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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000025088
Receipt No. R000028830
Scientific Title Biotin supplement for very low birth weight infant
Date of disclosure of the study information 2017/01/01
Last modified on 2016/11/29

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Basic information
Public title Biotin supplement for very low birth weight infant
Acronym Biotin for very low birth weight infant
Scientific Title Biotin supplement for very low birth weight infant
Scientific Title:Acronym Biotin for very low birth weight infant
Region
Japan

Condition
Condition very low birth weight infant
Classification by specialty
Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We examine whether biotin supplementation is effective for late onset metabolic acidosis of very low birth weight infant.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase III

Assessment
Primary outcomes late onset metabolic acidosis for 3-8 weeks of age
Key secondary outcomes mortality at discharge
neurological morbidity at the age of two years

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 oral supplementation of biotin 0.5mg once a day from the third day of life to the day of discharge
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
3 days-old <
Age-upper limit
7 days-old >
Gender Male and Female
Key inclusion criteria very low birth weight infants born at our hospital
Key exclusion criteria congenital malformation syndrome
abnormalities of chromosome
Target sample size 150

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shoji Kagami
Organization Tokushima University Hospital
Division name Pediatrics
Zip code
Address Kuramoto-cho 2chome , Tokushima
TEL +81-88-633-9555
Email kagami@tokushima-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kenichi Suga
Organization Tokushima University Hospital
Division name Pediatrics
Zip code
Address Kuramoto-cho 2chome , Tokushima
TEL +81-88-633-9555
Homepage URL
Email suga.kenichi.1@tokushima-u.ac.jp

Sponsor
Institute Ministry of Health, Labour and Welfare
Institute
Department

Funding Source
Organization no funding source
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
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

Other administrative information
Date of disclosure of the study information
2017 Year 01 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
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 Preinitiation
Date of protocol fixation
2016 Year 12 Month 26 Day
Date of IRB
Anticipated trial start date
2017 Year 01 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 11 Month 30 Day
Last modified on
2016 Year 11 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028830

Research Plan
Registered date File name
2017/11/30 ビオチン投与 研究計画 .pdf

Research case data specifications
Registered date File name

Research case data
Registered date File name


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