Amoxicillin for Enteral Nutrition Intolerance in Pediatric Intensive Care Unit (AmoxENI)

April 24, 2023 updated by: Abanob Amgad Francis, Sohag University

Efficacy of Amoxicillin for Treatment of Enteral Nutrition Intolerance in Pediatric Intensive Care Unit

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
      • Sohag, Egypt, 82524
        • Recruiting
        • Pediatric Intensive Care Unit - Sohag University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study group
Children receiving amoxicillin
Drug: Amoxicillin
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.
Placebo Comparator: Comparison group
Children receiving placebo
Other: Placebo
Distilled water 0.2 ml/kg by nasogastric tube 3 times daily (8 hours apart) 10 minutes before bolus gastric feeding for 7 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feeding tolerance on day 7
Time Frame: 7 days
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
7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Enteral intake ≥ two-thirds of the prescribed daily target on day 7
Time Frame: 7 days
Proportion of participants achieving enteral intake ≥ two-thirds of the prescribed daily target on day 7 study timepoint
7 days
Change in achieved percentage of prescribed enteral feeding on day 7 study compared with baseline
Time Frame: 7 days
Change in achieved percentage of prescribed enteral feeding on day 7 study timepoint compared with baseline
7 days
Large gastric residual volume on day 7
Time Frame: 7 days
Proportion of participants with large gastric residual volume (≥ 50% of enteral feeding in the last 4 hours) on day 7 study timepoint
7 days
Vomiting on day 7
Time Frame: 7 days
Proportion of participants with vomiting (≥ 2 times gastric content in 24 hours period) on day 7 study timepoint
7 days
Diarrhea
Time Frame: 7 days
Proportion of participants with diarrhea (≥ 4 times loose stool with negative fluid balance in 24 hours period)
7 days
Abdominal distention
Time Frame: 7 days
Proportion of participants with abdominal distention (≥ 2 cm increase in abdominal girth)
7 days
Melena/hematochezia
Time Frame: 7 days
Proportion of participants with melena/hematochezia
7 days
Skin rash
Time Frame: 7 days
Proportion of participants with skin rash
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Investigators

  • Study Chair: Safaa H Ali, MD, PhD, Sohag University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 24, 2023

Primary Completion (Anticipated)

May 1, 2024

Study Completion (Anticipated)

May 10, 2024

Study Registration Dates

First Submitted

April 12, 2023

First Submitted That Met QC Criteria

April 12, 2023

First Posted (Actual)

April 25, 2023

Study Record Updates

Last Update Posted (Actual)

April 26, 2023

Last Update Submitted That Met QC Criteria

April 24, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Soh-Med-23-04-16MS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Unidentified individual participant data will be available after publication from the principal investigator upon a reasonable request

IPD Sharing Time Frame

After publication and for 3 years

IPD Sharing Access Criteria

Through contacting the principal investigator by email

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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