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.
Malnutrition is a common problem in critically ill children admitted to the pediatric intensive care unit (PICU) with a reported prevalence up to 57%. This condition is associated with increased length of hospital stay, morbidity (e.g., hospital-acquired infections, weakness, and longer duration of mechanical ventilation), and mortality. Data from observational studies indicate that adequate energy intake is associated with better outcomes in the PICU. Enteral nutrition (EN) is the preferred route to administer nutritional support for critically ill children unless contraindicated. However, EN of critically ill children is challenging, and nutritional targets are commonly not attained. EN intolerance (a clinical manifestation of delayed gastric emptying) is one of the main factors for limited delivery of enteral feeding. Promotility agents are commonly used as a first-line treatment for patients with EN intolerance. In critically ill adults, prokinetics have been shown to improve gastric emptying and enhance tolerance to gastric feeding. Available options include metoclopramide, domperidone, and erythromycin. However, there is insufficient evidence for recommending the use of prokinetics in children with critical illness to enhance gastric emptying and EN tolerance. Furthermore, currently available prokinetics are associated with serious side effects. Amoxicillin/clavulanate combination is one of the most commonly prescribed antibiotics for children worldwide. Besides its antibacterial properties, some studies showed that amoxicillin/clavulanate could have prokinetic effects. However, well-designed randomized controlled trials to confirm the prokinetic effects of amoxicillin/clavulanate are lacking. Additionally, no human study has investigated the prokinetic effects of amoxicillin and clavulanate individually. In a study on juvenile rats, amoxicillin alone, but not clavulanate, was shown to increase the amplitude of spontaneous duodenal contractions. The use of amoxicillin alone rather than amoxicillin/clavulanate could have the advantages of avoiding the side effects of clavulanate, lowering the cost, and decreasing the risk of antibiotic resistance. The goal of this randomized controlled study is to investigate the efficacy of enteral amoxicillin for the treatment of children with EN intolerance in PICU.
Amoxicillin 10 mg/kg (50 mg/ml concentration) by nasogastric tube 3 times daily (8 hours apart) 10 minutes before bolus gastric feeding for 7 days.
Distilled water 0.2 ml/kg by nasogastric tube 3 times daily (8 hours apart) 10 minutes before bolus gastric feeding for 7 days.
Pediatric Intensive Care Unit - Sohag University Hospital
Sohag, Egypt
RECRUITINGFeeding tolerance on day 7
Proportion of participants achieving feeding tolerance (enteral intake ≥ two-thirds of the prescribed daily target in the absence of gastrointestinal symptoms, including large gastric residual volume (≥ 50% of enteral feeding in the last 4 hours), vomiting (≥ 2 times gastric content in 24 hours period), diarrhea (≥ 4 times loose stool with negative fluid balance in 24 hours period), abdominal distention (≥ 2 cm increase in abdominal girth), abdominal pain, melena, or hematochezia) on day 7 study timepoint
Time frame: 7 days
Enteral intake ≥ two-thirds of the prescribed daily target on day 7
Proportion of participants achieving enteral intake ≥ two-thirds of the prescribed daily target on day 7 study timepoint
Time frame: 7 days
Change in achieved percentage of prescribed enteral feeding on day 7 study compared with baseline
Change in achieved percentage of prescribed enteral feeding on day 7 study timepoint compared with baseline
Time frame: 7 days
Large gastric residual volume on day 7
Proportion of participants with large gastric residual volume (≥ 50% of enteral feeding in the last 4 hours) on day 7 study timepoint
Time frame: 7 days
Vomiting on day 7
Proportion of participants with vomiting (≥ 2 times gastric content in 24 hours period) on day 7 study timepoint
Time frame: 7 days
Diarrhea
Proportion of participants with diarrhea (≥ 4 times loose stool with negative fluid balance in 24 hours period)
Time frame: 7 days
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Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
90
Abdominal distention
Proportion of participants with abdominal distention (≥ 2 cm increase in abdominal girth)
Time frame: 7 days
Melena/hematochezia
Proportion of participants with melena/hematochezia
Time frame: 7 days
Skin rash
Proportion of participants with skin rash
Time frame: 7 days