Early Administration of Bifidobacterium to Very Low Birth Weight Infants

April 5, 2011 updated by: Tokyo Women's Medical University

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Tokyo
      • Shinjuku, Tokyo, Japan, 162-8666
        • Tokyo Women's Medical Unversity

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 1 week (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Very low birth weight infant

Exclusion Criteria:

  • Presence of major congenital malformations

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Eearly administration
Administration of Bifidobacterium within 48h after birth
Dietary supplement: Administration of Bifidobacterium bifidum
Administration of Bifidobacterium bifidum to very low birth weight infants
Other Names:
  • Bifidobacterium bifidum OLB6378
ACTIVE_COMPARATOR: Late administration
Administration of Bifidobacterium more than 48h after birth
Dietary supplement: Administration of Bifidobacterium bifidum
Administration of Bifidobacterium bifidum to very low birth weight infants
Other Names:
  • Bifidobacterium bifidum OLB6378

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
post natal day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
4 weeks after birth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tokyo Women's Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Primary Completion (ACTUAL)

June 1, 2008

Study Completion (ACTUAL)

December 1, 2008

Study Registration Dates

First Submitted

April 1, 2011

First Submitted That Met QC Criteria

April 5, 2011

First Posted (ESTIMATE)

April 6, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

April 6, 2011

Last Update Submitted That Met QC Criteria

April 5, 2011

Last Verified

December 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1016
  • UMIN000005245 (OTHER: University hospital Medical Information Network)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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