Home > A randomised, double-blind, controlled trial of the effect of prebiotic oligosaccharides (OS) on enteral tolerance in preterm infants

A randomised, double-blind, controlled trial of the effect of prebiotic oligosaccharides (OS) on enteral tolerance in preterm infants

Modi N et al. Pediatr Res 2010;68:440-5

 

Summary

Enteral feeding rather than parenteral (intravenous) feeding is preferred in preterm babies. Many factors make establishing and maintaining feeds difficult in preterm babies; colonisation with beneficial bacteria improves feed tolerance, and human milk is a rich source of prebiotic OS. Breastfeeding should be promoted and encouraged in neonatal units, but many mothers struggle to provide sufficient milk.

Aim

To test the hypothesis that a preterm formula containing 0.8g prebiotic OS per 100ml (at a 9:1 ratio of Galacto-oligosaccharides to Fructo-oligosaccharides) improves enteral tolerance in preterm babies.

Study design

A UK multicentre, double-blind, randomised controlled trial comparing a prebiotic OS-containing preterm formula with a non-prebiotic-containing preterm formula on enteral tolerance. Formula was only used when there was insufficient breast milk. Infants were randomised within 24 hours of birth.

The primary outcome was the number of days from birth to establish a total daily enteral intake of 150ml/kg/day. The principal secondary outcome was the proportion of days between birth and 28 days or discharge that a total daily milk intake of at least 150ml/kg/day was tolerated.

Results

• Final data available for 150 babies for the primary outcome and 154 for the principal secondary outcome.

• There were no significant differences between the groups in the primary or secondary outcomes.

•  After covariate adjustment there was improved enteral tolerance:

• 2.9% higher in prebiotic OS group for infants at 28 weeks; 9.9% higher in those born at 26 weeks (Figure 1)

• in a subgroup of infants in prebiotic OS group in hospital >20 days (Figure 2)

Conclusions

A formula with prebiotic OS may improve enteral tolerance in very preterm infants <29 weeks versus a non-prebiotic-containing preterm formula.