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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06695078




Registration number
NCT06695078
Ethics application status
Date submitted
28/10/2024
Date registered
19/11/2024
Date last updated
19/11/2024

Titles & IDs
Public title
Nutrition in Paediatric Critical Care
Scientific title
Nutrition in Paediatric Critical Care: a Bi-national Prospective Cohort Study
Secondary ID [1] 0 0
ANZIC-RC/JW001
Universal Trial Number (UTN)
Trial acronym
ePICUre
Linked study record

Health condition
Health condition(s) or problem(s) studied:
ICU 0 0
Nutrition 0 0
Paediatric 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Other interventions - No Intervention: Observational Cohort

Other interventions: No Intervention: Observational Cohort
No Intervention: Observational Cohort
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Energy intake as proportion of estimated requirements
Timepoint [1] 0 0
Up to day 28 of hospitalization
Secondary outcome [1] 0 0
Protein intake as proportion of estimated requirements
Timepoint [1] 0 0
Up to day 28 of hospitalization
Secondary outcome [2] 0 0
Route of nutrition provision
Timepoint [2] 0 0
Up to day 28 of hospitalization
Secondary outcome [3] 0 0
Type of nutrition provision (type of diet or oral/enteral feed/formula)
Timepoint [3] 0 0
Up to day 28 of hospitalization
Secondary outcome [4] 0 0
Anthropometric measures reported as z-scores
Timepoint [4] 0 0
Up to day 28 of hospitalization
Secondary outcome [5] 0 0
Multidisciplinary nutrition assessment and intervention
Timepoint [5] 0 0
Up to day 28 of hospitalization
Secondary outcome [6] 0 0
Duration of invasive ventilation
Timepoint [6] 0 0
Up to day 28 of hospitalization
Secondary outcome [7] 0 0
Duration of PICU and hospital admission
Timepoint [7] 0 0
Up to day 28 of hospitalization

Eligibility
Key inclusion criteria
1. All patients </=18 years of age
2. Admitted to the PICU after 00:00 on the day of the study period commencement
3. Admitted to the PICU for >72 hours
Minimum age
0 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Those previously enrolled during the study period (i.e. those re-admitted to PICU)
2. Those for end of life care only
3. Those admitted for organ donation

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
7/06/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2027
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Women's and Children's Hospital Adelaide - Adelaide
Recruitment hospital [2] 0 0
Queensland Children's Hospital - Brisbane
Recruitment hospital [3] 0 0
Royal Hobart Hospital - Hobart
Recruitment hospital [4] 0 0
Monash Children's Hospital - Melbourne
Recruitment hospital [5] 0 0
The Royal Children's Hospital Melbourne - Melbourne
Recruitment hospital [6] 0 0
Perth Children's Hospital - Perth
Recruitment hospital [7] 0 0
Sunshine Coast Hospital - Sunshine Coast
Recruitment hospital [8] 0 0
John Hunter Children's Hospital - Sydney
Recruitment hospital [9] 0 0
Sydney Children's Hopsital - Sydney
Recruitment hospital [10] 0 0
The Children's Hospital at Westmead - Sydney
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment postcode(s) [2] 0 0
- Brisbane
Recruitment postcode(s) [3] 0 0
- Hobart
Recruitment postcode(s) [4] 0 0
- Melbourne
Recruitment postcode(s) [5] 0 0
- Perth
Recruitment postcode(s) [6] 0 0
- Sunshine Coast
Recruitment postcode(s) [7] 0 0
- Sydney
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Other
Name
Australian and New Zealand Intensive Care Research Centre
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is a multi-centre prospective cohort study of nutrition in paediatric critical care in Australia and New Zealand. The study is planned to run in parallel with the adult ICU cohort study, NUTRIENT. Two study periods are proposed with the first in late 2024 and the second in 2026. This observational study seeks to determine the following (although not limited to) descriptive outcomes of interest:

1. Nutritional outcomes, including route of nutrition support (oral, enteral and/or parenteral), energy and protein prescription and provision, and anthropometric measures
2. Patient-centred outcomes, including duration of invasive respiratory support and hospitalisation, and mortality
3. Nutrition service delivery in the PICU and ward settings
Trial website
https://clinicaltrials.gov/study/NCT06695078
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06695078