UMIN-CTR Clinical Trial

Basic information
Public title	Effect of enteral feeding by formula which contains Bifidobacteria in low birth weight infants
Acronym	Bifidobacteria/LW study
Scientific Title	Effect of enteral feeding by formula which contains Bifidobacteria in low birth weight infants
Scientific Title:Acronym	Bifidobacteria/LW study
Region	Japan

Condition
Condition	Low birth weight infants
Classification by specialty	Pediatrics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Evaluate the acceleration effect of enteral feeding and safety by formula which contains Bifidobacteria for LBWI
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	establishment of enteral feeding,defined as the postnatal day at which the amount of enteral feeding exceeded 100ml/kg/day
Key secondary outcomes	Growth(length,bodyweight, head circumference) Blood examination(calcium, phosphorus,ALP,iron,albumin,BUN,Hb) Morbidity(ricket,ROP,infection,anemin,NEC,CLD,PVL)

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	The infants receive either breast milk or premature formula which contains Bifidobacteria(test formula) if the mothers have inadequate milk production. The administration of test formula to each infant is continued until the body weight reached 2,000g.
Interventions/Control_2
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	0 years-old <=
Age-upper limit	0 years-old >=
Gender	Male and Female
Key inclusion criteria	LBWI(birthweight:>=1,000g and <2,000g, gestational age:>=28weeks) who is born in Toho university Ohmori medical center Parents receive enough information and consent to participate this trial
Key exclusion criteria	Who have sever respiratory ,renal ,cardiac or metabolic disease Who have chromosomal disease, congenital malformations Lack of parental consent Who are desided inappropriate to participate this trial
Target sample size	45

Research contact person
Name of lead principal investigator	1st name Hiroko Middle name Last name Arai
Organization	Toho University Ohmori Medical Center
Division name	Department of Neonatology
Zip code	143-8541
Address	6-11-1,Ohmori-Nishi,Ohta-ku,Tokyo 143-8541,Japan
TEL	03-3762-4151
Email	araihiro@med.toho-u.ac.jp

Public contact
Name of contact person	1st name Hiroko Middle name Last name Arai
Organization	Toho University Ohmori Medical Center
Division name	Department of Neonatology
Zip code	143-8541
Address	6-11-1,Ohmori-Nishi,Ohta-ku,Tokyo 143-8541,Japan
TEL	03-3762-4151
Homepage URL
Email	araihiro@med.toho-u.ac.jp

Sponsor
Institute	Toho University Ohmori Medical Center Department of Neonatology
Institute
Department

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

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Toho University Omori Medical Center
Address	6-11-1,Ohmori-Nishi,Ohta-ku,Tokyo 143-8541,Japan
Tel	0337624151
Email	araihiro@med.toho-u.ac.jp

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	東邦大学医療センター大森病院

Other administrative information
Date of disclosure of the study information	2019 Year 12 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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	2016 Year 07 Month 29 Day
Date of IRB	2016 Year 09 Month 28 Day
Anticipated trial start date	2016 Year 10 Month 24 Day
Last follow-up date	2018 Year 11 Month 30 Day
Date of closure to data entry	2019 Year 05 Month 31 Day
Date trial data considered complete	2019 Year 05 Month 31 Day
Date analysis concluded	2019 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date	2016 Year 10 Month 14 Day
Last modified on	2020 Year 03 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000028010