UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024352 |
|---|---|
| Receipt number | 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 | 2023/10/19 10:16:36 |
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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
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
khoriba@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Graduate School of Medicine
Department of Pediatrics
Institute
Department
Personal name
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
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
120
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
| 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
| 2023 | Year | 10 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027328
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| Registered date | File name |
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