Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000290897
Ethics application status
Approved
Date submitted
11/02/2021
Date registered
16/03/2021
Date last updated
23/02/2024
Date data sharing statement initially provided
16/03/2021
Date results information initially provided
24/08/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
ePICUre - Nutrition in paediatric critical care: a bi-national multi-centre prospective observational study
Scientific title
ePICUre - Nutrition in paediatric critical care: a bi-national multi-centre prospective observational study
Secondary ID [1] 303427 0
Nil
Universal Trial Number (UTN)
Trial acronym
ePICUre
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Nutrition in paediatric critical illness 320726 0
Nutrition 320727 0
Condition category
Condition code
Diet and Nutrition 318569 318569 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This prospective observational study will investigate the nutritional status and nutrition management of critically ill children until discharge from hospital.
There will be no involvement required with participants. Only routinely recorded data will be collected from the medical records.
The observational period will include from Day 1 of PICU admission to Study Day 28 or discharge from hospital, whichever comes first.
Pending further funding and stakeholder approval, a second study period may be held in 2023.
Intervention code [1] 319731 0
Not applicable
Comparator / control treatment
Comparison groups include:
- Malnourished versus nourished (as determined by anthropometry)
- Early enteral nutrition versus late enteral nutrition
- Primary diagnosis groups
Control group
Active

Outcomes
Primary outcome [1] 326523 0
Difference in length of hospital stay
Timepoint [1] 326523 0
Data will be collected from medical records from day 1 of PICU admission for those eligible until discharge from hospital (or after study day 28, whichever occurs first) and reported separately for groups according to nutritional status and nutrition management.
Secondary outcome [1] 391776 0
Difference in mortality
Timepoint [1] 391776 0
Data will be collected from medical records from day 1 of PICU admission for those eligible until discharge from hospital (or after study day 28, whichever occurs first) and reported separately for groups according to nutritional status and nutrition management.
Secondary outcome [2] 392799 0
Difference in PICU length of stay
Timepoint [2] 392799 0
Data will be collected from medical records from day 1 of PICU admission for those eligible until discharge from hospital (or after study day 28, whichever occurs first) and reported separately for groups according to nutritional status and nutrition management.
Secondary outcome [3] 392800 0
Difference in PICU re-admissions during hospital admission
Timepoint [3] 392800 0
Data will be collected from medical records from day 1 of PICU admission for those eligible until discharge from hospital (or after study day 28, whichever occurs first) and reported separately for groups according to nutritional status and nutrition management.
Secondary outcome [4] 392801 0
Difference in duration of invasive ventilation
Timepoint [4] 392801 0
Data will be collected from medical records from day 1 of PICU admission for those eligible until discharge from hospital (or after study day 28, whichever occurs first) and reported separately for groups according to nutritional status and nutrition management.

Eligibility
Key inclusion criteria
Age 18 years and under
Admitted to the PICU for >48 hours
Minimum age
No limit
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Previously enrolled during the study period
For comfort measures only
Admitted for organ donation

Study design
Purpose
Natural history
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
3/05/2021
Actual
7/06/2021
Date of last participant enrolment
Anticipated
Actual
20/06/2021
Date of last data collection
Anticipated
Actual
1/12/2021
Sample size
Target
100
Accrual to date
Final
141
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,WA,VIC
Recruitment outside Australia
Country [1] 23460 0
New Zealand
State/province [1] 23460 0

Funding & Sponsors
Funding source category [1] 307848 0
University
Name [1] 307848 0
Monash University
Country [1] 307848 0
Australia
Primary sponsor type
University
Name
Monash University - SPHPM
Address
The Australian and New Zealand Intensive Care Research Centre
School of Public Health and Preventive Medicine
Monash University Level 3
553 St Kilda Road Melbourne
Victoria 3004
AUSTRALIA
Country
Australia
Secondary sponsor category [1] 308555 0
None
Name [1] 308555 0
Address [1] 308555 0
Country [1] 308555 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307852 0
Monash Health HREC
Ethics committee address [1] 307852 0
Research Support Services
Level 2, i Block,
Monash Medical Centre
246 Clayton Road
CLAYTON VIC 3168
Ethics committee country [1] 307852 0
Australia
Date submitted for ethics approval [1] 307852 0
16/09/2020
Approval date [1] 307852 0
18/03/2021
Ethics approval number [1] 307852 0
RES-20-0000-705A

