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Early Administration of Bifidobacterium to Very Low Birth Weight Infants

This study has been completed.
Sponsor:
Information provided by:
Tokyo Women's Medical University
ClinicalTrials.gov Identifier:
NCT01330095
First received: April 1, 2011
Last updated: April 5, 2011
Last verified: December 2008
History of Changes
  Purpose

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.


Condition Intervention
Preterm Infants
 Dietary Supplement: Administration of Bifidobacterium bifidum

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Early Administration of Bifidobacterium Bifidum to Very Low Birth Weight Infants: A Pilot Study

Resource links provided by NLM:

MedlinePlus related topics: Birth Weight
U.S. FDA Resources

Further study details as provided by Tokyo Women's Medical University:

Primary Outcome Measures:
  • the day at total feeding volume reached 100ml/kg/day [ Time Frame: post natal day ] [ Designated as safety issue: No ]
    the post natal day at total enteral feeding reached 100ml/kg/day


Secondary Outcome Measures:
  • colonizatin of Bifidobacterium [ Time Frame: 4 weeks after birth ] [ Designated as safety issue: Yes ]
    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


Enrollment: 36
Study Start Date: March 2007
Study Completion Date: December 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Bifidobacterium bifidum OLB6378

  Eligibility

Ages Eligible for Study:   up to 7 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Very low birth weight infant

Exclusion Criteria:

  • Presence of major congenital malformations
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01330095

Locations
Japan
Tokyo Women's Medical Unversity
Shinjuku, Tokyo, Japan, 162-8666
Sponsors and Collaborators
Tokyo Women's Medical University
  More Information

No publications provided by Tokyo Women's Medical University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Satoshi Kusuda, Tokyo Women's Medical Center
ClinicalTrials.gov Identifier: NCT01330095     History of Changes
Other Study ID Numbers: 1016, UMIN000005245
Study First Received: April 1, 2011
Last Updated: April 5, 2011
Health Authority: Japan: University hospital Medical Information Network

Keywords provided by Tokyo Women's Medical University:
Bifidobacterium bifidum
Very low birth weight infant
Enteral feeding
Growth
amount of enteral feeding

Additional relevant MeSH terms:
Birth Weight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 22, 2013