Enteral Protein Supplementation in Critically Ill Children: A Randomized Controlled Pilot and Feasibility Study

BACKGROUND: Loss of muscle mass in critically ill children can negatively impact outcomes. The aims of this study were to conduct a pilot randomized control trial (RCT) to examine the difference in protein delivery and nitrogen balance in critically ill children with enteral protein supplementation vs controls. We also aimed to assess the feasibility, safety, and tolerance of the pilot trial. METHODS: This is a 3-arm RCT in critically ill children eligible for enteral nutrition (EN) therapy. Patients were randomized to 1 of the 3 groups: (1) control (routine EN), (2) polymeric protein module added to EN to reach protein goal by day 4, or (3) oligomeric protein supplementation. Demographics, clinical characteristics, nutrition status, and daily nutrition intake variables were recorded. Protein delivery, nitrogen balance, feasibility variables, and rate of adverse events were the outcomes. RESULTS: After screening 286 consecutive patients admitted to the pediatric intensive care unit over 11 months, we enrolled and randomized 25 patients. Twenty-two patients (88% of the enrolled) completed the study procedures. Significantly higher protein prescription and actual protein intake within the first 5 days was achieved in the intervention groups, compared with the control group. Nitrogen balance was obtained in 15 patients. There was no significant difference between the groups for the rate of adverse effects and clinical outcomes. CONCLUSION: In our pilot trial, protein supplementation was safe and well tolerated. Our preliminary results suggest that a larger RCT is potentially feasible, with some modifications of the entry criteria. Trial enrollment was low, likely due to restrictive entry criteria.