Amoxicillin for critically ill children with enteral nutrition intolerance (AmoxENI study): A randomized controlled trial.

Abstract

Objectives: To investigate the efficacy of amoxicillin in treating children with enteral nutrition intolerance (ENI) in the pediatric intensive care unit (PICU).

Methods: This randomized controlled trial enrolled 90 children aged 1 month to 12 years with ENI 7 days after PICU admission. On the 8th day of PICU admission, participants were equally randomized to receive either amoxicillin (10 mg/kg) or a placebo via a gastric feeding tube three times daily for 1 week. The primary outcome was achieving an enteral intake ≥ two-thirds of the energy requirement without remarkable gastrointestinal symptoms on Day 7 after study drug administration. Secondary outcomes were the increase in enteral nutrition intake and the occurrence of large gastric residual volume, vomiting, diarrhea, abdominal distention, melena/hematochezia, and skin rash.

Results: The primary outcome occurred in 75.6% of participants in the amoxicillin group compared to 31.1% in the placebo group (risk ratio [RR]: 2.4; 95% confidence interval [CI]: 1.5-3.9; p < 0.001). Compared with placebo, participants who received amoxicillin demonstrated a higher increase in enteral nutrition intake (median [interquartile range]: 60% [40%-68%] vs. 24% [10%-50%], p < 0.001) as well as a lower occurrence of vomiting (2.2% vs. 35.6%; RR: 0.06, 95% CI: 0.01-0.45) and diarrhea (8.9% vs. 31.1%; RR: 0.29, 95% CI: 0.10-0.80). Both groups showed no significant differences in other outcomes.

Conclusions: Amoxicillin may improve ENI in critically ill children, but further research is warranted to corroborate our findings, explore underlying pharmacological mechanisms, and evaluate clinical utility.

Trial registration: ClinicalTrials.gov identifier: NCT05828758.