NCT01330095

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

April 1, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 6, 2011

Completed
Last Updated

April 6, 2011

Status Verified

December 1, 2008

Enrollment Period

1.3 years

First QC Date

April 1, 2011

Last Update Submit

April 5, 2011

Conditions

Preterm Infants

Keywords

Bifidobacterium bifidumVery low birth weight infantEnteral feedingGrowthamount of enteral feeding

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • colonizatin of Bifidobacterium

    4 weeks after birth

Study Arms (2)

Eearly administration

ACTIVE COMPARATOR

Administration of Bifidobacterium within 48h after birth

Dietary Supplement: Administration of Bifidobacterium bifidum

Late administration

ACTIVE COMPARATOR

Administration of Bifidobacterium more than 48h after birth

Dietary Supplement: Administration of Bifidobacterium bifidum

Interventions

Administration of Bifidobacterium bifidumDIETARY_SUPPLEMENT

Administration of Bifidobacterium bifidum to very low birth weight infants

Also known as: Bifidobacterium bifidum OLB6378
Eearly administrationLate administration

Eligibility Criteria

AgeUp to 7 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Very low birth weight infant

You may not qualify if:

  • Presence of major congenital malformations

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tokyo Women's Medical Unversity

Shinjuku, Tokyo, 162-8666, Japan

Location

Related Publications (1)

  • Yamasaki C, Totsu S, Uchiyama A, Nakanishi H, Masumoto K, Washio Y, Shuri K, Ishida S, Imai K, Kusuda S. Effect of Bifidobacterium administration on very-low-birthweight infants. Pediatr Int. 2012 Oct;54(5):651-6. doi: 10.1111/j.1442-200X.2012.03649.x. Epub 2012 Jul 10.

    PMID: 22507386DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 1, 2011

First Posted

April 6, 2011

Study Start

March 1, 2007

Primary Completion

June 1, 2008

Study Completion

December 1, 2008

Last Updated

April 6, 2011

Record last verified: 2008-12

Locations

JP(1)