Early Administration of Bifidobacterium to Very Low Birth Weight Infants

Preterm Infants Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01330095
• Other study ID #: 1016
• Secondary ID: UMIN000005245
• Status: Completed
• Phase: N/A
• First received: April 1, 2011
• Last updated: April 5, 2011
• Start date: March 2007
• Est. completion date: December 2008

Study information

• Verified date: December 2008
• Source: Tokyo Women's Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: University hospital Medical Information Network
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: December 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 7 Days

Eligibility

Inclusion Criteria:

• Very low birth weight infant

Exclusion Criteria:

• Presence of major congenital malformations

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Birth Weight
• Preterm Infants

Intervention

Dietary Supplement:
• Administration of Bifidobacterium bifidum
Administration of Bifidobacterium bifidum to very low birth weight infants

Locations

Country	Name	City	State
Japan	Tokyo Women's Medical Unversity	Shinjuku	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Tokyo Women's Medical University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the day at total feeding volume reached 100ml/kg/day	the post natal day at total enteral feeding reached 100ml/kg/day	post natal day	No
Secondary	colonizatin of Bifidobacterium	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	Yes