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

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.

Study Overview

• Status: Recruiting
• Conditions: Enteral Feeding Intolerance
• Intervention / Treatment: Dietary supplement: Polymeric enteral feeding; Dietary supplement: Oligomeric enteral feeding

Detailed 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 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.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Milan Kratochvíl, MD. EDIC; Phone Number: +420532234695; Email: kratochvil.milan@fnbrno.cz
• Study Contact Backup: Name: Jozef Klučka, assoc.prof.MD., Ph.D.; Phone Number: +420532234696; Email: klucka.jozef@fnbrno.cz

Study Locations

• Czechia
  • South Moravian Region
    • Brno, South Moravian Region, Czechia, 62500
      • Recruiting
      • Brno University Hospital
      • Contact: Petr Štourač, doc.MD.P.hD.; Phone Number: 00420 532234404; Email: stourac.petr@fnbrno.cz
      • Contact: Jozef Klučka, MD; Phone Number: 00420 532234696; Email: klucka.jozef@fnbrno.cz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 20 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Oligomeric enteral feeding group; Oligomeric enteral nutrition will be administered according to the study protocol	Dietary supplement: Oligomeric enteral feeding; Oligomeric enteral feeding will be administered to the PICU patients; Other Names: Oligomeric enteral formula
Active Comparator: Polymeric enteral feeding group; Polymeric enteral nutrition will be administered according to the study protocol	Dietary supplement: Polymeric enteral feeding; Polymeric enteral feeding will be administered to the PICU patients; Other Names: Polymeric enteral formula

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

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 daily energy delivery	The daily amount of energy 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

Collaborators and Investigators

• Sponsor: Brno University Hospital
• Investigators: Study Chair: Petr Štourač, prof. MD., Ph.D., Faculty of medicince Masaryk University and University Hospital Brno

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2022
• Primary Completion (Estimated): December 31, 2023
• Study Completion (Estimated): December 31, 2023

Study Registration Dates

• First Submitted: August 31, 2020
• First Submitted That Met QC Criteria: September 15, 2020
• First Posted (Actual): September 16, 2020

Study Record Updates

• Last Update Posted (Actual): July 27, 2023
• Last Update Submitted That Met QC Criteria: July 26, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Enteral feeding; Enteral nutrition; Paediatric patient; Oligomeric; Polymeric
• Other Study ID Numbers: KDAR FN Brno 2020/10/2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No