An interventional study of Oligomeric enteral feeding and Polymeric enteral feeding in Enteral Feeding Intolerance, sponsored by Brno University Hospital. Recruiting at 1 site in Czechia. Open to participants aged 1 Month to 20 Years. Per ClinicalTrials.gov, last updated 2023-07-27.
Sponsored by Brno University Hospital · Not applicable, Interventional, and Treatment
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.
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 1ml/kg/dose. 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 doubled. 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.
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 1ml/kg/dose. 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 doubled. 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.
Brno University Hospital is the lead sponsor of 91 studies on the registry; 22 are open to participants now.
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Exclusion Criteria:
Oligomeric enteral nutrition will be administered according to the study protocol
Dietary Supplement: Oligomeric enteral feeding
Polymeric enteral nutrition will be administered according to the study protocol
Dietary Supplement: Polymeric enteral feeding
Oligomeric enteral feeding will be administered to the PICU patients
Also known as: Oligomeric enteral formula
Polymeric enteral feeding will be administered to the PICU patients
Also known as: Polymeric enteral formula
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
Time frame: 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
Time frame: on the 7th day after study initiation
The time needed to achieve the energy target
The time needed to achieve the energy target according to the Schofield equation
Time frame: 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
Time frame: in 7 days after study initiation
The daily energy delivery
The daily amount of energy delivery
Time frame: in 7 days after study initiation
The daily gastric residual volume
The daily gastric residual volume
Time frame: in 7 days after study initiation
The mean gastric residual volume
The mean gastric residual volume
Time frame: in 7 days after study initiation
The time to first stool
The time to first stool from study initiation
Time frame: in 7 days after study initiation
The daily number of stool
The daily number of stool from study initiation
Time frame: in 7 days after study initiation
Nutritional parameters 1 - albumin
albumin plasmatic levels
Time frame: in 7 days after study initiation
Nutritional parameters 1 - prealbumin
prealbumin plasmatic levels
Time frame: in 7 days after study initiation
Plan to share: Undecided
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Brno University Hospital