ANZCTR - Registration

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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

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]

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

Nutrition

Condition category

Condition code

Diet and Nutrition

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]

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]

Difference in length of hospital stay

Timepoint [1]

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]

Difference in mortality

Timepoint [1]

Secondary outcome [2]

Difference in PICU length of stay

Timepoint [2]

Secondary outcome [3]

Difference in PICU re-admissions during hospital admission

Timepoint [3]

Secondary outcome [4]

Difference in duration of invasive ventilation

Timepoint [4]

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?

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]

New Zealand

State/province [1]

Funding & Sponsors

Funding source category [1]

University

Name [1]

Monash University

Address [1]

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 [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Monash Health HREC

Ethics committee address [1]

Research Support Services
Level 2, i Block,
Monash Medical Centre
246 Clayton Road
CLAYTON VIC 3168

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

16/09/2020

Approval date [1]

18/03/2021

Ethics approval number [1]

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

Ms Jacinta Winderlich

Address

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

Australia

Phone

+61 3 9905 6643

Fax

[email protected]

Contact person for public queries

Name

Jacinta Winderlich

Address

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

Australia

Phone

+61 3 9905 6643

Fax

[email protected]

Contact person for scientific queries

Name

Jacinta Winderlich

Address

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

Australia

Phone

+61 3 9905 6643

Fax

[email protected]

Data sharing statement

Will the study consider sharing individual participant data?

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.

Trial Review

Documents added manually

Documents added automatically