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2'-Fucosyllactose Effects on Preterm Growth, Tolerance, and Neurobehavior: A Double-Blind, Randomized,
Ethan A Mezoff1, Qing Duan2, Nicholas J Ollberding2,3
1Division of Pediatric Gastroenterology, Hepatology, and Nutrition, Nationwide Children's Hospital, The Ohio State University College of Medicine, Columbus, OH 43205, USA.
Insights
Supplementing preterm infants with 2'-fucosyllactose (2'-FL), a human milk oligosaccharide (HMO), was found to be safe and well-tolerated. This pilot study indicates 2'-FL supports adequate growth and neurobehavior in this vulnerable population.
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.
Abstract:
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.
