Several lines of evidence suggest that formula with protein content of 3.0 g/100 kcal does not fully meet the protein needs of very-low-birth weight infants. Our purpose was to compare nitrogen balance, metabolic status and growth in infants fed a standard (3.0 g/100 kcal; RegPro) and high (3.6 g/100 kcal; HiPro) protein infant formula. Infants were fed both formulas, each formula for one week in balanced cross-over design. Metabolic status was monitored throughout. Nutrient balance and plasma amino acids were determined at the end of each week. Data were analysed using a linear mixed model. Eighteen infants were studied. Nine infants received the RegPro and nine received HiPro formula first. Nitrogen intake, absorption and retention were greater with the HiPro formula. None of the infants developed uremia or metabolic acidosis but retinol-binding-protein and weight gain were greater with the HiPro formula. Increased protein accretion paralleled by better weight gain without evidence of metabolic stress indicates that a formula with a protein content of 3.6 g/100 kcal better meets protein needs in these rapidly-growing infants. Further studies are needed to determine whether these short-term outcomes will be translated into long-term benefits. T here is compelling evidence that premature infants frequently do not receive protein intakes that meet their needs (1,2). In the case of formula-fed infants, one critical reason is that pre-term formulas contain too little protein. The protein needs of premature infants are reasonably well established based on the factorial method and experimental data. By one estimate, protein requirements are 4.0 g/kg/d for infants weighing less than 1200 g, decreasing to 3.9 g/kg/d for infants weighing 1200 -1500 g (3). Expressed per unit of energy, the requirements for protein are 3.8 g/100 kcal for infants weighing 500 -700 g, decreasing gradually to 3.1 g/100 kcal for infants weighing 1200 -1500 g (3).A formula that provides 3.0 g/100 kcal, therefore, cannot provide an adequate intake of protein. If needs of these infants are to be met, a formula must provide more than 3.0 g/100 kcal. We, therefore, hypothesized that a formula with a protein concentration of 3.6 g/100 kcal would lead to greater nitrogen retention and greater short term weight gain than a formula with a protein concentration of 3.0 g/100 kcal. The present study was designed to test this hypothesis.
METHODS AND PROCEDURESStudy design. The study design was based on a previous study in pre-term infants and is outlined in Table 1 (4). It comprised of 2 one-week comparison periods during which each formula was fed. It was conducted in a double blind fashion, with the sequence of formula feeding randomly determined and balanced. Immediately before the first study formula was fed, baseline (anthropometric, metabolic) determinations were made. After a minimum equilibration period of 72 h, anthropometric and metabolic determinations were repeated and the first metabolic balance study was begun. At the end of the fi...