Bifidobacterium and enteral feeding in preterm infants: Cluster-randomized trial

BackgroundThis study evaluated the benefit of Bifidobacterium bifidumOLB6378 (B.bifidum) in very low-birthweight (VLBW) infants (birthweight <1500g) for the acceleration of enteral feeding. MethodsA 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 48h 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 100mL/(kg/day). Secondary outcomes were defined as incidence of morbidity and somatic growth before discharge. ResultsOverall, 283 VLBW infants were enrolled in the study: B group, n = 153; and P group, n = 130. Enteral feeding was established within 21days after birth in 233 infants, of whom 119 received B.bifidum and 114 received placebo until their bodyweight reached 2000g. Enteral feeding was established significantly earlier in the B group, at 11.03.6days versus 12.1 +/- 3.8days 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. ConclusionsB.bifidum in VLBW infants accelerated the establishment of enteral feeding after birth without increasing the incidence of adverse effects.