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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Satoshi Kusuda, Tokyo Women's Medical University
ClinicalTrials.gov Identifier:
NCT01375309
First received: June 6, 2011
Last updated: March 28, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention
Preterm Infants
Dietary Supplement: Bifidobacterium bifidum supplementation
Dietary Supplement: Placebo contains dextrin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Bifidobacterium Bifidum Supplementation on Morbidity of Very Low Birth Weight Infants

Resource links provided by NLM:


Further study details as provided by Tokyo Women's Medical University:

Primary Outcome Measures:
  • Postnatal day when enteral feeding exceeded at 100ml/kg/day [ Time Frame: 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 ] [ Designated as safety issue: No ]
    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:
  • standard deviation(SD) scores of bodyweight(BW) and head circumference(HC) [ Time Frame: For the duration of NICU stay, an expected average of 3 months ] [ Designated as safety issue: No ]
    BW gain/day, SD scores of BW and HC at discharge from NICU

  • Necrotizing enterocolitis or sepsis [ Time Frame: For the duration of NICU stay, an expected average of 3 months ] [ Designated as safety issue: Yes ]
    The incidences of necrtizing enterocolitis or sepsis during the stay in NICU

  • Intestinal flora [ Time Frame: For the duration of NICU stay, an expected average of 3 months ] [ Designated as safety issue: No ]
    Intestinal flora during the stay in NICU


Enrollment: 246
Study Start Date: January 2010
Study Completion Date: December 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Active
Bifidobacterium bifidum
Dietary Supplement: Bifidobacterium bifidum supplementation
Bifidobacterium bifidum supplementation wiht approximately 2.5*10to9th bacteria per day
Other Name: Bifidobacterium bifidum OLB6378
Placebo Comparator: Placebo
Dextrin without Bifidobacterium bifidum
Dietary Supplement: Placebo contains dextrin
0.5 of dextrin

  Eligibility

Ages Eligible for Study:   up to 48 Hours
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01375309

Locations
Japan
Tokyo Women's Medical Unversity
Shinjuku, Tokyo, Japan, 162-8666
Sponsors and Collaborators
Tokyo Women's Medical University
Investigators
Principal Investigator: Satoshi Kusuda, MD Tokyo Women's Medical University
  More Information

No publications provided

Responsible Party: Satoshi Kusuda, Professor of Neonatology, Tokyo Women's Medical University
ClinicalTrials.gov Identifier: NCT01375309     History of Changes
Other Study ID Numbers: 1675, UMIN000002543
Study First Received: June 6, 2011
Last Updated: March 28, 2012
Health Authority: Japan: Institutional Review Board

Keywords provided by Tokyo Women's Medical University:
probiotics
preterm infants
enteral feeding
Bifidobacterium on enteral feeding

Additional relevant MeSH terms:
Birth Weight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on November 20, 2014