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Early Administration of Bifidobacterium to Very Low Birth Weight Infants

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ClinicalTrials.gov Identifier: NCT01330095
Recruitment Status : Completed
First Posted : April 6, 2011
Last Update Posted : April 6, 2011
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Preterm Infants Dietary Supplement: Administration of Bifidobacterium bifidum Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Early Administration of Bifidobacterium Bifidum to Very Low Birth Weight Infants: A Pilot Study
Study Start Date : March 2007
Actual Primary Completion Date : June 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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 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



Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   up to 7 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Very low birth weight infant

Exclusion Criteria:

  • Presence of major congenital malformations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01330095


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

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 ( Other Identifier: University hospital Medical Information Network )
First Posted: April 6, 2011    Key Record Dates
Last Update Posted: April 6, 2011
Last Verified: December 2008

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