UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000002543
Receipt number 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 11:54:38

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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 or person

Institute

Maternal and Perinatal Center,
Tokyo Women's Medical University

Institute

Department

Personal name



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

Value
https://center6.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