Effect of Bifidobacterium Bifidum Supplementation on Morbidity of Very Low Birth Weight Infants
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 246
- Locations
- 1
- Primary Endpoint
- Postnatal day when enteral feeding exceeded at 100ml/kg/day
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- — to 48 Hours (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Active
Bifidobacterium bifidum
Intervention: Bifidobacterium bifidum supplementation (Dietary Supplement)
Placebo
Dextrin without Bifidobacterium bifidum
Intervention: Placebo contains dextrin (Dietary Supplement)
Outcomes
Primary Outcomes
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
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 Outcomes
- 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)
Investigators
Satoshi Kusuda
Professor of Neonatology
Tokyo Women's Medical University