Bifidobacterium Supplementation for Very Low Birth Weight Infants

Preterm Infants Clinical Trial

— Bifido(RCT)  

Official title:

Effect of Bifidobacterium Bifidum Supplementation on Morbidity of Very Low Birth Weight Infants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01375309
• Other study ID #: 1675
• Secondary ID: UMIN000002543
• Status: Completed
• Phase: N/A
• First received: June 6, 2011
• Last updated: March 28, 2012
• Start date: January 2010
• Est. completion date: December 2011

Study information

• Verified date: March 2012
• Source: Tokyo Women's Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 246
• Est. completion date: December 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 48 Hours

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Birth Weight
• Preterm Infants

Intervention

Dietary Supplement:
• Bifidobacterium bifidum supplementation
Bifidobacterium bifidum supplementation wiht approximately 2.5*10to9th bacteria per day
• Placebo contains dextrin
0.5 of dextrin

Locations

Country	Name	City	State
Japan	Tokyo Women's Medical Unversity	Shinjuku	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Tokyo Women's Medical University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postnatal day when enteral feeding exceeded at 100ml/kg/day	Death or unsuccessful of establishing enteral feeding exceeded at 100ml/kg/day before day 28 of age is considered failure to reach primary endpoint.	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	No
Secondary	standard deviation(SD) scores of bodyweight(BW) and head circumference(HC)	BW gain/day, SD scores of BW and HC at discharge from NICU	For the duration of NICU stay, an expected average of 3 months	No
Secondary	Necrotizing enterocolitis or sepsis	The incidences of necrtizing enterocolitis or sepsis during the stay in NICU	For the duration of NICU stay, an expected average of 3 months	Yes
Secondary	Intestinal flora	Intestinal flora during the stay in NICU	For the duration of NICU stay, an expected average of 3 months	No