UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of bifidbacterium bifidum supplementation on morbidity of very low birth weight infants
Title of the study (Brief title)	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	Satoshi Kusuda
Organization	Maternal and Perinatal Center, Tokyo Women's Medical University
Division name	Dept of Neonatology
Address	8-1 Kawadacho, Shinjuku, Tolyo
TEL	03-5269-7344
Email	kusuda-satoshi@umin.ac.jp

Public contact
Name of contact person	Satoshi Kusuda
Organization	Tokyo Women's Medical University
Division name	Dept of Neonatology
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)

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

Progress
Recruitment status	Main results already published
Date of protocol fixation	2009 Year 08 Month 31 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	http://onlinelibrary.wiley.com/doi/10.1111/ped.12330/epdf
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.
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/icdr_e/ctr_view.cgi?recptno=R000003109