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Name
UMIN ID

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000024352
Receipt No. R000027328
Scientific Title A prospective multicenter non-inferiority randomized controlled trial of the irradiance level of phototherapy for neonatal jaundice
Date of disclosure of the study information 2016/10/28
Last modified on 2021/10/18

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Basic information
Public title A prospective multicenter non-inferiority randomized controlled trial of the irradiance level of phototherapy for neonatal jaundice
Acronym A prospective trial of the irradiance level of phototherapy for neonatal jaundice
Scientific Title A prospective multicenter non-inferiority randomized controlled trial of the irradiance level of phototherapy for neonatal jaundice
Scientific Title:Acronym A prospective trial of the irradiance level of phototherapy for neonatal jaundice
Region
Japan

Condition
Condition neonatal jaundice
Classification by specialty
Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this trial is to show that the low irradiance level is not worse than the high irradiance level in the phototherapy for neonatal jaundice.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Retreatment rate of neonatal jaundice
Key secondary outcomes Reduction rate of serum bilirubin levels

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 High level irradiation; the target irradiance level is 30-35uW per square centimeter per
nanometer of wavelength
Interventions/Control_2 Low level irradiation; the target irradiance level is 12-15uW per square centimeter per
nanometer of wavelength
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
2 days-old <=
Age-upper limit
4 days-old >=
Gender Male and Female
Key inclusion criteria Asian full-term neonates with jaundice between 48 and 96 hours of age.
Key exclusion criteria Patients with low-birth-weight, early on set jaundice, perinatal asphyxia, antimicrobial therapy or respiratory disorder.
Patients with jaundice caused by hemolysis, or functional or anatomic obstruction.
Patients who need treatments except for phototherapy.
Target sample size 300

Research contact person
Name of lead principal investigator
1st name Yoshiaki
Middle name
Last name Sato
Organization Nagoya University Hospital
Division name Division of Neonatology, Center for Maternal-Neonatal Care
Zip code 466-8560
Address 65 Tsurumai-cho Showa-ku, Nagoya 466-8560, Japan
TEL +81-(0)52-744-2294
Email yoshiaki@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name Horiba
Middle name
Last name Kazuhiro
Organization Nagoya University Graduate School of Medicine
Division name Department of Pediatrics
Zip code 466-8560
Address 65 Tsurumai-cho Showa-ku, Nagoya 466-8550, Japan
TEL +81-(0)52-744-2294
Homepage URL
Email khoriba@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya University Graduate School of Medicine
Department of Pediatrics
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor Anjo Kosei Hospital
Kasugai Municipal Hospital
Handa Hospital
TOYOTA Memorial Hospital
National Hospital Organization Nagoya Medical Center
Japan Red Cross Nagoya Daiichi Hospital
Hekinan Municipal Hospital
Ogaki Municipal Hospital


Name of secondary funder(s)

IRB Contact (For public release)
Organization Nagoya University Hospital IRB
Address 65 Tsurumai-cho Showa-ku, Nagoya 466-8550, Japan
Tel 052-741-2111
Email camcr@med.nagoya-u.ac.jp

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 安生更生病院(愛知県)、春日井市民病院(愛知県)、市立半田病院(愛知県)、トヨタ記念病院(愛知県)、名古屋医療センター(愛知県)、名古屋第一赤十字病院(愛知県)、名古屋大学医学部附属病院(愛知県)、碧南市民病院(愛知県)





Other administrative information
Date of disclosure of the study information
2016 Year 10 Month 28 Day

Related information
URL releasing protocol
Publication of results Unpublished

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 Open public recruiting
Date of protocol fixation
2016 Year 07 Month 20 Day
Date of IRB
2017 Year 01 Month 25 Day
Anticipated trial start date
2017 Year 03 Month 01 Day
Last follow-up date
2023 Year 02 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 10 Month 11 Day
Last modified on
2021 Year 10 Month 18 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027328

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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