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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000002543
Receipt No. R000003109
Scientific Title Effect of bifidbacterium bifidum supplementation on morbidity of very low birth weight infants
Date of disclosure of the study information 2010/01/01
Last modified on 2017/02/23

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Basic information
Public title Effect of bifidbacterium bifidum supplementation on morbidity of very low birth weight infants
Acronym bifidbacterium supplementation for very low birth weight infants
Scientific Title Effect of bifidbacterium bifidum supplementation on morbidity of very low birth weight infants
Scientific Title:Acronym bifidbacterium supplementation for very low birth weight infants
Region
Japan

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

Objectives
Narrative objectives1 acceleration of enteral feeging
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes day at enteral feeding over 100ml/kg/day
SD score of BW and HC atdischarge
Key secondary outcomes incidence of NEC or sepsis
Development at 1.5 and 2 years old
Intestinal flora(at birht, 1wk, and 1m)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Double blind -all involved are blinded
Control Placebo
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 supplementatioan of Bifidobacterium bifidum
Interventions/Control_2 placebo
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
0 weeks-old >
Gender Male and Female
Key inclusion criteria infants with birhtweight less than 1500g
Key exclusion criteria severe bacterila infection
congenital anomaly
not suitabel for the trial defined by the attending neonatologist
Target sample size 400

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Satoshi Kusuda
Organization Maternal and Perinatal Center,
Tokyo Women's Medical University
Division name Dept of Neonatology
Zip code
Address 8-1 Kawadacho, Shinjuku, Tolyo
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 Dept of Neonatology
Zip code
Address 8-1 Kawadacho, Shinjuku, Tokyo
TEL 03-5269-7344
Homepage URL http://plaza.umin.ac.jp/nrndata/
Email bifido@boshi.twmu.ac.jp

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

Funding Source
Organization Meiji Milk co.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Meiji Milk Co.
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 独立行政法人国立病院機構 長崎医療センター(長崎県)
茨城県立こども病院(茨城県)
福島県立医科大学医学部附属病院(福島県)
厚生連高岡病院(富山県)
東邦大学医療センター大森病院(東京都)
独立行政法人国立病院機構 福島病院(福島県)
岩手医科大学(岩手県)
津山中央病院(島根県)
島根県立中央病院(島根県)
川崎医科大学附属病院(岡山県)
岐阜県総合医療センター(岐阜県)
滋賀医科大学附属病院(滋賀県)
秋田赤十字病院(秋田県)
静岡済生会総合病院(静岡県)
新潟県立中央病院(新潟県)
宇治徳洲会病院(京都府)
長岡赤十字病院(新潟県)
信州大学医学部附属病院(長野県)
倉敷中央病院(岡山県)
名古屋市立城北病院(愛知県)
東京女子医科大学母子総合医療センター(東京都)

Other administrative information
Date of disclosure of the study information
2010 Year 01 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://onlinelibrary.wiley.com/doi/10.1111/ped.12330/epdf
Number of participants that the trial has enrolled
Results
A total of 291 VLBW infants were enrolled in the study, B group (n = 160) and P group (n = 131). Among them, 233 infants were established enteral feeding within 21 days after birth, and were received B.bifidum or Placebo until their body weight reached 2000g (119 and 114 infant respectively). There was a significant difference in the establishment of enteral feeding which was 11.0+-3.6 days in B group and 12.1+-3.8 days in P group, respectively (p<0.05). The growth of the infants during the stay in NICU was not different between the groups. However, the incidence of sepsis among all enrolled infants was significantly lower in B group (p<0.05). There was no difference in the incidence of other adverse outcomes.
B.bifidum administration to VLBW infants accelerated their enteral feeding after birth without increasing of adverse effects. 
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
2009 Year 08 Month 31 Day
Date of IRB
Anticipated trial start date
2010 Year 01 Month 01 Day
Last follow-up date
2012 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 09 Month 25 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=R000003109

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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