UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000016789
Receipt number 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 09:24:06

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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 or person

Institute

Shikoku Medical Center for Children and Adults

Institute

Department

Personal name



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

Value
https://center6.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