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

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ClinicalTrials.gov Identifier: NCT04551846
Recruitment Status : Not yet recruiting
First Posted : September 16, 2020
Last Update Posted : February 1, 2022
Sponsor:
Information provided by (Responsible Party):
Petr Štourač, MD, Brno University Hospital

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Enteral Feeding Intolerance Dietary Supplement: Oligomeric enteral feeding Dietary Supplement: Polymeric enteral feeding Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Monocentric randomized controlled trial with 2 groups: interventional (oligomeric formula) and control (polymeric)
Masking: Single (Participant)
Masking Description: The patients and the legal guardians will be blinded
Primary Purpose: Treatment
Official Title: The Influence of Polymeric Versus Oligomeric Enteral Feeding on Tolerance and Nutritional Status in Paediatric Intensive Care: Prospective Randomized Trial
Estimated Study Start Date : March 1, 2022
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022
Arms and Interventions
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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 Name: 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 Name: Polymeric enteral formula


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. The daily energy delivery [ Time Frame: in 7 days after study initiation ]
    The daily amount of energy delivery

  4. The daily gastric residual volume [ Time Frame: in 7 days after study initiation ]
    The daily gastric residual volume

  5. The mean gastric residual volume [ Time Frame: in 7 days after study initiation ]
    The mean gastric residual volume

  6. The time to first stool [ Time Frame: in 7 days after study initiation ]
    The time to first stool from study initiation

  7. The daily number of stool [ Time Frame: in 7 days after study initiation ]
    The daily number of stool from study initiation

  8. Nutritional parameters 1 - albumin [ Time Frame: in 7 days after study initiation ]
    albumin plasmatic levels

  9. Nutritional parameters 1 - prealbumin [ Time Frame: in 7 days after study initiation ]
    prealbumin plasmatic levels


Eligibility Criteria
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Ages Eligible for Study:   1 Month to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04551846


Contacts
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Contact: Jozef Klučka, assoc.prof.MD., Ph.D. +420532234696 klucka.jozef@fnbrno.cz
Contact: Milan Kratochvíl, MD. EDIC +420532234695 kratochvil.milan@fnbrno.cz

Locations
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Czechia
Brno University Hospital
Brno, South Moravian Region, Czechia, 62500
Sponsors and Collaborators
Brno University Hospital
Investigators
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Study Chair: Petr Štourač, prof. MD., Ph.D. Faculty of medicince Masaryk University and University Hospital Brno
More Information
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Responsible Party: Petr Štourač, MD, Clinical Professor, Brno University Hospital
ClinicalTrials.gov Identifier: NCT04551846    
Other Study ID Numbers: KDAR FN Brno 2020/10/2
First Posted: September 16, 2020    Key Record Dates
Last Update Posted: February 1, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Petr Štourač, MD, Brno University Hospital:
Enteral feeding
Enteral nutrition
Paediatric patient
Oligomeric
Polymeric