NCT01330095CompletedNot Applicable
Early Administration of Bifidobacterium Bifidum to Very Low Birth Weight Infants: A Pilot Study
Tokyo Women's Medical University2 sites in 1 country36 target enrollmentStarted: March 2007Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 36
- Locations
- 2
- Primary Endpoint
- the day at total feeding volume reached 100ml/kg/day
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- — to 7 Days (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Very low birth weight infant
Exclusion Criteria
- •Presence of major congenital malformations
Outcomes
Primary Outcomes
the day at total feeding volume reached 100ml/kg/day
Time Frame: post natal day
the post natal day at total enteral feeding reached 100ml/kg/day
Secondary Outcomes
- colonizatin of Bifidobacterium(4 weeks after birth)
Investigators
Study Sites (2)
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