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

Enteral Feeding Intolerance Clinical Trial

— Polygomerpilot  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05271565
• Other study ID #: KDAR FN Brno 2022/28/2
• Status: Recruiting
• Phase: N/A
• Start date: April 21, 2022
• Est. completion date: August 31, 2023

Study information

• Verified date: February 2023
• Source: Brno University Hospital
• Contact: Jozef Klucka, assoc.prof.MD., Ph.D.
• Phone: +420532234696
• Email: klucka.jozef[@]fnbrno.cz
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: August 31, 2023
• Est. primary completion date: August 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 19 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

Related Conditions & MeSH terms

• Enteral Feeding Intolerance

Intervention

Dietary Supplement:
• Oligomeric enteral feeding
Oligomeric enteral formula
• Polymeric enteral feeding
Polymeric enteral feeding will be administered to the PICU patients

Locations

Country	Name	City	State
Czechia	Brno University Hospital	Brno	South Moravian Region

Sponsors (2)

Lead Sponsor	Collaborator
Brno University Hospital	Masaryk University

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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 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
Secondary	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
Secondary	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
Secondary	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 daily energy delivery	The daily amount of energy delivery	in 7 days after study initiation
Secondary	The daily protein delivery	The daily amount of protein delivery	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 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