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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

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
Trial website
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

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

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06695078