A double-blind randomized, controlled trial of protein energy–enriched formula administered to critically ill infants

INTRODUCTION: Nutritional support is an important aspect of clinical management of critically ill infants, but the nutritional requirements of these infants are not well defined. OBJECTIVE: Our goal was to compare tolerance, nutritional, and metabolic effects of 2 different infant formulas in critically ill infants in a double-blind, randomized way. METHODS: Eighteen ventilated infants with respiratory insufficiency caused by respiratory syncytial virus infection were included and received an energy- and protein-enriched (PE) infant formula (Infatrini [Nutricia B. V. Zoetermeer, Zoetermeer, Netherlands]; n = 8) or standard infant formula (Nutrilon 1 [Nutricia B. V. Zoetermeer]; n = 10). Daily intake and tolerance (gastric retention, diarrhea) were recorded. Resting energy expenditure, respiratory quotient, L-amino acid concentrations, and metabolic parameters were measured, and cumulative energy balance, nitrogen balance, and substrate utilization were calculated. RESULTS: Baseline characteristics were similar in both groups. Both formulas were well tolerated with similar volumes of intake. Results from day 4 are presented in Table 1. Levels of several amino acids (His, Val, Met, Phe, Lys, and ornithine; P < .05) were significantly higher in the infants who received the PE-enriched formula. CONCLUSIONS: PE-enriched infant formula was well tolerated in critically ill infants and effective in achieving higher nutritional intakes in the first days of admission. PE-enriched formula improved energy balance and plasma amino acid profile, and a trend toward increased nitrogen balance was found. TABLE 1.Results on Day 4 of AdmissionFormulaProtein Intake, g/kg per dayEnergy Intake, kcal/kg per dayaResting Energy Expenditure, kcal/kg per dayaRespiratory QuotientCumulative Energy Balance, kcal/kg per dayaCumulative Nitrogen Balance, mg/kg per dayPE-enriched (n = 8)2.61 ± 0.24111 ± 1059 ± 50.98 ± 0.02589 ± 115162 ± 32Standard (n = 10)1.46 ± 0.1178 ± 449 ± 40.91 ± 0.01350 ± 5068 ± 16 P <.01<.01.26<.01<.05.08a1 kcal = 4.2 kJ.