Bifidobacterium Supplementation for Very Low Birth Weight Infants

NCT01375309 | Completed DMC

• 2 other identifiers: 1675UMIN000002543
• Study Type: interventional
• Target: 246
• Locations: 1 country
• Sites: 1

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.

Conditions

Preterm Infants

Keywords

probiotics; preterm infants; enteral feeding; Bifidobacterium on enteral feeding

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• standard deviation(SD) scores of bodyweight(BW) and head circumference(HC)

  For the duration of NICU stay, an expected average of 3 months

• Necrotizing enterocolitis or sepsis

  For the duration of NICU stay, an expected average of 3 months

• Intestinal flora

  For the duration of NICU stay, an expected average of 3 months

Study Arms (2)

Active

ACTIVE COMPARATOR

Bifidobacterium bifidum

Dietary Supplement: Bifidobacterium bifidum supplementation

Placebo

PLACEBO COMPARATOR

Dextrin without Bifidobacterium bifidum

Dietary Supplement: Placebo contains dextrin

Interventions

Bifidobacterium bifidum supplementation DIETARY_SUPPLEMENT

Bifidobacterium bifidum supplementation wiht approximately 2.5\*10to9th bacteria per day

Also known as: Bifidobacterium bifidum OLB6378

Active

Placebo contains dextrin DIETARY_SUPPLEMENT

0.5 of dextrin

Placebo

Eligibility Criteria

• Age: Up to 48 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Infants with birth weight less than 1500g

You may not qualify if:

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

Sponsors & Collaborators

• Tokyo Women's Medical University: lead

Study Sites (1)

Tokyo Women's Medical Unversity

Shinjuku, Tokyo, 162-8666, Japan

Location

Related Publications (2)

• Sharif S, Meader N, Oddie SJ, Rojas-Reyes MX, McGuire W. Probiotics to prevent necrotising enterocolitis in very preterm or very low birth weight infants. Cochrane Database Syst Rev. 2023 Jul 26;7(7):CD005496. doi: 10.1002/14651858.CD005496.pub6.

  PMID: 37493095 DERIVED

• Sharif S, Meader N, Oddie SJ, Rojas-Reyes MX, McGuire W. Probiotics to prevent necrotising enterocolitis in very preterm or very low birth weight infants. Cochrane Database Syst Rev. 2020 Oct 15;10(10):CD005496. doi: 10.1002/14651858.CD005496.pub5.

  PMID: 33058137 DERIVED

Study Officials

• Satoshi Kusuda, MD

  Tokyo Women's Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Neonatology

Study Record Dates

• First Submitted: June 6, 2011
• First Posted: June 17, 2011
• Study Start: January 1, 2010
• Primary Completion: June 1, 2011
• Study Completion: December 1, 2011
• Last Updated: March 30, 2012

Record last verified: 2012-03

Locations

JP (1)