Amoxicillin for Enteral Nutrition Intolerance in Pediatric Intensive Care Unit

• Status: Not yet recruiting
• Trial end date: 2024-05-10
• Target enrollment: 0
• Participant gender: All

Summary

The goal of this randomized controlled study is to investigate the efficacy of enteral amoxicillin for the treatment of children with feeding intolerance in pediatric intensive care unit.

Children with feeding intolerance will be randomized into study and comparison groups. The study group will receive amoxicillin 10 mg/kg by nasogastric tube 3 times daily 10 minutes before bolus gastric feeding for 7 days. The comparison group will receive equal volume of distilled water as a placebo.

The primary outcome will be the improvement of feeding intolerance on day 7 study timepoint.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sohag University
• Treatments: Amoxicillin

Criteria

Inclusion Criteria:

• Age ranges from 1 month to 12 years.

• Nasogastric tube feeding

• Enteral nutrition intolerance after 7 days of admission to the PICU.

Exclusion Criteria:

• Failure to obtain informed consent.

• Allergy or contraindication to amoxicillin or other beta-lactam antibiotics.

• Current or recent (within 7 days) treatment with amoxicillin.

• Ongoing ketogenic diet.

• Clinical contraindications to advance EN feeds (e.g., bowel obstruction/tight stenosis, severe diarrhea/malabsorption, gut ischemia, severe hypoxemia/acidosis, intractable upper gastrointestinal bleeding, abdominal compartment syndrome, high-output fistula).