UMIN-CTR Clinical Trial

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

very low birth weight infant

Classification by specialty

Pediatrics

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

acceleration of enteral feeging

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

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)

Study type

Interventional

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

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

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

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

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

Institute

Maternal and Perinatal Center,
Tokyo Women's Medical University

Institute

Department

Personal name

Organization

Meiji Milk co.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan

Co-sponsor

Meiji Milk Co.

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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）

Date of disclosure of the study information

2010

Year

01

Month

01

Day

URL releasing protocol

Publication of results

Published

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

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 related 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