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Amoxicillin for critically ill children with enteral nutrition intolerance (AmoxENI study): A randomized controlled
Rania G Abdelatif1, Abanob A Francis1, Elsayed Abdelkreem1
1Department of Pediatrics, Faculty of Medicine, Sohag University, Sohag, Egypt.
Insights
Amoxicillin significantly improved enteral nutrition intolerance in critically ill children. This treatment led to better nutritional intake and fewer gastrointestinal symptoms, suggesting a potential therapeutic role.
Area of Science:
- Pediatric critical care medicine
- Clinical pharmacology
- Gastroenterology
Background:
- Enteral nutrition intolerance (ENI) is a common challenge in pediatric intensive care units (PICUs).
- Effective management of ENI is crucial for improving patient outcomes.
- ClinicalTrials.gov identifier: NCT05828758.
Purpose of the Study:
- To evaluate the efficacy of amoxicillin in treating ENI in children admitted to the PICU.
- To assess the impact of amoxicillin on nutritional intake and gastrointestinal symptoms.
Main Methods:
- A randomized controlled trial involving 90 children (1 month to 12 years) with ENI.
- Participants received either amoxicillin (10 mg/kg) or placebo via gastric tube three times daily for one week.
- Primary outcome: achieving ≥2/3 energy requirement without significant GI symptoms on Day 7 post-treatment.
Main Results:
- Amoxicillin group achieved the primary outcome in 75.6% vs. 31.1% in placebo (RR: 2.4, p<0.001).
- Amoxicillin significantly increased enteral nutrition intake (60% vs. 24%, p<0.001) and reduced vomiting and diarrhea.
- No significant differences were observed in other secondary outcomes between groups.
Conclusions:
- Amoxicillin shows promise in improving ENI in critically ill children.
- Further research is needed to confirm findings, explore mechanisms, and assess clinical utility.
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.
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