Early enteral administration of immunonutrition in critically ill children: results of a blinded randomized controlled clinical trial

OBJECTIVES: In a blinded, prospective, randomized, controlled clinical trial, we compared nitrogen balance (NB), nutritional indices, antioxidant catalysts, and outcome in critically ill children given an immune-enhancing formula (I) or conventional early enteral nutrition (C). METHODS: Fifty patients, 103 +/- 7 months old, with disorders prompting admission to the pediatric intensive care unit, including sepsis, respiratory failure, and severe head injury, were enrolled in the study. Within 12 h of admission, patients were randomized to receive I (n=25) or C (n=25). Caloric intake was aimed at meeting patient's predicted basal metabolic rate by day 2 and predicted energy expenditure by day 4, irrespective of group assignment. Outcome endpoints and complications were recorded; NB, transthyretin, retinol-binding protein, transferrin, zinc, copper, and metabolic indices were measured on days 1 and 5 and compared with clinical and nutritional characteristics within and between groups. RESULTS: Both diets achieved their initial targets of covering predicted basal metabolic rate by day 2 and predicted energy expenditure by day 4. Twenty four-hour NB became positive in 40% of patients in group C and occurred in 64% of patients in group I by day 5. Only in group I did the mean NB become positive by day 5 (0.07+/-0.07 g/kg versus -0.24+/-0.03 g/kg on day 1, P<0.001) compared with group C in which the mean NB remained negative (-0.06+/-0.04 g/kg versus -0.25+/-0.06 g/kg on day 1, P<0.001). By day 5, nutritional indices and antioxidant catalysts showed a higher increasing trend in group I compared with group C and higher osmolality (P<0.02), sodium (P<0.03), and urea (P<0.04). Diarrhea for group I (P<0.02) and gastric distention for group C (P<0.04) were the most frequently recorded complications. Mortality or length of stay did not differ between groups, but there was a trend for less gastric gram plus isolates (P<0.05) or for Candida species (P<0.04) and nosocomial infections in group I compared with group C. CONCLUSIONS: Although less well tolerated, immunonutrition is a feasible method of early enteral nutrition in the pediatric intensive care unit. It has a favorable effect on nutritional indices and antioxidant catalysts, but not on outcome hard endpoints. Although it poses a higher metabolic burden to the patient, it shows a trend to improve colonization and infection rates. Appropriate modifications for specific age populations might improve its tolerability and benefits among critically ill children.