UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005245 |
|---|---|
| Receipt number | 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 11:55:49 |
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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
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
kusuda-satoshi@umin.ac.jp
Sponsor or person
Institute
Maternal and Perinatal Center,
Tokyo Women's Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006237
| Research Plan | |
|---|---|
| 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 |
