UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy of Phototherapy Using Blue Light-Emitting Diodes In Japanese Neonates: A Prospective Nested Case-Control Study
Title of the study (Brief title)	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	Ichiro Morioka
Organization	Kobe University Graduate School of Medicine
Division name	Department of Pediatrics
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	Ichiro Morioka
Organization	Kobe University Graduate School of Medicine
Division name	Department of Pediatrics
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 04 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000025212