Summary
Brief summary
ePICUre is a multi-centre, observational study of nutrition in critically ill children across Australia and New Zealand.

The study will review nutrition practices and resources in participating tertiary PICUs, and the nutritional status, management and associated outcomes for children aged 18 years and under admitted to the PICUs for >48 hours.


Primary Aim:
To develop a platform to study nutrition in critically ill children in Australia and New Zealand that will inform paediatric nutrition care and research.


Objectives:
Primary
1. To profile paediatric critical care nutrition management resources and practice in ANZ
2. To describe the nutritional status of children in ANZ PICUs
3. To better understand nutrition prescription and delivery in ANZ PICUs
4. To provide a benchmarking opportunity for nutrition practice in ANZ PICUs and provide participating sites with data to support quality improvement
5. To provide basic information to inform future paediatric critical care nutrition research questions and priorities

Secondary
6. To identify associations between nutrition and patient outcomes in ANZ PICUs
7. To compare change in nutrition practice between the two proposed study time points



Rationale:
Further research is required to better understand the role of nutrition in paediatric critical care. Undernutrition has been found to be associated with poor clinical outcomes due to detrimental effects including impaired immune function, increased gut permeability and bacterial translocation, and impaired respiratory muscle function. The associated consequences of undernutrition include increased duration of mechanical ventilation, length of stay and mortality. In order to best determine future research directions, the nutritional status and nutrition management of this cohort must be described. Three large international studies of nutrition in paediatric critical care have been undertaken since 2009 however Australian and New Zealand Paediatric Intensive Care Units have not been widely represented.
Trial website
https://www.monash.edu/medicine/sphpm/anzicrc/research/anzic-rc-nutrition-program/epicure
Trial related presentations / publications
https://www.sciencedirect.com/science/article/pii/S0899900723002897

https://www.sciencedirect.com/science/article/pii/S1036731423000371
Public notes

Contacts
Principal investigator
Name 108706 0
Ms Jacinta Winderlich
Address 108706 0
Australian and New Zealand Intensive Care Research Centre,
Public Health and Preventive Medicine
Monash University
Level 3, 553 St Kilda Rd
Melbourne VIC 3004
Country 108706 0
Australia
Phone 108706 0
+61 3 9905 6643
Fax 108706 0
Email 108706 0
jacinta.winderlich@monash.edu
Contact person for public queries
Name 108707 0
Ms Jacinta Winderlich
Address 108707 0
Australian and New Zealand Intensive Care Research Centre,
Public Health and Preventive Medicine
Monash University
Level 3, 553 St Kilda Rd
Melbourne VIC 3004
Country 108707 0
Australia
Phone 108707 0
+61 3 9905 6643
Fax 108707 0
Email 108707 0
jacinta.winderlich@monash.edu
Contact person for scientific queries
Name 108708 0
Ms Jacinta Winderlich
Address 108708 0
Australian and New Zealand Intensive Care Research Centre,
Public Health and Preventive Medicine
Monash University
Level 3, 553 St Kilda Rd
Melbourne VIC 3004
Country 108708 0
Australia
Phone 108708 0
+61 3 9905 6643
Fax 108708 0
Email 108708 0
jacinta.winderlich@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Winderlich J et al., Dietitian and nutrition-relat... [More Details]
Study results articleYes https://www.sciencedirect.com/science/article/pii/... [More Details]

Documents added automatically
No additional documents have been identified.