
| Receipt number | R000057002 |
| Scientific Title | Observational research using vital information monitors and images |
| Date of disclosure of the study information | 2023/01/14 |
| Last modified on | 2023/01/14 11:25:11 |
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Basic information
Public title
Development of non-contact biological information measurement method for healthy newborns
Acronym
Development of non-contact biological information measurement method for healthy newborns
Scientific Title
Observational research using vital information monitors and images
Scientific Title:Acronym
Observational research using vital information monitors and images
Region
| Japan |
Condition
Condition
newborns
Classification by specialty
| Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to verify the usefulness of the non-contact biological information measurement method for newborns.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Compare ECG monitor with vital signs calculated from images
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
| 3 | days-old | <= |
Age-upper limit
| 6 | days-old | >= |
Gender
Male and Female
Key inclusion criteria
Gestational age: 37 weeks or more and less than 42 weeks
Birth weight: 2,500 g or more and less than 4,000 g
No complications
Key exclusion criteria
Deviation from normal range of vital signs
Deviation from physiological weight loss
Poor suckling power
Deviation from physiological jaundice
Mother's physical and psychological deviations from normal
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yuki |
| Middle name | |
| Last name | Kanazawa |
Organization
University of Tsukuba
Division name
Faculty of Medicine
Zip code
305-8575
Address
1-1-1 Tennodai, Tsukuba, Ibaraki 305-8575, Japan
TEL
0298533985
ykanazawa@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Kanazawa |
Organization
University of Tsukuba
Division name
Faculty of Medicine
Zip code
305-8575
Address
1-1-1 Tennodai, Tsukuba, Ibaraki 305-8575, Japan
TEL
0298533985
Homepage URL
ykanazawa@md.tsukuba.ac.jp
Sponsor or person
Institute
others
Institute
Department
Personal name
Funding Source
Organization
others
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of Tsukuba Hospital Clinical Research Ethics Review Committee
Address
2-1-1 Tennodai, Tsukuba, Ibaraki
Tel
029-853-3914
t-credo.adm@un.tsukuba.ac.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
| 2023 | Year | 01 | Month | 14 | 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
| 2022 | Year | 09 | Month | 08 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 19 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 30 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A researcher calls out to the mother while the infant is asleep.
Move the infant to the neonatal unit. Then, move the baby to the open base (infant warmer) and warm it according to the body temperature.
After preparation, the child's thorax and abdomen (above the navel) from below the cheek is photographed with a development camera for about 30 minutes.
It takes about 90 minutes from the start of the survey to the end of the survey.
Management information
Registered date
| 2023 | Year | 01 | Month | 14 | Day |
Last modified on
| 2023 | Year | 01 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057002
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
