UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011224 |
|---|---|
| Receipt number | R000013151 |
| Scientific Title | Screening for biliary atresia using digital photos with stool color card. |
| Date of disclosure of the study information | 2013/07/18 |
| Last modified on | 2021/01/26 13:03:07 |
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Basic information
Public title
Screening for biliary atresia using digital photos with stool color card.
Acronym
Screening for biliary atresia using digital photos with stool color card.
Scientific Title
Screening for biliary atresia using digital photos with stool color card.
Scientific Title:Acronym
Screening for biliary atresia using digital photos with stool color card.
Region
| Japan |
Condition
Condition
biliary atresia
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To improve an early checkup rate of the biliary atresia easily by judging the stool color using the photograph of the cell-phone from newborn to three months old.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
usefulness of the judgment method of the stool color using the color card
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
We direct mother after the delivery to have us e-mail a photograph of the stool of the neonate or infant and judge presence of the stool color abnormality.
We have mother e-mail it by three months after birth.
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
| 0 | months-old | <= |
Age-upper limit
| 3 | months-old | >= |
Gender
Male and Female
Key inclusion criteria
We study it for full-term newborn babies. We explain about study to mother and obtain its consent. Mother of the babies use cell phone and mail a photo to us.
Key exclusion criteria
We exclude the patient who does not meet the criteria for selection mentioned above.
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroko Watayo |
Organization
Juntendo University School of Medicine
Division name
Pediatric General & Urogenital Surgery
Zip code
Address
2-1-1 Hongo, Bunkyo-ku Tokyo
TEL
03-3813-3111
watayo@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroko Watayo |
Organization
Juntendo University School of Medicine
Division name
Pediatric General & Urogenital Surgery
Zip code
Address
2-1-1 Hongo, Bunkyo-ku Tokyo
TEL
03-3813-3111
Homepage URL
http://plaza.umin.ac.jp/unchiproject/
unchi-project@umin.org
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
| 2013 | Year | 07 | Month | 18 | 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
Completed
Date of protocol fixation
| 2013 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2013 | Year | 02 | Month | 19 | Day |
Anticipated trial start date
| 2013 | Year | 07 | Month | 18 | Day |
Last follow-up date
| 2019 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2019 | Year | 07 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 08 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 07 | Month | 18 | Day |
Last modified on
| 2021 | Year | 01 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013151
