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

Overview

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.

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

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Primary Purpose: Treatment
  • Masking: Single (Participant)
• Study Primary Completion Date: August 31, 2023

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. 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.

Interventions

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

Arms, Groups and Cohorts

• Experimental: Oligomeric enteral feeding group
  • Oligomeric enteral nutrition will be administered according to the study protocol
• Active Comparator: Polymeric enteral feeding group
  • Polymeric enteral nutrition will be administered according to the study protocol

Clinical Trial Outcome Measures

Primary Measures

• The amount of energy delivery at 3rd day
  • Time Frame: on the 3rd day after study inclusion
  • 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)
• The amount of protein delivery at 3rd day
  • Time Frame: on the 3rd day after study inclusion
  • 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)

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 1 Month

Maximum Age: 19 Years

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • Brno University Hospital
• Collaborator
  • Masaryk University
• Provider of Information About this Clinical Study
  • Principal Investigator: Petr Štourač, MD, Clinical Professor – Brno University Hospital
• Overall Official(s)
  • Petr Stourac, prof. MD., Ph.D., MBA, Study Chair, Department of paediatric anaesthesiology and intensive care medicine
• Overall Contact(s)
  • Jozef Klučka, assoc.prof.MD., Ph.D., +420532234696, klucka.jozef@fnbrno.cz