Enteral Feeding IntolerancePolygomerNCT04551846
The Influence of Polymeric Versus Oligomeric Enteral Feeding on Tolerance and Nutritional Status in Paediatric Intensive Care
A study testing Oligomeric enteral feeding and Polymeric enteral feeding in people with Enteral Feeding Intolerance, run by Brno University Hospital at 1 site in Czechia.
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. Read more about this study
- Who is it for?
- Ages 1 month to 20 years
- Conditions the study is for
- Enteral Feeding Intolerance
- What is being tested?
- Oligomeric enteral feeding and Polymeric enteral feeding
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Jun 2022to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- PICU patients indicated for nutritional support by enteral feeding (gastric or jejunal)
Who cannot join
- Enteral feeding contraindicated
- Persistent haemodynamic instability
- Informed consent not signed
- Acute pancreatitis
- Recent upper gastrointestinal surgery
- Gut perforation
- Ileus
Trial locations and contacts
1 site in 1 country.
Czechia1 site, 1 recruiting
- Recruiting
Brno University Hospital
Brno, South Moravian, 62500
Petr Štourač, doc.MD.P.hD., 532234404 ext. 00420, stourac.petr@fnbrno.cz
Jozef Klučka, MD, 532234696 ext. 00420, klucka.jozef@fnbrno.cz
About this study
Official title: 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.
Read the 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.
- Conditions
- Enteral Feeding Intolerance
- Being tested
- Oligomeric enteral feeding, Polymeric enteral feeding
- Keywords
- Enteral feeding, Enteral nutrition, Paediatric patient, Oligomeric, Polymeric
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oligomeric enteral feedingDietary supplement
Also called Oligomeric enteral formula
Oligomeric enteral feeding will be administered to the PICU patients
Polymeric enteral feedingDietary supplement
Also called Polymeric enteral formula
Polymeric enteral feeding will be administered to the PICU patients
| Study group | Role | What they receive |
|---|---|---|
| Oligomeric enteral feeding group | Experimental | Oligomeric enteral nutrition will be administered according to the study protocol Receives: Dietary Supplement: Oligomeric enteral feeding |
| Polymeric enteral feeding group | Active comparator | Polymeric enteral nutrition will be administered according to the study protocol Receives: Dietary Supplement: Polymeric enteral feeding |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: on the 7th day after study initiation
Secondary outcomes (9)
The time needed to achieve the energy target
The time needed to achieve the energy target according to the Schofield equation
Measured: 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
Measured: in 7 days after study initiation
The daily energy delivery
The daily amount of energy delivery
Measured: in 7 days after study initiation
The daily gastric residual volume
The daily gastric residual volume
Measured: in 7 days after study initiation
The mean gastric residual volume
The mean gastric residual volume
Measured: in 7 days after study initiation
The time to first stool
The time to first stool from study initiation
Measured: in 7 days after study initiation
The daily number of stool
The daily number of stool from study initiation
Measured: in 7 days after study initiation
Nutritional parameters 1 - albumin
albumin plasmatic levels
Measured: in 7 days after study initiation
Nutritional parameters 1 - prealbumin
prealbumin plasmatic levels
Measured: in 7 days after study initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2020
- Study start1 Jun 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Enteral Feeding IntoleranceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Monocentric randomized controlled trial with 2 groups: interventional (oligomeric formula) and control (polymeric)
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brno University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Petr Štourač, MD, Brno University Hospital
- Investigators
- Petr Štourač, prof. MD., Ph.D., Study chair, Faculty of medicince Masaryk University and University Hospital Brno
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04551846
- Sponsor's protocol ID
- KDAR FN Brno 2020/10/2
- Acronym
- Polygomer
- Status last verified
- Jul 2023
- First submitted
- 31 Aug 2020
- Last updated
- 27 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Polymeric Versus Oligomeric Enteral Feeding on Tolerance and Nutritional Status in Paediatric Intensive Care: Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT04551846
- Acronym / sponsor ID
- Polygomer / KDAR FN Brno 2020/10/2
- Conditions
- Enteral Feeding Intolerance
- Keywords
- Enteral feeding, Enteral nutrition, Paediatric patient, Oligomeric, Polymeric
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Brno University HospitalUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 16 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Monocentric randomized controlled trial with 2 groups: interventional (oligomeric formula) and control (polymeric)
| Arm | Type | Receives |
|---|---|---|
| Oligomeric enteral feeding group | Experimental | Dietary Supplement: Oligomeric enteral feedingOligomeric enteral nutrition will be administered according to the study protocol |
| Polymeric enteral feeding group | Active comparator | Dietary Supplement: Polymeric enteral feedingPolymeric enteral nutrition will be administered according to the study protocol |
Who may qualify
- Ages
- 1 month to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- PICU patients indicated for nutritional support by enteral feeding (gastric or jejunal)
Key exclusion criteria (7 listed)
- Enteral feeding contraindicated
- Persistent haemodynamic instability
- Informed consent not signed
- Acute pancreatitis
- Recent upper gastrointestinal surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oligomeric enteral feedingAlso: Oligomeric enteral formulaOligomeric enteral feeding will be administered to the PICU patients | Dietary supplement | Oligomeric enteral feeding group |
| Polymeric enteral feedingAlso: Polymeric enteral formulaPolymeric enteral feeding will be administered to the PICU patients | Dietary supplement | Polymeric enteral feeding group |
Primary outcome
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
9 secondary outcomes
The time needed to achieve the energy target
Time frame: in 7 days after study initiation
The time needed to achieve the protein target
Time frame: in 7 days after study initiation
The daily energy delivery
Time frame: in 7 days after study initiation
The daily gastric residual volume
Time frame: in 7 days after study initiation
The mean gastric residual volume
Time frame: in 7 days after study initiation
The time to first stool
Time frame: in 7 days after study initiation
The daily number of stool
Time frame: in 7 days after study initiation
Nutritional parameters 1 - albumin
Time frame: in 7 days after study initiation
Nutritional parameters 1 - prealbumin
Time frame: in 7 days after study initiation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
- Individual participant dataSharing planned: Undecided
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Patients Who Receive Enteral Nutrition for at Least 72 Hours in the Intensive Care Unit Will be Included in the Study
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Not yet recruitingObservational study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Petr Štourač, prof. MD., Ph.D. study chair
Faculty of medicince Masaryk University and University Hospital Brno
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oligomeric enteral feeding and Polymeric enteral feeding in people with Enteral Feeding Intolerance, run by Brno University Hospital at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jozef Klučka, assoc.prof.MD., Ph.D. (+420532234696, klucka.jozef@fnbrno.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The amount of energy delivery at 7th day (time frame: on the 7th day after study inclusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2023.