(LB04-06-25) First Year Outcomes of Infants Fed an Infant Formula With 5 Specific Human Milk Oligosaccharides (HMOs): A Large, Randomized, Controlled Trial

Objectives: Breastfeeding is the gold standard nutrition for infants. Few studies on infant nutrition have investigated the entire year of infancy. Of infant formulas with HMOs, only 2 clinical studies have fed beyond 6 months of age. The goal of this RCT was to evaluate growth, development, and parent-reported health in infants through 12 months of age.

Methods: Breastfed infants were enrolled into a non-randomized human milk-fed group (HM) and formula-fed infants were randomized to receive either a formula (SF) with 2.5 g/L of 5 HMOs (2′-FL, 3-FL, LNT, 3′-SL, and 6′-SL) or a control formula (CF) without HMOs through 12 months of age. Generalized linear models or contingency table statistical methods were used (SAS® 9.4). P-values≤0.05 were considered significant.

Results: Results reflect 6-12 months of age measures from this clinical study. By 12 months of age, 354 infants were considered protocol evaluable: 101 fed HM, 130 SF, and 123 CF. Complementary foods were introduced around 6 months of age. Anthropometric z-scores were overall not significantly different, as were the percentage of feedings with spit-up and/or vomit within 1 hour of feeding among groups through 12 months of age (P>0.05). From a Toddler Behavior Questionnaire, parents rated SF-fed infants as more physically active (least squares mean±standard error (LSM±SE): 8.92±0.21 (n=105) vs 8.52±0.22 (n=99), P=0.034) and perceived their infants getting the right nutrition over CF (LSM±SE: 9.63±0.15 (n=105) vs 9.28±0.15 (n=99), P=0.038). The risk of Respiratory Tract Infections without Ear Infections was 17% lower in infants fed SF (n=226) vs. CF (n=222) (relative risk (RR)=0.83, 95% CI: 0.69, 0.99, P=0.040). Among those infants with GI Infections, the mean duration of GI infections was shorter in infants fed SF (n=11) than CF (n=15) (days: 4.48 vs 25.75, P=0.004) through 12 months of age. Infants fed SF were more likely to perform better on 2 cognitive tests than infants fed CF (MacArthur-Bates). Significantly more infants fed CF had adverse events than SF through 12 months of age (Yes: 80.6% (n=179) vs 70.4% (n=159), P=0.012). 

Conclusions: For the first time, normal and age-appropriate growth, GI tolerance, immune support, and cognitive outcomes were demonstrated in infants fed a formula with 5 HMOs through 12 months of age (NCT04957992).

Funding Sources: Abbott Nutrition