Discretion of Late Onset Sepsis with Enteral Low Dose Lactulose in Very Premature Infants: A Double-Blind Randomized, Placebo-Controlled Pilot Study

Background:

Neonatal sepsis contributes substantially to neonatal morbidity and mortality, and is an ongoing major global public health challenge. We aimed to evaluate the effects of enteral feeding supplementation of low dose lactulose on the incidence of late onset sepsis in very premature infants.

and Methods In this randomized placebo-controlled trial preterm neonates with very low birth weight (VLBW) randomly received enteral supplementation of 1% lactulose (1 g per 100 mL feeds) (n=27) or distilled water (placebo, n=25) simultaneous with increasing volumes of milk. Incidence of late onset sepsis was considered as primary outcome. Feeding intolerance, time to reach full enteral feeding and duration of hospitalization in the course of the study were considered as secondary outcomes.

Differences in baseline characteristics were not statistically important. The incidence of late onset sepsis was significantly lower in lactulose group compared to placebo (14.8% vs. 40%, p=0.04). The mean time to reach full enteral feeding was 12.85±3.33 and 15.20±5.24 in the lactulose vs. placebo group (p=0.03). Duration of hospitalization, occurrence of necrotizing enterocolitis and body weight on the 30th day of life were not significantly different between the two groups.

Enteral feeding supplementation with low dose lactulose in very premature infants for prebiotic purposes was deemed to be safe and reduced the incidence of late onset sepsis in our study.