Growth of infants fed formula with evolving nutrition composition: A single‐arm non‐inferiority study

Abstract

The nutritional composition of human milk evolves over the course of lactation, to match the changing needs of infants. This single‐arm, non‐inferiority study evaluated growth against the WHO standards in the first year of life, in infants consecutively fed four age‐based formulas with compositions tailored to infants’ nutritional needs during the 1st, 2nd, 3rd–6th, and 7th–12th months of age. Healthy full‐term formula‐fed infants (n = 32) were enrolled at ≤14 days of age and exclusively fed study formulas from enrollment, to the age of four months. Powdered study formulas were provided in single‐serving capsules that were reconstituted using a dedicated automated preparation system, to ensure precise, hygienic preparation. The primary outcome was the weight‐for‐age z‐score (WAZ) at the age of four months (vs. non‐inferiority margin of −0.5 SD). Mean (95% CI) z‐scores for the WAZ (0.12 (−0.15, 0.39)), as well as for the length‐for‐age (0.05 (−0.19, 0.30)), weight‐for‐length (0.16 (−0.16, 0.48)), BMI‐for‐age (0.11 (−0.20, 0.43)), and head circumference-for‐age (0.41 (0.16, 0.65)) at the age of four months, were non‐inferior. Throughout the study, anthropometric z‐scores tracked closely against the WHO standards (within ±1 SD). In sum, a fourstage, age‐based infant formula system with nutritional compositions tailored to infants’ evolving needs, supports healthy growth consistent with WHO standards, for the first year of life.