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 provided
23/02/2024
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
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
Trial website
Trial related presentations / publications
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
[email protected]
Contact person for public queries
Name 108707 0
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
[email protected]
Contact person for scientific queries
Name 108708 0
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
[email protected]

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
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.