Bifidobacterium Supplementation for Very Low Birth Weight Infants

Not Applicable

Completed

• Conditions: Preterm Infants
• Interventions: Dietary Supplement: Bifidobacterium bifidum supplementation; Dietary Supplement: Placebo contains dextrin

• Registration Number: NCT01375309
• Lead Sponsor: Tokyo Women's Medical University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Primary Completion: 2011-06
• Study First Submitted: 2011-06-06
• Study First Submitted QC: 2011-06-16
• Study First Posted: 2011-06-17
• Study Completion: 2011-12
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-28
• Last Update Posted: 2012-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 246

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active	Bifidobacterium bifidum supplementation	Bifidobacterium bifidum
Placebo	Placebo contains dextrin	Dextrin without Bifidobacterium bifidum

Primary Outcome Measures

Name	Time	Method
Postnatal day when enteral feeding exceeded at 100ml/kg/day	From birth untill the date of enteral feeding first exceeded at 100ml/kg/day or date of death from any cause, whichever came first, assesed up to 27 days after birth	Death or unsuccessful of establishing enteral feeding exceeded at 100ml/kg/day before day 28 of age is considered failure to reach primary endpoint.

Secondary Outcome Measures

Name	Time	Method
standard deviation(SD) scores of bodyweight(BW) and head circumference(HC)	For the duration of NICU stay, an expected average of 3 months	BW gain/day, SD scores of BW and HC at discharge from NICU
Necrotizing enterocolitis or sepsis	For the duration of NICU stay, an expected average of 3 months	The incidences of necrtizing enterocolitis or sepsis during the stay in NICU
Intestinal flora	For the duration of NICU stay, an expected average of 3 months	Intestinal flora during the stay in NICU

Trial Locations

Locations (1)

Tokyo Women's Medical Unversity; 🇯🇵 Shinjuku, Tokyo, Japan