UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039677 |
|---|---|
| Receipt number | R000045257 |
| Scientific Title | A prospective randomized controlled study of the safty of phototherapy using green LED for neonatal hyperbilirubinemia |
| Date of disclosure of the study information | 2020/03/03 |
| Last modified on | 2025/03/09 17:35:07 |
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Basic information
Public title
A prospective randomized controlled study of the safty of phototherapy using green LED for neonatal hyperbilirubinemia
Acronym
Green LED phototherapy study
Scientific Title
A prospective randomized controlled study of the safty 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 safty of green LED phototherapy for neonatal hyperbilirubinemia by comparison with blue LED phototherapy
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The extent of DNA damage with the comet assay
Key secondary outcomes
Reduction in total serum bilirubin levels/Production of photoisomer/Rebound of bilirubin total serum bilirubin
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 | Takaaki |
| Middle name | |
| Last name | Sadamura |
Organization
Shikoku Medical Center for Children and Adults
Division name
Neonatology
Zip code
765-8507
Address
2-1-1, Senyu-cho, Zentsuji-shi, Kagawa, 765-8507, Japan
TEL
0877-62-1000
volttt2000@gmail.com
Public contact
Name of contact person
| 1st name | Takaaki |
| Middle name | |
| Last name | Sadamura |
Organization
Shikoku Medical Center for Children and Adults
Division name
Neonatology
Zip code
765-8507
Address
2-1-1, Senyu-cho, Zentsuji-shi, Kagawa, 765-8507, Japan
TEL
0877-62-1000
Homepage URL
volttt2000@gmail.com
Sponsor or person
Institute
Shikoku Medical Center for Children and Adults
Institute
Department
Personal name
Funding Source
Organization
Shikoku Medical Center for Children and Adults
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shikoku Medical Center for Children and Adults
Address
2-1-1, Senyu-cho, Zentsuji-shi, Kagawa, 765-8507, Japan
Tel
0877-62-1000
volttt2000@gmail.com
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
| 2020 | Year | 03 | Month | 03 | 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
No longer recruiting
Date of protocol fixation
| 2020 | Year | 01 | Month | 31 | Day |
Date of IRB
| 2020 | Year | 01 | Month | 31 | Day |
Anticipated trial start date
| 2020 | Year | 03 | Month | 03 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 03 | Month | 03 | Day |
Last modified on
| 2025 | Year | 03 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045257
