- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05271565
The Influence of Polymeric Versus Oligomeric Enteral Feeding on Tolerance and Nutritional Status in Paediatric Intensive Care Pilot (Polygomerpilot)
The Influence of Polymeric Versus Oligomeric Enteral Feeding on Tolerance and Nutritional Status in Paediatric Intensive Care: Prospective Randomized Pilot Trial
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
South Moravian Region
-
Brno, South Moravian Region, Czechia, 62500
- Recruiting
- Brno University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Oligomeric enteral feeding group
Oligomeric enteral nutrition will be administered according to the study protocol
|
Oligomeric enteral formula
Other Names:
|
ACTIVE_COMPARATOR: Polymeric enteral feeding group
Polymeric enteral nutrition will be administered according to the study protocol
|
Polymeric enteral feeding will be administered to the PICU patients
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
on the 3rd day after study inclusion
|
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)
|
on the 3rd day after study inclusion
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
in 7 days after study initiation
|
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
|
on the 5th day after study inclusion
|
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
|
on the 5th day after study inclusion
|
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
|
on the 7th day after study inclusion
|
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
|
on the 7th day after study initiation
|
The daily energy delivery
Time Frame: in 7 days after study initiation
|
The daily amount of energy delivery
|
in 7 days after study initiation
|
The daily protein delivery
Time Frame: in 7 days after study initiation
|
The daily amount of protein delivery
|
in 7 days after study initiation
|
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
|
in 7 days after study initiation
|
The daily gastric residual volume
Time Frame: in 7 days after study initiation
|
The daily gastric residual volume
|
in 7 days after study initiation
|
The mean gastric residual volume
Time Frame: in 7 days after study initiation
|
The mean gastric residual volume
|
in 7 days after study initiation
|
The time to first stool
Time Frame: in 7 days after study initiation
|
The time to first stool from study initiation
|
in 7 days after study initiation
|
The daily number of stool
Time Frame: in 7 days after study initiation
|
The daily number of stool from study initiation
|
in 7 days after study initiation
|
Nutritional parameters 1 - albumin
Time Frame: in 7 days after study initiation
|
albumin plasmatic levels
|
in 7 days after study initiation
|
Nutritional parameters 1 - prealbumin
Time Frame: in 7 days after study initiation
|
prealbumin plasmatic levels
|
in 7 days after study initiation
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- KDAR FN Brno 2022/28/2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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