Growth and Nutritional Biomarkers of Preterm Infants Fed a New Powdered Human Milk Fortifier

Abstract

Objectives:The aim of this study was to assess growth and nutritional biomarkers of preterm infants fed human milk (HM) supplemented with a new powdered HM fortifier (nHMF) or a control HM fortifier (cHMF). The nHMF provides similar energy content, 16% more protein (partially hydrolyzed whey), and higher micronutrient levels than the cHMF, along with medium-chain triglycerides and docosahexaenoic acid.Methods:In this controlled, multicenter, double-blind study, a sample of preterm infants ≤32 weeks or ≤1500 g were randomized to receive nHMF (n = 77) or cHMF (n = 76) for a minimum of 21 days. Weight gain was evaluated for noninferiority (margin = –1 g/day) and superiority (margin = 0 g/day). Nutritional status and gut inflammation were assessed by blood, urine, and fecal biochemistries. Adverse events were monitored.Results:Adjusted mean weight gain (analysis of covariance) was 2.3 g/day greater in nHMF versus cHMF; the lower limit of the 95% CI (0.4 g/day) exceeded both noninferiority (P < 0.001) and superiority margins (P = 0.01). Weight gain rate (unadjusted) was 18.3 (nHMF) and 16.8 g · kg−1 · day−1 (cHMF) between study days 1 and 21 (D1–D21). Length and head circumference (HC) gains between D1 and D21 were not different. Adjusted weight-for-age z score at D21 and HC-for-age z score at week 40 corrected age were greater in nHMF versus cHMF (P = 0.013, P = 0.003 respectively). nHMF had higher serum blood urea nitrogen, pre-albumin, alkaline phosphatase, and calcium (all within normal ranges; all P ≤ 0.019) at D21 versus cHMF. Both HMFs were well tolerated with similar incidence of gastrointestinal adverse events.Conclusions:nHMF providing more protein and fat compared to a control fortifier is safe, well-tolerated, and improves the weight gain of preterm infants.

Comparative study of preterm infants fed new and existing human milk fortifiers showed favourable markers of gastrointestinal status

“…The study flow diagram, baseline subject characteristics and parental demographics have previously been reported . A total of 153 infants were enrolled and randomised to either the new fortifier (n = 77) or the control fortifier (n = 76).…”

“…However, it is unlikely that the alpha‐1 antitrypsin content of human milk contributed to the small, but significant, difference between the groups on study day 21, since each group consumed a very similar volume of fortified milk during the study period. This was 153 mL/kg/d in both groups, with 49% of the volume from donor milk in the new fortifier group and 51% in the control fortifier group . Alternatively, it can be speculated that these results indicate a slight, but significant, increase in gastrointestinal protein loss and, or, inflammation among infants in the control than new fortifier groups.…”

“…We included clinically stable preterm infants born from April 2011 to March 2014 at up to 32 weeks of gestation or with a birthweight of up to 1500 g. The mothers agreed to provide expressed or donor breast milk for the 21‐day study duration. The inclusion and exclusion criteria have previously been reported …”

“…Faecal biomarkers were the secondary endpoints of a trial that evaluated weight gain velocity, other growth parameters and nutritional biomarkers, including lipid profiles, in clinically stable preterm infants The new fortifier was PreNAN Human Milk Fortifier (Nestlé, Vevey, Switzerland), and the control fortifier was FM85 Human Milk Fortifier (Nestlé, Vevey, Switzerland). The primary results of the trial have already been reported . Briefly, they showed that the unadjusted weight gain rate was 18.3 g/kg/d for the new fortifier and 16.8 g/kg/d for the control fortifier and that both fortifiers were well tolerated, with a similar incidence of adverse gastrointestinal events.…”

Milk Curd Obstruction in Human Milk-Fed Preterm Infants

“…To achieve extrauterine growth similar to intrauterine trajectories, very preterm infants require more protein than the amounts provided by breast milk [27]. Results of several randomised controlled trials suggest that the gap cannot be overcome by increasing the amounts of amino acids provided by parenteral nutrition [28-30], whereas adding protein to human milk promotes the growth of extremely preterm infants [31-34]. However, there is an apparent ceiling at around 4 g/kg/day [35].…”