Early enteral administration of immunonutrition in critically ill children: results of a blinded randomized controlled clinical trial.
OBJECTIVE
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.
Pediatric Intensive Care Unit, University Hospital of Heraklion, Crete, Greece; Pediatric Intensive Care Medicine, Aghia Sophia Children's Hospital, Athens, Greece. ggbriass@med.uoc.gr
George
G
Briassoulis
Olga
O
Filippou
Eugenia
E
Hatzi
Ioannis
I
Papassotiriou
Tassos
T
Hatzis
D000975:Antioxidants / Q000378:metabolism; D002648:Child; D016638:Critical Illness / Q000401:mortality / Q000628:therapy*; D004311:Double-Blind Method; D004734:Energy Metabolism; D004750:Enteral Nutrition / Q000009:adverse effects / Q000379:methods* / Q000592:standards; D005260:Female; D005526:Food, Formulated / Q000145:classification*; D006801:Humans; D007121:Immunocompetence; D007239:Infections / Q000453:epidemiology; D015278:Intensive Care Units, Pediatric; D007902:Length of Stay; D008297:Male; D009584:Nitrogen / Q000378:metabolism*; D009752:Nutritional Status; D011446:Prospective Studies; D016896:Treatment Outcome
D000975:Antioxidants; D009584:Nitrogen