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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
246
Bifidobacterium bifidum supplementation wiht approximately 2.5\*10to9th bacteria per day
0.5 of dextrin
Tokyo Women's Medical Unversity
Shinjuku, Tokyo, Japan
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.
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
standard deviation(SD) scores of bodyweight(BW) and head circumference(HC)
BW gain/day, SD scores of BW and HC at discharge from NICU
Time frame: For the duration of NICU stay, an expected average of 3 months
Necrotizing enterocolitis or sepsis
The incidences of necrtizing enterocolitis or sepsis during the stay in NICU
Time frame: For the duration of NICU stay, an expected average of 3 months
Intestinal flora
Intestinal flora during the stay in NICU
Time frame: For the duration of NICU stay, an expected average of 3 months
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