title: Bifidobacterium and enteral feeding in preterm infants: cluster-randomized trial.
abstract: BACKGROUND
  This study evaluated the benefit of Bifidobacterium bifidum OLB6378 (B. bifidum) in very low-birthweight (VLBW) infants (birthweight <1500 g) for the acceleration of enteral feeding.
  
  
  METHODS
  A cluster-randomized, double-blind, placebo-controlled trial was conducted in 19 hospitals, divided into two groups: the B group (n = 10 hospitals; B. bifidum given to infants within 48 h of birth) and the P group (n = 9 hospitals; infants received a placebo). The primary outcome was establishment of enteral feeding after birth, defined as the postnatal day at which enteral feeding exceeded 100 mL/(kg/day). Secondary outcomes were defined as incidence of morbidity and somatic growth before discharge.
  
  
  RESULTS
  Overall, 283 VLBW infants were enrolled in the study: B group, n = 153; and P group, n = 130. Enteral feeding was established within 21 days after birth in 233 infants, of whom 119 received B. bifidum and 114 received placebo until their bodyweight reached 2000 g. Enteral feeding was established significantly earlier in the B group, at 11.0 ± 3.6 days versus 12.1 ± 3.8 days in P group (P < 0.05). Infant growth during the stay in the neonatal intensive care unit was not different between groups, but the incidence of late-onset sepsis among all enrolled infants was significantly lower in the B group (3.9%, 6/153) than in the P group (10.0%, 13/130; P < 0.05). No differences were observed in the incidence of other adverse outcomes including mortality.
  
  
  CONCLUSIONS
  B. bifidum in VLBW infants accelerated the establishment of enteral feeding after birth without increasing the incidence of adverse effects.
authors.affiliation: Maternal and Perinatal Center, Tokyo Women's Medical University, Tokyo, Japan.
authors.forename: Satsuki
authors.initials: S
authors.lastname: Totsu
authors.forename: Chika
authors.initials: C
authors.lastname: Yamasaki
authors.forename: Masaki
authors.initials: M
authors.lastname: Terahara
authors.forename: Atsushi
authors.initials: A
authors.lastname: Uchiyama
authors.forename: Satoshi
authors.initials: S
authors.lastname: Kusuda
mesh_terms: D001644:Bifidobacterium; D004311:Double-Blind Method; D004750:Enteral Nutrition; D005260:Female; D006801:Humans; D007231:Infant, Newborn; D007234:Infant, Premature; D019102:Infant, Very Low Birth Weight; D008297:Male
keywords: establishment of enteral feeding; necrotizing enterocolitis; neonate; probiotics; sepsis