Early Administration of Bifidobacterium to Very Low Birth Weight Infants

Tokyo Women's Medical University

Status: Completed

Conditions: Preterm Infants

Treatments: Dietary Supplement: Administration of Bifidobacterium bifidum

Study type: Interventional

Funder types: Other

Identifiers

NCT01330095

1016

UMIN000005245 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 36 patients

Sex: All

Ages: Under 7 days old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Very low birth weight infant

Exclusion criteria

• Presence of major congenital malformations

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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36 participants in 2 patient groups

Eearly administration

Active Comparator group

Description:

Administration of Bifidobacterium within 48h after birth

Treatment:

Dietary Supplement: Administration of Bifidobacterium bifidum

Late administration

Active Comparator group

Description:

Administration of Bifidobacterium more than 48h after birth

Treatment:

Dietary Supplement: Administration of Bifidobacterium bifidum