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Recruitment status Main results already published
Unique ID issued by UMIN UMIN000005245
Receipt No. R000006237
Scientific Title Early administration of Bifidobacterium bifidum to very low birth weight infants: A Pilot Study
Date of disclosure of the study information 2011/03/14
Last modified on 2017/02/23

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Basic information
Public title Early administration of Bifidobacterium bifidum to very low birth weight infants: A Pilot Study
Acronym Early administration of Bifidobacterium to very low birth weight infants
Scientific Title Early administration of Bifidobacterium bifidum to very low birth weight infants: A Pilot Study
Scientific Title:Acronym Early administration of Bifidobacterium to very low birth weight infants
Region
Japan

Condition
Condition Very low birht weight infants
Classification by specialty
Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the effects of early administration of Bifidobacterium bifidum on acceleration of enteral feeding, and on growth of very low birth weight infants.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes the day at total feeding volume reached 100ml/kg/day
Key secondary outcomes the level of Bifidobacterium in feces from the study infants
growth rate of the study infants
the positive rate of MRSA colonization among the study infants

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Administration of Bifidobacterium within 48h after birth
Interventions/Control_2 Administration of Bifidobacterium more than 48h after birth
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
1 weeks-old >
Gender Male and Female
Key inclusion criteria newborn infants with birth weight less than 1500 g
Key exclusion criteria presence of major congenital malformations
serious infection
lack of parental consent.
Target sample size 36

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Satoshi Kusuda
Organization Tokyo Women's Medical University
Division name Maternal and Perinatal Center
Zip code
Address 8-1 Kawadacho, Shinjuku, Tokyo
TEL 03-5269-7344
Email kusuda-satoshi@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Satoshi Kusuda
Organization Tokyo Women's Medical University
Division name Neonatology
Zip code
Address 8-1 Kawadacho, Shinjuku, Tokyo
TEL 03-5269-7344
Homepage URL
Email kusuda-satoshi@umin.ac.jp

Sponsor
Institute Maternal and Perinatal Center,
Tokyo Women's Medical University
Institute
Department

Funding Source
Organization Maternal and Perinatal Center,
Tokyo Women's Medical University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization none

Other related organizations
Co-sponsor Meiji Dairies Corporation
Name of secondary funder(s) none

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 Tokyo Women's Medical University

Other administrative information
Date of disclosure of the study information
2011 Year 03 Month 14 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://authorservices.wiley.com/bauthor/terms.asp?ArticleID=997233&auid=
Number of participants that the trial has enrolled
Results
There was no difference in the day total feeding volume reached 100ml/kg/day and the level of Bifidobacterium in feces between the groups. The body weight at discharge tended to be heavier in the eary administration group.
The body weight gain per day during hospitalization in the early adminstration group was higher than that of the control group.
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 Main results already published
Date of protocol fixation
2006 Year 12 Month 31 Day
Date of IRB
Anticipated trial start date
2007 Year 03 Month 01 Day
Last follow-up date
2008 Year 12 Month 01 Day
Date of closure to data entry
2008 Year 12 Month 01 Day
Date trial data considered complete
2008 Year 12 Month 01 Day
Date analysis concluded
2008 Year 12 Month 01 Day

Other
Other related information No side effect was observed.

Management information
Registered date
2011 Year 03 Month 14 Day
Last modified on
2017 Year 02 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006237

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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