UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021867 |
|---|---|
| Receipt number | R000025212 |
| Scientific Title | Efficacy of Phototherapy Using Blue Light-Emitting Diodes In Japanese Neonates: A Prospective Nested Case-Control Study |
| Date of disclosure of the study information | 2016/05/01 |
| Last modified on | 2018/04/13 09:59:23 |
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Basic information
Public title
Efficacy of Phototherapy Using Blue Light-Emitting Diodes In Japanese Neonates:
A Prospective Nested Case-Control Study
Acronym
Efficacy of Phototherapy Using Blue Light-Emitting Diodes In Japanese Neonates:
A Prospective Nested Case-Control Study
Scientific Title
Efficacy of Phototherapy Using Blue Light-Emitting Diodes In Japanese Neonates:
A Prospective Nested Case-Control Study
Scientific Title:Acronym
Efficacy of Phototherapy Using Blue Light-Emitting Diodes In Japanese Neonates:
A Prospective Nested Case-Control Study
Region
| Japan |
Condition
Condition
neonatal jaundice
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the therapeutic effect of LED PT compared to that of blue FT in a prospective nested case-control study.
Basic objectives2
Others
Basic objectives -Others
To investigate the therapeutic effect of LED PT compared to that of another LED in a prospective nested case-control study.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Percent decrease of TB values before and after PT.
Key secondary outcomes
Increase rate of TB values 24 hours after completion of PT.
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
| 0 | days-old | <= |
Age-upper limit
| 14 | days-old | >= |
Gender
Male and Female
Key inclusion criteria
Newborns with a gestational age of 36 weeks or more, idiopathic jaundice
Key exclusion criteria
Newborns with a high direct bilirubin,and hemolytic jaundice
Target sample size
75
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ichiro Morioka |
Organization
Kobe University Graduate School of Medicine
Division name
Department of Pediatrics
Zip code
Address
7-5-2 Kusunoki-cho, chuo-Ku, Kobe, Hyogo 650-0017, Japan
TEL
0783826190
ichim@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ichiro Morioka |
Organization
Kobe University Graduate School of Medicine
Division name
Department of Pediatrics
Zip code
Address
7-5-2 Kusunoki-cho, chuo-Ku, Kobe, Hyogo 650-0017, Japan
TEL
0783826190
Homepage URL
ichim@med.kobe-u.ac.jp
Sponsor or person
Institute
Department of Pediatrics, Kobe University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Pediatrics, Kobe University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Self funding
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
| 2016 | Year | 05 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2014 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 04 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2018 | Year | 03 | Month | 01 | Day |
Other
Other related information
nothing
Management information
Registered date
| 2016 | Year | 04 | Month | 11 | Day |
Last modified on
| 2018 | Year | 04 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025212
