2'-Fucosyllactose Effects on Preterm Growth, Tolerance, and Neurobehavior: A Double-Blind, Randomized,...

Area of Science:

• Neonatology
• Nutritional Science
• Pediatric Research

Background:

• Preterm infants face significant health risks and may lack human milk (HM) benefits, including human milk oligosaccharides (HMOs).
• 2 -Fucosyllactose (2 -FL) is the most prevalent HMO, and its supplementation in term infant formula shows positive outcomes.
• Previous studies suggest HMOs offer benefits, but their impact on preterm infants requires further investigation.

Purpose of the Study:

• To evaluate the safety and efficacy of 2 -FL supplementation in preterm infants.
• To assess the effects of 2 -FL on growth, tolerance, and neurobehavioral development.
• To determine if 2 -FL supplementation is well-tolerated in preterm neonates.

Main Methods:

• A double-blind, randomized, placebo-controlled pilot study involving preterm infants (26 0/7 to 31 6/7 weeks gestational age).
• Infants received either a 2 -FL supplement or a dextrose placebo twice daily until 36 weeks corrected gestational age.
• Neurobehavior was assessed using the Neonatal Intensive Care Unit (NICU) Network Neurobehavioral Scale (NNNS).

Main Results:

• No significant differences in growth (weight, length, head circumference) were observed between the 2 -FL and placebo groups over 5 weeks.
• Stool frequency, adverse events (AEs), and serious adverse events (SAEs) did not differ between groups.
• Neurobehavioral outcomes, as measured by NNNS, showed no significant differences between supplemented and placebo groups.

Conclusions:

• 2 -FL supplementation is safe and well-tolerated in preterm infants up to 36 weeks corrected gestational age.
• The supplement supported adequate growth and neurobehavioral development in the study population.
• This pilot study provides a foundation for larger trials on HMO supplementation in preterm infants.