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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016789
Receipt No. R000019483
Scientific Title A prospective randomized controlled study of phototherapy using green LED for neonatal hyperbilirubinemia
Date of disclosure of the study information 2015/04/01
Last modified on 2017/03/14

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Basic information
Public title A prospective randomized controlled study of phototherapy using green LED for neonatal hyperbilirubinemia
Acronym Green LED phototherapy study
Scientific Title A prospective randomized controlled study of phototherapy using green LED for neonatal hyperbilirubinemia
Scientific Title:Acronym Green LED phototherapy study
Region
Japan

Condition
Condition Neonatal hyperbilirubinemia
Classification by specialty
Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To determine the efficacy of green LED phototherapy for neonatal hyperbilirubinemia by comparison with blue LED phototherapy
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Reduction in total serum bilirubin levels
Key secondary outcomes Production of photoisomer
irradiance

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Green LED phototherapy
Interventions/Control_2 Blue LED phototherapy
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
36 weeks-old <=
Age-upper limit
42 weeks-old >
Gender Male and Female
Key inclusion criteria Newborns with neonatal hyperbilirubinemia who needs phototherapy, whose birth weight is grater than 2200g and gestational age at birth is grater than 36 weeks
Key exclusion criteria Newborns with chromosomal anomaly, multiple congenital anomaly, early onset jaundice, cholestasis,severe birth asphyxia, and those who were judged inappropriate by the principal investigator
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toru Kuboi
Organization Shikoku Medical Center for Children and Adults
Division name Neonatology
Zip code
Address 2-1-1, Senyu-cho, Zentsuji-shi, Kagawa, 765-8507, Japan
TEL 0877-62-1000
Email kuboi-t@shikoku-med.jp

Public contact
Name of contact person
1st name
Middle name
Last name Toru Kuboi
Organization Shikoku Medical Center for Children and Adults
Division name Neonatology
Zip code
Address 2-1-1, Senyu-cho, Zentsuji-shi, Kagawa, 765-8507, Japan
TEL 0877-62-1000
Homepage URL
Email kuboi-t@shikoku-med.jp

Sponsor
Institute Shikoku Medical Center for Children and Adults
Institute
Department

Funding Source
Organization National Hospital Organization
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor TOITU Co., LTD
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
2015 Year 04 Month 01 Day

Related information
URL releasing protocol
Publication of results Partially 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 10 Month 17 Day
Date of IRB
Anticipated trial start date
2015 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 03 Month 12 Day
Last modified on
2017 Year 03 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019483

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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