The Influence of Polymeric Versus Oligomeric Enteral Feeding on Tolerance and Nutritional Status in Paediatric Intensive Care Pilot

Study Overview
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Brief Summary
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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.

Detailed Description
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After Ethics Committee approval, all paediatric patients admitted to the paediatric intensive care unit (PICU) will underwent PICU screening. In case of eligible for inclusion in to the study, the baseline parameters a demographics will be evaluated together with the initial laboratory sampling after approval and singed the informed consent by the legal guardian of the patient. Patients will be randomized by the online randomizer to the oligomeric and polymeric enteral nutrition group. Polymeric (control group): Patients indicated for at least 2 days of enteral nutrition by the gastric tube. The nutritional support will be initiated after initial haemodynamic stabilization (blood levels of lactate normalization, norepinephrine infusion <0,1 ug/kg/min) in the 48-hours interval from admission in form of bolus administration of polymeric formula. The initial dose will be 10% of the target volume (by Schofield equation). The gastric residual volume will be evaluated after 4 hours from bolus dose. In case of gastric residual volume lower than half of previously administered dose, the next dose will be elevated by 10% with the aim to reach the target dose in 48 hours. In case of higher residual volume, the same amount will be administered with the metoclopramid (3 times per day). In case of persistent residual volume higher than half of initial dose in 12 hours, the erythromycin will be initiated for 3 days. The bolus enteral feeding will be administered at the predefined time 5/day (6:00, 10:00, 14:00, 18:00, 22:00). The last gastric decompression is planned ad 24:00. The aim is to reach energetic goal defined by Schofield equation. Interventional (oligomeric group): Patients indicated for at least 2 days of enteral nutrition by the gastric tube. The nutritional support will be initiated after initial haemodynamic stabilization (blood levels of lactate normalization, norepinephrine infusion <0,1 ug/kg/min) in the 48-hours interval from admission in form of bolus administration of oligomeric formula. The initial dose will be 10% of the target volume (by Schofield equation). The gastric residual volume will be evaluated after 4 hours from bolus dose. In case of gastric residual volume lower than half of previously administered dose, the next dose will be elevated by 10% with the aim to reach the target dose in 48 hours. In case of higher residual volume, the same amount will be administered with the metoclopramid (3 times per day). In case of persistent residual volume higher than half of initial dose in 12 hours, the erythromycin will be initiated for 3 days. The bolus enteral feeding will be administered at the predefined time 5/day (6:00, 10:00, 14:00, 18:00, 22:00). The las gastric decompression is planned ad 24:00. The aim is to reach energetic goal defined by Schofield equation.

Official Title
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The Influence of Polymeric Versus Oligomeric Enteral Feeding on Tolerance and Nutritional Status in Paediatric Intensive Care: Prospective Randomized Pilot Trial

Conditions
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Enteral Feeding Intolerance

Intervention / Treatment
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* Dietary Supplement: Oligomeric enteral feeding
* Dietary Supplement: Polymeric enteral feeding


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Monocentric randomized pilot controlled trial with 2 groups: interventional (oligomeric formula) and control (polymeric)
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oligomeric enteral feeding group<br>Oligomeric enteral nutrition will be administered according to the study protocol | Dietary Supplement: Oligomeric enteral feeding<br>* Oligomeric enteral formula<br>* Other names: Oligomeric enteral feeding will be administered to the PICU patients;|
| Active Comparator: Polymeric enteral feeding group<br>Polymeric enteral nutrition will be administered according to the study protocol | Dietary Supplement: Polymeric enteral feeding<br>* Polymeric enteral feeding will be administered to the PICU patients<br>* Other names: Polymeric enteral formula;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The amount of energy delivery at 3rd day | The amount of delivered energy at 3rd day according to the defined energy goal by derived from Schofield equation (defined after 15 enteral bolus doses) | on the 3rd day after study inclusion | 
| The amount of protein delivery at 3rd day | The amount of delivered protein at 3rd day according to the defined protein goal by derived from Schofield equation (defined after 15 enteral bolus doses) | on the 3rd day after study inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| The amount of energy delivery at 5th day | The amount of delivered energy at 5th day according to the defined energy goal by derived from Schofield equation | on the 5th day after study inclusion | 
| The amount of protein delivery at 5th day | The amount of protein delivered at 5th day according to the defined protein delivery goal by derived from Schofield equation | on the 5th day after study inclusion | 
| 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 | 
| 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 | 
| The daily energy delivery | The daily amount of energy delivery | in 7 days after study initiation | 
| The daily protein delivery | The daily amount of protein delivery | in 7 days after study initiation | 
| 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 | 
| The daily gastric residual volume | The daily gastric residual volume | in 7 days after study initiation | 
| The mean gastric residual volume | The mean gastric residual volume | in 7 days after study initiation | 
| The time to first stool | The time to first stool from study initiation | in 7 days after study initiation | 
| The daily number of stool | The daily number of stool from study initiation | in 7 days after study initiation | 
| Nutritional parameters 1 - albumin | albumin plasmatic levels | in 7 days after study initiation | 
| Nutritional parameters 1 - prealbumin | prealbumin plasmatic levels | in 7 days after study initiation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Enteral feeding, Enteral nutrition, Paediatric patient, Oligomeric, Polymeric