Early Administration of Bifidobacterium to Very Low Birth Weight Infants

NCT ID: NCT01330095

Last Updated: 2011-04-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2008-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Preterm Infants

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Eearly administration

Administration of Bifidobacterium within 48h after birth

Group Type ACTIVE_COMPARATOR

Administration of Bifidobacterium bifidum

Intervention Type DIETARY_SUPPLEMENT

Administration of Bifidobacterium bifidum to very low birth weight infants

Late administration

Administration of Bifidobacterium more than 48h after birth

Group Type ACTIVE_COMPARATOR

Administration of Bifidobacterium bifidum

Intervention Type DIETARY_SUPPLEMENT

Administration of Bifidobacterium bifidum to very low birth weight infants

Interventions

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Administration of Bifidobacterium bifidum

Administration of Bifidobacterium bifidum to very low birth weight infants

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Bifidobacterium bifidum OLB6378

Eligibility Criteria

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Inclusion Criteria

* Very low birth weight infant

Exclusion Criteria

* Presence of major congenital malformations
Maximum Eligible Age

7 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tokyo Women's Medical University

OTHER

Sponsor Role lead

Responsible Party

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Tokyo Women's Medical Center

Locations

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Tokyo Women's Medical Unversity

Shinjuku, Tokyo, Japan

Site Status

Countries

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Japan

References

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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.

Reference Type DERIVED
PMID: 22507386 (View on PubMed)

Other Identifiers

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UMIN000005245

Identifier Type: OTHER

Identifier Source: secondary_id

1016

Identifier Type: -

Identifier Source: org_study_id

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