Growth of infants consuming whey-predominant term infant formulas with a protein content of 1.8 g/100 kcal: a multicenter pooled analysis of individual participant data

Abstract

Whey-predominant infant formula with a lower protein content that more closely resembles that of breast milk supports healthy growth comparable to the WHO growth standards and close to breastfed infants.

Growth of Infants Fed Formula with Evolving Nutrition Composition: A Single‐Arm Non‐Inferiority Study

“…BMIAZ did not differ from 0 at any time point, except at 12 months, when it was significantly >0. HCAZ was significantly >0 at all time points; this particular finding is consistent with recent observations [18,22], which showed that WHO head circumference data are consistently lower than measurements from large studies of economically advantaged children. Collectively, these findings suggest that further considerations are needed in regard to using a single international head circumference standard.…”

“…For growth from birth to 12 months of age, the mean change (SD) in WAZ was 0.49 (1.2); the proportion of infants in “slow”, “gradual”, and “rapid” categories was 22%, 30%, and 48%, respectively. In a recent large-scale pooled analysis of 11 randomized controlled trials [18], the proportion of infants with a WAZ change from birth to four months of age in “slow”, “gradual”, and “rapid” categories, was 27%, 52%, and 21% among infants fed lower protein formulas without active ingredients (1.8 g protein/100 kcal); was 22%, 52%, and 26% among infants fed lower protein formulas with active ingredients (1.8 g protein/100 kcal with prebiotics, probiotics, or both); and was 42%, 49%, and 9% among breastfed infants (Figure 3), respectively.…”

“…To our knowledge, the innovative nutrition system used in this study represents the first attempt to match multiple aspects of the dynamic nutrition pattern provided in human milk over the course of the first year of life. This study demonstrated that the staged formula system, including an automated formula preparation system and four formulas with an evolving nutrition profile similar to changes in human milk from birth to 12 months of age, (i) is safe and well-tolerated; (ii) supports age-appropriate healthy growth (compared to the WHO growth standards); and (iii) supports an early weight gain pattern from birth to the age of four months, close to infants fed formulas with 1.8 g protein/100 kcal [18], the lowest regulatory-permissible protein level in infant formula in the United States and Europe [23,24,25]. …”

“…We explored the weight gain pattern from birth to four months of age (when infants were still exclusively fed study formulas) in the study. It appeared that infants in the study tended to grow at a slightly faster rate compared to infants exclusively fed formulas of 1.8 g protein/100 kcal with/without other active ingredients, from soon after birth to four months of age, in a recent large-scale pooled analysis [18]. Specifically, a higher proportion of infants in the present study was in the “gradual” weight gain category and a lower proportion of infants was in the “slow” weight gain category.…”

“…The change in WAZ was classified as “slow” (<−0.67 SD), “gradual” (−0.67 SD to 0.67 SD), or “rapid” (>0.67 SD), as previously described [18], which are considered equivalent to “downward”, “average”, and “upward” crossings of major weight percentiles in a growth chart (i.e., WHO 2006 Child Growth Standards).…”