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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04551846
Other study ID # KDAR FN Brno 2020/10/2
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 1, 2022
Est. completion date December 31, 2023

Study information

Verified date July 2023
Source Brno University Hospital
Contact Jozef Klucka, assoc.prof.MD., Ph.D.
Phone +420532234696
Email klucka.jozef@fnbrno.cz
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date December 31, 2023
Est. primary completion date December 31, 2023
Accepts healthy volunteers No
Gender All
Age group 1 Month to 20 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
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

Locations

Country Name City State
Czechia Brno University Hospital Brno South Moravian Region

Sponsors (1)

Lead Sponsor Collaborator
Brno University Hospital

Country where clinical trial is conducted

Czechia, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 on the 7th day after study inclusion
Primary 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 on the 7th day after study initiation
Secondary The time needed to achieve the energy target The time needed to achieve the energy target according to the Schofield equation in 7 days after study initiation
Secondary The time needed to achieve the protein target The time needed to achieve the protein target according to the Schofield equation in 7 days after study initiation
Secondary The daily energy delivery The daily amount of energy delivery in 7 days after study initiation
Secondary The daily gastric residual volume The daily gastric residual volume in 7 days after study initiation
Secondary The mean gastric residual volume The mean gastric residual volume in 7 days after study initiation
Secondary The time to first stool The time to first stool from study initiation in 7 days after study initiation
Secondary The daily number of stool The daily number of stool from study initiation in 7 days after study initiation
Secondary Nutritional parameters 1 - albumin albumin plasmatic levels in 7 days after study initiation
Secondary Nutritional parameters 1 - prealbumin prealbumin plasmatic levels in 7 days after study initiation
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