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Early Administration of Bifidobacterium to Very Low Birth Weight Infants

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01330095
Enrollment
36
Registered
2011-04-06
Start date
2007-03-31
Completion date
2008-12-31
Last updated
2011-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preterm Infants

Keywords

Bifidobacterium bifidum, Very low birth weight infant, Enteral feeding, Growth, amount of enteral feeding

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.

Interventions

DIETARY_SUPPLEMENTAdministration of Bifidobacterium bifidum

Administration of Bifidobacterium bifidum to very low birth weight infants

Sponsors

Tokyo Women's Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
No minimum to 7 Days
Healthy volunteers
No

Inclusion criteria

* Very low birth weight infant

Exclusion criteria

* Presence of major congenital malformations

Design outcomes

Primary

MeasureTime frameDescription
the day at total feeding volume reached 100ml/kg/daypost natal daythe post natal day at total enteral feeding reached 100ml/kg/day

Secondary

MeasureTime frameDescription
colonizatin of Bifidobacterium4 weeks after birththe 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

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026