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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000021867
Receipt No. 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

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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
Email 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
Email ichim@med.kobe-u.ac.jp

Sponsor
Institute Department of Pediatrics, Kobe University Graduate School of Medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025212

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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