NCT04551846

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 31, 2020

Completed
16 days until next milestone

First Posted

Study publicly available on registry

September 16, 2020

Completed
1.7 years until next milestone

Study Start

First participant enrolled

June 1, 2022

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

July 27, 2023

Status Verified

July 1, 2023

Enrollment Period

1.6 years

First QC Date

August 31, 2020

Last Update Submit

July 26, 2023

Conditions

Enteral Feeding Intolerance

Keywords

Enteral feedingEnteral nutritionPaediatric patientOligomericPolymeric

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (9)

  • The time needed to achieve the energy target

    in 7 days after study initiation

  • The time needed to achieve the protein target

    in 7 days after study initiation

  • The daily energy delivery

    in 7 days after study initiation

  • The daily gastric residual volume

    in 7 days after study initiation

  • The mean gastric residual volume

    in 7 days after study initiation

  • +4 more secondary outcomes

Study Arms (2)

Oligomeric enteral feeding group

EXPERIMENTAL

Oligomeric enteral nutrition will be administered according to the study protocol

Dietary Supplement: Oligomeric enteral feeding

Polymeric enteral feeding group

ACTIVE COMPARATOR

Polymeric enteral nutrition will be administered according to the study protocol

Dietary Supplement: Polymeric enteral feeding

Interventions

Oligomeric enteral feedingDIETARY_SUPPLEMENT

Oligomeric enteral feeding will be administered to the PICU patients

Also known as: Oligomeric enteral formula
Oligomeric enteral feeding group
Polymeric enteral feedingDIETARY_SUPPLEMENT

Polymeric enteral feeding will be administered to the PICU patients

Also known as: Polymeric enteral formula
Polymeric enteral feeding group

Eligibility Criteria

Age1 Month - 20 Years
Sexall(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • PICU patients indicated for nutritional support by enteral feeding (gastric or jejunal)

You may not qualify if:

  • Enteral feeding contraindicated
  • Persistent haemodynamic instability
  • Informed consent not signed
  • Acute pancreatitis
  • Recent upper gastrointestinal surgery
  • Gut perforation
  • Ileus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brno University Hospital

Brno, South Moravian, 62500, Czechia

RECRUITING

Study Officials

  • Petr Štourač, prof. MD., Ph.D.

    Faculty of medicince Masaryk University and University Hospital Brno

    STUDY CHAIR

Central Study Contacts

Jozef Klučka, assoc.prof.MD., Ph.D.

CONTACT

+420532234696klucka.jozef@fnbrno.cz

Milan Kratochvíl, MD. EDIC

CONTACT

+420532234695kratochvil.milan@fnbrno.cz

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
The patients and the legal guardians will be blinded
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Monocentric randomized controlled trial with 2 groups: interventional (oligomeric formula) and control (polymeric)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

August 31, 2020

First Posted

September 16, 2020

Study Start

June 1, 2022

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

July 27, 2023

Record last verified: 2023-07

Locations

CZ(1)