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Published on: January 27, 2019
Bifidobacterium and enteral feeding in preterm infants: cluster-randomized trial
Satsuki Totsu1, Chika Yamasaki, Masaki Terahara
1Maternal and Perinatal Center, Tokyo Women's Medical University, Tokyo, Japan.
Insights
Bifidobacterium bifidum supplementation in very low-birthweight infants accelerates enteral feeding establishment. This probiotic intervention also significantly reduced the incidence of late-onset sepsis without adverse effects.
Area of Science:
- Neonatal nutrition and gastroenterology
- Microbiome research in infant health
- Clinical trial methodology in pediatrics
Background:
- Very low-birthweight (VLBW) infants (<1500 g) often face challenges with enteral feeding establishment.
- The role of probiotics, specifically Bifidobacterium bifidum OLB6378, in supporting VLBW infant nutrition is under investigation.
- Early enteral feeding is crucial for VLBW infant growth and development.
Purpose of the Study:
- To evaluate the efficacy of Bifidobacterium bifidum OLB6378 in accelerating enteral feeding in VLBW infants.
- To assess the impact of B. bifidum supplementation on the incidence of morbidity and somatic growth in VLBW infants.
- To determine the safety profile of B. bifidum in this vulnerable infant population.
Main Methods:
- A cluster-randomized, double-blind, placebo-controlled trial involving 19 hospitals.
- VLBW infants received either B. bifidum (B group) or placebo (P group) within 48 hours of birth.
- Primary outcome: establishment of enteral feeding ( >100 mL/kg/day); secondary outcomes: morbidity and growth.
Main Results:
- Enteral feeding was established significantly earlier in the B. bifidum group (11.0 days) compared to the placebo group (12.1 days).
- The incidence of late-onset sepsis was significantly lower in the B. bifidum group (3.9%) versus the placebo group (10.0%).
- No significant differences were observed in somatic growth or other adverse outcomes, including mortality.
Conclusions:
- Bifidobacterium bifidum OLB6378 effectively accelerates the establishment of enteral feeding in VLBW infants.
- Supplementation with B. bifidum is associated with a reduced risk of late-onset sepsis in VLBW infants.
- B. bifidum administration is safe and well-tolerated in VLBW infants, with no increased incidence of adverse effects.
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.
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