Enteral Feeding Intolerance Clinical Trial
— PolygomerOfficial title:
The Influence of Polymeric Versus Oligomeric Enteral Feeding on Tolerance and Nutritional Status in Paediatric Intensive Care: Prospective Randomized Trial
Malnutrition is associated with negative impact on morbidity and mortality of critically ill patients. Therefore, in patients unable of peroral intake, the nutritional support is indicated. The preferred form of nutritional support is enteral, the more natural form, compared to parenteral. The enteral nutrition is cheaper and is associated with better outcomes and lower incidence of associated complications. The intolerance of enteral feeding is common in critically ill patients, and is associated with insufficient energy and protein intake, that could be linked with the complications such aspiration pneumonia. The optimization of enteral feeding tolerance is therefore one of the research priorities. Implementation of feeding protocols is associated with better tolerance. The enteral feeding could be administered as a oligomeric or polymeric formula. The are preliminary data from adult population pointing at better tolerance of oligomeric feeding formula.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | December 31, 2023 |
Est. primary completion date | December 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 1 Month to 20 Years |
Eligibility | Inclusion Criteria: - PICU patients indicated for nutritional support by enteral feeding (gastric or jejunal) Exclusion Criteria: - Enteral feeding contraindicated - Persistent haemodynamic instability - Informed consent not signed - Acute pancreatitis - Recent upper gastrointestinal surgery - Gut perforation - Ileus |
Country | Name | City | State |
---|---|---|---|
Czechia | Brno University Hospital | Brno | South Moravian Region |
Lead Sponsor | Collaborator |
---|---|
Brno University Hospital |
Czechia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The amount of energy delivery at 7th day | The amount of delivered energy at 7th day according to the defined energy goal by derived from Schofield equation | on the 7th day after study inclusion | |
Primary | The amount of protein delivery at 7th day | The amount of protein delivered at 7th day according to the defined protein delivery goal by derived from Schofield equation | on the 7th day after study initiation | |
Secondary | The time needed to achieve the energy target | The time needed to achieve the energy target according to the Schofield equation | in 7 days after study initiation | |
Secondary | The time needed to achieve the protein target | The time needed to achieve the protein target according to the Schofield equation | in 7 days after study initiation | |
Secondary | The daily energy delivery | The daily amount of energy delivery | in 7 days after study initiation | |
Secondary | The daily gastric residual volume | The daily gastric residual volume | in 7 days after study initiation | |
Secondary | The mean gastric residual volume | The mean gastric residual volume | in 7 days after study initiation | |
Secondary | The time to first stool | The time to first stool from study initiation | in 7 days after study initiation | |
Secondary | The daily number of stool | The daily number of stool from study initiation | in 7 days after study initiation | |
Secondary | Nutritional parameters 1 - albumin | albumin plasmatic levels | in 7 days after study initiation | |
Secondary | Nutritional parameters 1 - prealbumin | prealbumin plasmatic levels | in 7 days after study initiation |
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