Ignite Creation Date:
2024-05-06 @ 3:12 PM
Last Modification Date:
2024-10-26 @ 1:44 PM
Study NCT ID:
NCT04551846
Status:
RECRUITING
Last Update Posted:
2023-07-27
First Post:
2020-08-31
Brief Title:
The Influence of Polymeric Versus Oligomeric Enteral Feeding on Tolerance and Nutritional Status in Paediatric Intensive Care
Sponsor:
Brno University Hospital
Organization:
Brno University Hospital
Study Overview
Official Title:
The Influence of Polymeric Versus Oligomeric Enteral Feeding on Tolerance and Nutritional Status in Paediatric Intensive Care Prospective Randomized Trial
Status:
RECRUITING
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Polygomer
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
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 01 ugkgmin in the 48-hours interval from admission in form of bolus administration of polymeric formula 1mlkgdose 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 5day 600 1000 1400 1800 2200 The las gastric decompression is planned ad 2400 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 01 ugkgmin in the 48-hours interval from admission in form of bolus administration of oligomeric formula 1mlkgdose 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 5day 600 1000 1400 1800 2200 The las gastric decompression is planned ad 2400 The aim is to reach energetic goal defined by Schofield equation
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 01 ugkgmin in the 48-hours interval from admission in form of bolus administration of polymeric formula 1mlkgdose 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 5day 600 1000 1400 1800 2200 The las gastric decompression is planned ad 2400 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 01 ugkgmin in the 48-hours interval from admission in form of bolus administration of oligomeric formula 1mlkgdose 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 5day 600 1000 1400 1800 2200 The las gastric decompression is planned ad 2400 The aim is to reach energetic goal defined by Schofield equation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None