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

Objectives: Preterm infants confront multiple coexistent health risks and may not receive human milk (HM), which contains human milk oligosaccharides (HMOs), among other biologically active, beneficial components. 2'-Fucosyllactose (2'-FL) is the most abundant HMO in most HM. Interventional studies of formula with added HMOs have demonstrated multiple beneficial outcomes in healthy, term infants. Methods: This double-blind, randomized, placebo-controlled pilot study (NCT03306316) evaluated the effect of a 2'-FL supplement on growth, tolerance, and neurobehavior, as assessed by the Neonatal Intensive Care Unit (NICU) Network Neurobehavioral Scale (NNNS), in preterm infants. Eligible neonates born between 26 0/7 and 31 6/7 weeks gestational age (GA) were enrolled from three NICUs in the United States. Preterm infants consuming mother's own milk or donor human milk were randomized to receive a supplement of 0.135 g/mL of 2'-FL or 0.05 g/mL dextrose (placebo) twice daily until 36 weeks corrected GA, NNNS assessment, or hospital discharge, whichever came first. Results: Of 42 participating preterm infants, 23 (55%) received 2'-FL and demonstrated no significant differences in growth in weight, length, or head circumference over 5 weeks. There were also no differences in stool frequency, adverse (AEs) or serious adverse events (SAEs), or neurobehavior (NNNS) between groups. Conclusions: This pilot study found that 2'-FL supplementation in preterm infants through 36 weeks corrected GA was safe and well-tolerated and supported adequate growth and neurobehavior.