UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024408 |
|---|---|
| Receipt number | R000028010 |
| Scientific Title | Effect of enteral feeding by formula which contains Bifidobacteria in low birth weight infants |
| Date of disclosure of the study information | 2019/12/31 |
| Last modified on | 2020/03/03 10:11:44 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
araihiro@med.toho-u.ac.jp
Sponsor or person
Institute
Toho University Ohmori Medical Center
Department of Neonatology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028010
