(383) Triple-Arm RCT Comparing Effect of 3 Feeding Regimens on Mortality in Septic Children in the PICU

Introduction: Sepsis and metabolic stress affect critically ill children's energy needs, increasing the risk of overfeeding and underfeeding. Contradictory evidence exists regarding the association between optimal enteral nutrition (EN) with adequate calories and protein and its effect on survival. In critically ill children with sepsis, we aimed to compare the impact of three distinct feeding regimens on mortality.

Methods: This is a single-centre, open-label, RCT (CTRI/2022/03/040754) involving critically ill children aged 1 to 12 years old with sepsis admitted to a tertiary care PICU from July 21 to December 22. Children were randomly assigned to three intervention arms: normocaloric normoproteic (Group1), hypocaloric hyperproteic (Group2), and hypercaloric normoproteic (Group3). Children with gastrointestinal disease, on renal replacement therapy, chronic renal failure, acute liver failure, inborn error of metabolism and diabetic ketoacidosis were excluded. The primary outcome was 28-day mortality, and secondary outcomes were PICU and hospital stay, vasopressor-free days (VFD), dysglycemia, transaminitis, acute kidney injury (AKI), and healthcare-associated infection (HCAI). The data was analysed using SPSS version 26.0. Baseline features were compared using descriptive statistics and qualitative variables was analysed using the chi-square test. P-value < 0.05 was considered significant.

Results: 270 children were enrolled in the study, consisting of 90 in Group-1, 86 in Group-2 and 94 in Group-3. There were 158 males. The mean age 5.8 ± 3.2 years. The 28-day mortality in Group-1 was 11.1%, 15.1% in Group-2, and 14.9% in Group-3 (P=0.68). In Groups 1, 2, and 3, the median PICU stay was 6.5 (4.10), 6 (4.11), and 6 (4.13) days, respectively. There were no significant differences between the three groups in dysglycemia, VFD, incidence of transaminitis, AKI, and HCAI.

Conclusions: Different feeding regimens did not affect the 28-day mortality in critically ill children with sepsis. Further, multicenter studies are required to assess the impact of calories and protein content in EN on mortality and morbidity in critically ill children.