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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000025294
Receipt No. R000029094
Scientific Title Evaluation of safety and efficacy of parental Fish oil for intestinal failure associated liver disease
Date of disclosure of the study information 2016/12/15
Last modified on 2016/12/15

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Basic information
Public title Evaluation of safety and efficacy of parental Fish oil for intestinal failure associated liver disease
Acronym Evaluation of safety and efficacy of parental Fish oil for intestinal failure associated liver disease
Scientific Title Evaluation of safety and efficacy of parental Fish oil for intestinal failure associated liver disease
Scientific Title:Acronym Evaluation of safety and efficacy of parental Fish oil for intestinal failure associated liver disease
Region
Japan

Condition
Condition intestinal failure associated liver disease
parental nutrition associated cholestasis
Classification by specialty
Gastroenterology Hepato-biliary-pancreatic medicine Gastrointestinal surgery
Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 to determine safety and efficacy of parental fish oil for
infants at risk of or with intestinal failure associated liver disease and parental nutrition associated cholestasis
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes improvement of liver function test
Key secondary outcomes mortality
withdrawal from parental nutrition
physical growth
needs of liver transplantation

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 parenteral administration of parental fish oil
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. infants who admitted to our NICU
2. infants at risk of Intestinal failure associated liver disease and parenteral nutrition associated cholestasis
3. infants with Intestinal failure associated liver disease and parenteral nutrition associated cholestasis
Key exclusion criteria 1. Refusal of informed consent
Target sample size 15

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Sumie Fujinuma
Organization Saitama Medical Center, Saitama Medical University
Division name Department of Pediatrics
Zip code
Address 1981 kamoda, Kawagoe, Saitama, Japan
TEL +81-49-228-3725
Email sahrau1112@hotmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Sumie Fujinuma
Organization Saitama Medical Center, Saitama Medical University
Division name Department of Pediatrics
Zip code
Address 1981 kamoda, Kawagoe, Saitama, Japan
TEL +81-49-228-3725
Homepage URL
Email sahrau1112@hotmail.com

Sponsor
Institute Saitama Medical Center, Saitama Medical University
Institute
Department

Funding Source
Organization Saitama Medical Center, Saitama Medical University
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 埼玉医科大学総合医療センター(埼玉県)

Other administrative information
Date of disclosure of the study information
2016 Year 12 Month 15 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 15 Day
Date of IRB
Anticipated trial start date
2016 Year 12 Month 15 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 12 Month 15 Day
Last modified on
2016 Year 12 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029094

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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