Bifidobacterium Supplementation for Very Low Birth Weight Infants (Bifido(RCT))

Tokyo Women's Medical University

Status: Completed

Conditions: Preterm Infants

Treatments: Dietary Supplement: Placebo contains dextrin; Dietary Supplement: Bifidobacterium bifidum supplementation

Study type: Interventional

Funder types: Other

Identifiers

NCT01375309

UMIN000002543 (Other Identifier)

1675

Details and patient eligibility

About

Probiotic supplementation to preterm infants have been reported to be beneficial in neonatal intensive care unit (NICU). Our pilot study also showed accelerated feeding in preterm infants who received Bifidobacterium bifidum early after birth. In order to evaluate these beneficial effects of Bifidobacterium bifidum, a prospective randomized control study is conducted. The hypothesis of the study is that Bifidobacterium bifidum supplementation to preterm infants improve enteral feeding and growth in very low birth weight infants.

Enrollment: 246 patients

Sex: All

Ages: Under 48 hours old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Infants with birth weight less than 1500g

Exclusion criteria

• Sever bacteremia
• Congenital anomaly
• Not suitable for the trial defined by an attending neonatologist

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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246 participants in 2 patient groups, including a placebo group

Active

Active Comparator group

Description:

Bifidobacterium bifidum

Treatment:

Dietary Supplement: Bifidobacterium bifidum supplementation

Placebo

Placebo Comparator group

Description:

Dextrin without Bifidobacterium bifidum

Treatment:

Dietary Supplement: Placebo contains dextrin