Back to resultsEarly Administration of Bifidobacterium to Very Low Birth Weight Infants
Primary Purpose
Preterm Infants
Status
Completed
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
Administration of Bifidobacterium bifidum
Sponsored by
About this trial
This is an interventional supportive care trial for Preterm Infants focused on measuring Bifidobacterium bifidum, Very low birth weight infant, Enteral feeding, Growth, amount of enteral feeding
Eligibility Criteria
Inclusion Criteria:
- Very low birth weight infant
Exclusion Criteria:
- Presence of major congenital malformations
Sites / Locations
- Tokyo Women's Medical Unversity
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Eearly administration
Late administration
Arm Description
Administration of Bifidobacterium within 48h after birth
Administration of Bifidobacterium more than 48h after birth
Outcomes
Primary Outcome Measures
the day at total feeding volume reached 100ml/kg/day
the post natal day at total enteral feeding reached 100ml/kg/day
Secondary Outcome Measures
colonizatin of Bifidobacterium
the level of Bifidobacterium in feces from the study infants growth rate of the study infants the positive rate of MRSA colonization among the study infants adverse outcomes
Full Information
NCT ID
NCT01330095
First Posted
April 1, 2011
Last Updated
April 5, 2011
Sponsor
Tokyo Women's Medical University
1. Study Identification
Unique Protocol Identification Number
NCT01330095
Brief Title
Early Administration of Bifidobacterium to Very Low Birth Weight Infants
Official Title
Early Administration of Bifidobacterium Bifidum to Very Low Birth Weight Infants: A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
December 2008
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
December 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Tokyo Women's Medical University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To evaluate the effects of early administration of probiotics on acceleration of enteral feeding, and on growth of very low birth weight infants, newborn infants with birth weight less than 1500g are administered Bifidobacterium bifidum twice a day.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Infants
Keywords
Bifidobacterium bifidum, Very low birth weight infant, Enteral feeding, Growth, amount of enteral feeding
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Eearly administration
Arm Type
Active Comparator
Arm Description
Administration of Bifidobacterium within 48h after birth
Arm Title
Late administration
Arm Type
Active Comparator
Arm Description
Administration of Bifidobacterium more than 48h after birth
Intervention Type
Dietary Supplement
Intervention Name(s)
Administration of Bifidobacterium bifidum
Other Intervention Name(s)
Bifidobacterium bifidum OLB6378
Intervention Description
Administration of Bifidobacterium bifidum to very low birth weight infants
Primary Outcome Measure Information:
Title
the day at total feeding volume reached 100ml/kg/day
Description
the post natal day at total enteral feeding reached 100ml/kg/day
Time Frame
post natal day
Secondary Outcome Measure Information:
Title
colonizatin of Bifidobacterium
Description
the level of Bifidobacterium in feces from the study infants growth rate of the study infants the positive rate of MRSA colonization among the study infants adverse outcomes
Time Frame
4 weeks after birth
10. Eligibility
Sex
All
Maximum Age & Unit of Time
7 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Very low birth weight infant
Exclusion Criteria:
Presence of major congenital malformations
Facility Information:
Facility Name
Tokyo Women's Medical Unversity
City
Shinjuku
State/Province
Tokyo
ZIP/Postal Code
162-8666
Country
Japan
12. IPD Sharing Statement
Citations:
PubMed Identifier
22507386
Citation
Yamasaki C, Totsu S, Uchiyama A, Nakanishi H, Masumoto K, Washio Y, Shuri K, Ishida S, Imai K, Kusuda S. Effect of Bifidobacterium administration on very-low-birthweight infants. Pediatr Int. 2012 Oct;54(5):651-6. doi: 10.1111/j.1442-200X.2012.03649.x. Epub 2012 Jul 10.
Results Reference
derived
Learn more about this trial
Early Administration of Bifidobacterium to Very Low Birth Weight Infants
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