UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021057 |
|---|---|
| Receipt number | R000023986 |
| Scientific Title | A prospective, multicenter, observational study: validity of modified treatment strategy for neonatal jaundice in Japan |
| Date of disclosure of the study information | 2016/04/01 |
| Last modified on | 2020/06/23 15:56:26 |
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Basic information
Public title
A prospective, multicenter, observational study: validity of modified treatment strategy for neonatal jaundice in Japan
Acronym
Validity of modified treatment strategy for neonatal jaundice
Scientific Title
A prospective, multicenter, observational study: validity of modified treatment strategy for neonatal jaundice in Japan
Scientific Title:Acronym
Validity of modified treatment strategy for neonatal jaundice
Region
| Japan |
Condition
Condition
neonatal jaundice
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the validity of modified treatment strategy for neonatal jaundice
Basic objectives2
Others
Basic objectives -Others
To clarify the duration of phototherapy and the rate of exchange transfusion in newborn period, and the rate of kernicterus and neurodevelopment mobidity at 18 months corrected age
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
The rate of kernicterus and neurodevelopmental mobidity at 18 months corrected age
Key secondary outcomes
The duration of phototherapy and the rate of exchange transfusion
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 1 | days-old | <= |
Age-upper limit
| 540 | days-old | > |
Gender
Male and Female
Key inclusion criteria
newborns treated for neonatal jaundice during study period
Key exclusion criteria
patients without consent from parents
Target sample size
6000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ichiro Morioka |
Organization
Kobe University
Division name
Department of pediatrics
Zip code
Address
7-5-2, Kusunoki-cho, Chuo-ku, Kobe
TEL
81-78-382-6090
ichim@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ichiro Morioka |
Organization
Kobe University
Division name
Department of pediatrics
Zip code
Address
7-5-2, Kusunoki-cho, Chuo-ku, Kobe
TEL
81-78-382-6090
Homepage URL
ichim@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University
Institute
Department
Personal name
Funding Source
Organization
Japan society for the promotion of science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
神戸大学医学部附属病院（兵庫県）、日本大学板橋病院小児科（東京）、香川大学病院（香川県）、加古川西市民病院（兵庫県）、兵庫県立こども病院（兵庫県）、姫路赤十字病院（兵庫県）、愛仁会高槻病院（大阪府）、愛仁会千船病院（大阪府）、済生会兵庫県病院（兵庫県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 04 | Month | 01 | 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
under study
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
| 2015 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 11 | Month | 17 | Day |
Anticipated trial start date
| 2015 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2021 | Year | 03 | Month | 31 | Day |
Other
Other related information
Study design: Cohort study
Enrollment: Preterm infants admitted in our NICUs between April 2015 to March 2020, who fulfilled our inclusion criteria
Major outcome: The rate of kernicterus and neurodevelopmental mobidity at 18 months corrected age (Head MRI, Audiotory brainstem response)
Management information
Registered date
| 2016 | Year | 02 | Month | 16 | Day |
Last modified on
| 2020 | Year | 06 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023986
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
