Effects and Tolerance of Protein and Energy-Enriched Formula in Infants Following Congenital Heart Surgery: A Randomized Controlled Trial

Background: Nutrition support is important for clinical management to improve outcomes of infants following congenital heart surgery. Protein-enriched and energy-enriched formula (PE-formula) may help provide adequate nutrition and promote wound healing. However, the effects and tolerance of increased protein and energy intakes of these infants have not been well defined. Objective: To evaluate nutrition effects and tolerance of a PE-formula compared with the standard formula (S-formula) in infants in the first 5 days after congenital heart surgery. Methods: Fifty infants were randomly assigned to S-formula (S-group, n = 24) or PE-formula (PE-group, n = 26). Daily nutrient intakes and tolerance were recorded. Plasma amino acid concentrations were measured. Cumulative energy balance and nitrogen balance were calculated. Results: Nutrient intakes were significantly higher in the PE-group after day 1, and all met the adequate intakes as early as day 2. Nitrogen balance in the PE-group met positive balance from day 2, whereas in the S-group, this was not until day 5. The PE-group also had a significantly higher increase in many essential amino acids. With the exception of tolerable diarrhea (multivariate adjusted hazard ratio, 3.16; 95% confidence interval, 1.24-8.01), the PE-group did not have a significantly higher incidence of intolerable events. Conclusions: In infants during the early postoperative period after congenital heart surgery, early administration of PE-formula was as well tolerated as S-formula and effective in achieving higher nutrition intakes and earlier nitrogen balance. Further research is warranted to support the use of PE-formula in this special group of infants.