UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024404 |
|---|---|
| Receipt number | R000028018 |
| Scientific Title | A multicenter study of retinopathy of prematurity in Yamagata Prefecture, Japan |
| Date of disclosure of the study information | 2016/11/01 |
| Last modified on | 2019/12/04 19:25:34 |
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Basic information
Public title
A multicenter study of retinopathy of prematurity in Yamagata Prefecture, Japan
Acronym
A multicenter study of retinopathy of prematurity in Yamagata Prefecture, Japan
Scientific Title
A multicenter study of retinopathy of prematurity in Yamagata Prefecture, Japan
Scientific Title:Acronym
A multicenter study of retinopathy of prematurity in Yamagata Prefecture, Japan
Region
| Japan |
Condition
Condition
Retinopathy of prematurity
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the epidemiology of retinopathy of prematurity by examining the preference rate and treatment rate.
Basic objectives2
Others
Basic objectives -Others
To identify factors correlated with the occurrence and progression of retinopathy of prematurity.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Factors correlated with the occurrence and progression of retinopathy of prematurity
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Premature infants whose parents agreed with participating in this study.
Premature infants examined by ophthalmologist on the purpose of screening for retinopathy of prematurity.
Key exclusion criteria
Premature infants whose parents disagreed with participating this study.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Hidetoshi |
| Middle name | |
| Last name | Yamashita |
Organization
Yamagata University Faculty of Medicine
Division name
Department of Ophthalmology and Visual Sciences
Zip code
990-9585
Address
2-2-2 Iidanishi, Yamagata-shi, Yamagata, 990-2332, Japan
TEL
023-628-5374
hyama-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | Yusuke |
| Middle name | |
| Last name | Takeda |
Organization
Yamagata University Faculty of Medicine
Division name
Department of Ophthalmology and Visual Sciences
Zip code
990-9585
Address
2-2-2 Iidanishi, Yamagata-shi, Yamagata, 990-2332, Japan
TEL
023-628-5374
Homepage URL
y-takeda@med.id.yamagata-u.ac.jp
Sponsor or person
Institute
Department of Ophthalmology and Visual Sciences, Yamagata University Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
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
Yamaga University Facultiy od Medicine Institutional Review Board
Address
2-2-2 Iidanishi, Yamagata
Tel
023-628-5047
ikekenkyu@jm.kj.yamagata-u.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
山形大学医学部付属病院
山形県立中央病院
山形済生病院
鶴岡市立荘内病院
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 11 | 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
Open public recruiting
Date of protocol fixation
| 2016 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 06 | Month | 22 | Day |
Anticipated trial start date
| 2016 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 10 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 11 | Month | 30 | Day |
Date analysis concluded
| 2020 | Year | 03 | Month | 31 | Day |
Other
Other related information
A multicenter, prospective, observation study.
We collecte date over one year.
Management information
Registered date
| 2016 | Year | 10 | Month | 14 | Day |
Last modified on
| 2019 | Year | 12 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028018
