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

Abstract

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.

Bolus gastric feeds improve nutrition delivery to mechanically ventilated pediatric medical patients: Results of the COntinuous vs BOlus multicenter trial

“…There is preliminary evidence to suggest that increased delivery of target protein may reduce the risk of mortality. 2,[31][32][33] Based on our results, we identified a moderate effect size of 0.4 based on protein delivery from initial to first goal study feed. Differences in protein delivery may be a better effect size on which to design future studies.…”

Effectiveness of high versus lower enteral protein intake, considering energy intake, on clinical outcomes in critically ill children: a systematic review protocol

“…(2012),13 which showed that 57 kcal/kg per day and 1.5 g/kg/day of protein were required to achieve positive protein balance, no effectiveness review has been conducted examining the impact of protein intake, and reporting energy intake, on clinical outcomes in critically ill children. Several randomized controlled trials, including recent ones, have assessed the impact of protein intake higher than 1.5 g/kg per day in critically ill children, and reporting energy intake 19–25. Conducting this review will improve our understanding of the impact of high vs lower protein intake on clinical outcomes, considering energy intake, in critically ill children.…”

“…Several randomized controlled trials, including recent ones, have assessed the impact of protein intake higher than 1.5 g/kg per day in critically ill children, and reporting energy intake. [19][20][21][22][23][24][25] Conducting this review will improve our understanding of the impact of high vs lower protein intake on clinical outcomes, considering energy intake, in critically ill children. It may also clarify this impact on different age groups, including newborns, infants, children, and adolescents, where possible.…”