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OpenTrials
Completed

NCT Number: NCT01330095

Early Administration of Bifidobacterium to Very Low Birth Weight Infants

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.

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Key information

Conditions

Preterm Infants

Age range

Up to 7 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tokyo Women's Medical Unversity

Shinjuku, Tokyo, 162-8666, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Very low birth weight infant

Exclusion criteria

  • Presence of major congenital malformations

Treatment and study plan

Administration of Bifidobacterium bifidum

Dietary Supplement

Administration of Bifidobacterium bifidum to very low birth weight infants

Other names: Bifidobacterium bifidum OLB6378

Primary outcomes

  1. 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

  1. colonizatin of Bifidobacterium

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Tokyo Women's Medical University

Other

Registry information

Official study title

Early Administration of Bifidobacterium Bifidum to Very Low Birth Weight Infants: A Pilot Study

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Apr 6, 2011
Registry last updated
Apr 6, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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