Early Administration of Bifidobacterium to Very Low Birth Weight Infants

Not Applicable

Completed

• Conditions: Preterm Infants
• Interventions: Dietary Supplement: Administration of Bifidobacterium bifidum

• Registration Number: NCT01330095
• Lead Sponsor: Tokyo Women's Medical University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-03
• Primary Completion: 2008-06
• Status Verified: 2008-12
• Study Completion: 2008-12
• Study First Submitted: 2011-04-01
• Study First Submitted QC: 2011-04-05
• Last Update Submitted: 2011-04-05
• Study First Posted: 2011-04-06
• Last Update Posted: 2011-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• Very low birth weight infant

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Exclusion Criteria

• Presence of major congenital malformations

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Eearly administration	Administration of Bifidobacterium bifidum	Administration of Bifidobacterium within 48h after birth
Late administration	Administration of Bifidobacterium bifidum	Administration of Bifidobacterium more than 48h after birth

Primary Outcome Measures

Name	Time	Method
the day at total feeding volume reached 100ml/kg/day	post natal day	the post natal day at total enteral feeding reached 100ml/kg/day

Secondary Outcome Measures

Name	Time	Method
colonizatin of Bifidobacterium	4 weeks after birth	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

Trial Locations

Locations (1)

Tokyo Women's Medical Unversity; 🇯🇵 Shinjuku, Tokyo, Japan