Open-label randomised controlled pilot study investigating human milk oligosaccharides supplementation effects in preterm neonates

Rationale for the study At Monash Children’s Hospital (MCH) we routinely administer probiotics (Infloran®, B bifidum + L acidophilus) to preterm neonates born <32 weeks’ gestation or <1800 g birth weight for prevention of sepsis, NEC, death and to reduce the time to reach full feeds. We propose that human milk oligosaccharides (HMOs) might be beneficial in reducing the incidence of sepsis, NEC, death and time to reach full feeds by acting in symbiosis with the probiotics. Study population This prospective open-label randomised controlled pilot study will include preterm neonates of <32 weeks’ gestation, or <1800 g, candidates to receive Infloran®; the neonates will be randomly assigned to two groups: - A probiotics - B probiotics + HMO The following aspects will be investigated: Clinical outcomes and incidence of adverse events. These will be recorded during the 28 days using a standardised collection form already used in previous studies in Australia and NZ.