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

Authors

1 Associate Professor of Isfahan Faculty of Medicine, Division of Neonatology, Department of Pediatrics, Child Growth and Development Research Center, Research Institute for Primordial Prevention of Non-communicable Disease, Isfahan University of Medical Science, Isfahan, Iran.

2 MD, General Physician, Department of Health, Academic Member of Almahdi-Mehr Isfahan Higher Education Institution, Isfahan, Iran.

3 MD, Associate Professor of Isfahan Faculty of Medicine, Department of Pediatrics, Child Growth and Development Research Center, Research Institute for Primordial Prevention of Non-communicable Disease, Isfahan University of Medical Science, Isfahan, Iran.

4 MD, Resident of Pediatrics, Medical Faculty, Isfahan University of Medical Sciences, Isfahan, Iran.

5 MD, Kashan University of Medical Sciences, Kashan, Iran.

Abstract

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.
Materials 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.
Results
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.
Conclusion
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.

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