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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000021057
Receipt No. 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

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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
Email 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
Email ichim@med.kobe-u.ac.jp

Sponsor
Institute Kobe University
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023986

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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