Lactulose Supplementation in Premature Infants

The Effects of Lactulose Supplementation to Enteral Feedings in Premature Infants - A Pilot Study

A pilot study to test the safety of use of lactulose in preterm infants and to preliminary assess the hypothesis that lactulose would support the early growth of Lactobacilli in the stools of premature infants and possibly would also improve nutritional status and decrease NEC and late-onset sepsis.

Prospective, double-blind, placebo-controlled single center pilot study in 23-34 weeks gestation premature infants. Study group will receive 1% lactulose, while control group will receive 1% dextrose placebo in all their feeds (human milk or preterm formula). Clinical parameters will be followed. Stool samples will be sent for culture.

Inclusion Criteria:

Premature infants were recruited based on the following criteria:

• 23-34 weeks' gestation (as determined by a combination of maternal dates, early prenatal ultrasonography and postnatal gestational age estimation based on physical and neuromuscular signs (New Ballard Score), as long as there will be gestational age agreement between the 3 methods < 2 weeks);
• Absence of major congenital malformations; and
• Informed consent obtained from parents.

Exclusion Criteria:

• Major congenital malformations and parental refusal.