The Influence of Polymeric Versus Oligomeric Enteral Feeding on Tolerance and Nutritional Status in Paediatric Intensive Care
NCT ID: NCT04551846
Last Updated: 2023-07-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
200 participants
INTERVENTIONAL
2022-06-01
2023-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Oligomeric enteral feeding group
Oligomeric enteral nutrition will be administered according to the study protocol
Oligomeric enteral feeding
Oligomeric enteral feeding will be administered to the PICU patients
Polymeric enteral feeding group
Polymeric enteral nutrition will be administered according to the study protocol
Polymeric enteral feeding
Polymeric enteral feeding will be administered to the PICU patients
Interventions
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Oligomeric enteral feeding
Oligomeric enteral feeding will be administered to the PICU patients
Polymeric enteral feeding
Polymeric enteral feeding will be administered to the PICU patients
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Persistent haemodynamic instability
* Informed consent not signed
* Acute pancreatitis
* Recent upper gastrointestinal surgery
* Gut perforation
* Ileus
1 Month
20 Years
ALL
No
Sponsors
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Brno University Hospital
OTHER
Responsible Party
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Petr Štourač, MD
Clinical Professor
Principal Investigators
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Petr Štourač, prof. MD., Ph.D.
Role: STUDY_CHAIR
Faculty of medicince Masaryk University and University Hospital Brno
Locations
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Brno University Hospital
Brno, South Moravian, Czechia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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KDAR FN Brno 2020/10/2
Identifier Type: -
Identifier Source: org_study_id
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