ICUePICUreNCT06695078
Nutrition in Paediatric Critical Care
An observational study of ICU and Nutrition, run by Australian and New Zealand Intensive Care Research Centre at 11 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 to 18 years
- Conditions the study is for
- ICU, Nutrition, Paediatric
- How many people
- 200 participants
- Where
- 11 sitesin 2 countries
- Study dates
- 7 Jun 2021to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: All children aged under 18 years admitted for >72 hours to participating PICUs during the two-week study recruitment period. Further funding will be sought to continue this study beyond the 2026 data collection period.
Who may be able to join
- All patients </=18 years of age
- Admitted to the PICU after 00:00 on the day of the study period commencement
- Admitted to the PICU for >72 hours
Who cannot join
- Those previously enrolled during the study period (i.e. those re-admitted to PICU)
- Those for end of life care only
- Those admitted for organ donation
Trial locations and contacts
11 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
11 sites in 2 countries
Australia10 sites, 10 recruiting
- Recruiting
Women's and Children's Hospital Adelaide
Adelaide
Andrea McCall, (08) 8161 7233, andrea.mccall@sa.gov.au
- Recruiting
Queensland Children's Hospital
Brisbane
Jemma Woodgate, (07) 3068 1111, Jemma.Woodgate@health.qld.gov.au
- Recruiting
Royal Hobart Hospital
Hobart
Hannah Price, (03) 6166 8308, hannah.price@ths.tas.gov.au
- Recruiting
Monash Children's Hospital
Melbourne
Jacinta Winderlich, +61 3 8572 3003, jacinta.winderlich@monashhealth.org
- Recruiting
The Royal Children's Hospital Melbourne
Melbourne
Jennifer Flanagan, (03) 9345 9300, jennifer.flanagan@rch.org.au
- Recruiting
Perth Children's Hospital
Perth
Tamara Farrell, (08) 6456 2222, tamara.farrell@health.wa.gov.au
- Recruiting
Sunshine Coast Hospital
Sunshine Coast
Jayde McMilan, 07 5202 8694, Jayde.McMillan@health.qld.gov.au
- Recruiting
John Hunter Children's Hospital
Sydney
Samantha Jenkins, 02 4921 3688, samantha.jenkins@health.nsw.gov.au
- Recruiting
Sydney Children's Hopsital
Sydney
Jessica York, (02) 9382 1021, Jessica.Menzies1@health.nsw.gov.au
- Recruiting
The Children's Hospital at Westmead
Sydney
Stephanie Tang, (02) 7825 2225, Stephanie.Tang@health.nsw.gov.au
New Zealand1 site, 1 recruiting
- Recruiting
Starship Children's Hospital
Auckland
Bridget Little, +64 21 918 449, blittle@adhb.govt.nz
About this study
Official title: Nutrition in Paediatric Critical Care: a Bi-national Prospective Cohort Study
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:
- Nutritional outcomes, including route of nutrition support (oral, enteral and/or parenteral), energy and protein prescription and provision, and anthropometric measures
- Patient-centred outcomes, including duration of invasive respiratory support and hospitalisation, and mortality
- Nutrition service delivery in the PICU and ward settings
- Conditions
- ICU, Nutrition, Paediatric
- Being tested
- No Intervention: Observational Cohort
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Intervention: Observational CohortOther
No Intervention: Observational Cohort
What is being measured
The primary outcome is the main question the study is designed to answer.
Energy intake as proportion of estimated requirements
Oral, enteral and parenteral energy intake will be collected and reported as a proportion of estimated requirements; estimation of requirements will be standardised using the Schofield equation and dependent upon the reported phase of critical illness
Measured: Up to day 28 of hospitalization
Secondary outcomes (7)
Protein intake as proportion of estimated requirements
Oral, enteral and parenteral protein intake will be collected and reported as a proportion of estimated requirements; estimated requirements will be standardised and dependent upon reported phase of critical illness
Measured: Up to day 28 of hospitalization
Route of nutrition provision
Data will be collected on route of nutrition provision (oral, enteral or parenteral); enteral route will be categorised according to type of enteral feeding route
Measured: Up to day 28 of hospitalization
Type of nutrition provision (type of diet or oral/enteral feed/formula)
Data will be collected on the type of nutrition provision, in regards to type of diet and the type of formula or feed provided orally or enterally
Measured: Up to day 28 of hospitalization
Anthropometric measures reported as z-scores
Weight and length/height will be collected (and head circumference for children up to 2 years gestational age); these measures will be reported according to WHO growth standard z-score (up to 2 years age) or CDC growth standard z-scores (2 years age and above)
Measured: Up to day 28 of hospitalization
Multidisciplinary nutrition assessment and intervention
Data will be collected on the frequency of nutrition assessment or intervention, including which profession completed the assessment or intervention (i.e. dietetics, medical, nursing or other)
Measured: Up to day 28 of hospitalization
Duration of invasive ventilation
Data will be collected on the duration of invasive ventilation
Measured: Up to day 28 of hospitalization
Duration of PICU and hospital admission
Duration of PICU and overall hospital admission will be collected
Measured: Up to day 28 of hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2024
- Study start7 Jun 2021
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ICUStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Australian and New Zealand Intensive Care Research Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06695078
- Sponsor's protocol ID
- ANZIC-RC/JW001
- Acronym
- ePICUre
- Status last verified
- Nov 2024
- First submitted
- 28 Oct 2024
- Last updated
- 19 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutrition in Paediatric Critical Care: a Bi-national Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT06695078
- Acronym / sponsor ID
- ePICUre / ANZIC-RC/JW001
- Conditions
- ICU, Nutrition, Paediatric
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Australian and New Zealand Intensive Care Research CentreUniversity, hospital or other
- Study start
- 7 Jun 2021 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 19 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Nutritional outcomes, including route of nutrition support (oral, enteral and/or parenteral), energy and protein prescription and provision, and anthropometric measures
- Patient-centred outcomes, including duration of invasive respiratory support and hospitalisation, and mortality
- Nutrition service delivery in the PICU and ward settings
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 0 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- All children aged under 18 years admitted for >72 hours to participating PICUs during the two-week study recruitment period. Further funding will be sought to continue this study beyond the 2026 data collection period.
Key inclusion criteria (3 listed)
- All patients </=18 years of age
- Admitted to the PICU after 00:00 on the day of the study period commencement
- Admitted to the PICU for >72 hours
Key exclusion criteria (3 listed)
- Those previously enrolled during the study period (i.e. those re-admitted to PICU)
- Those for end of life care only
- Those admitted for organ donation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No Intervention: Observational CohortNo Intervention: Observational Cohort | Other | – |
Primary outcome
Energy intake as proportion of estimated requirements
Time frame: Up to day 28 of hospitalization
Oral, enteral and parenteral energy intake will be collected and reported as a proportion of estimated requirements; estimation of requirements will be standardised using the Schofield equation and dependent upon the reported phase of critical illness
7 secondary outcomes
Protein intake as proportion of estimated requirements
Time frame: Up to day 28 of hospitalization
Route of nutrition provision
Time frame: Up to day 28 of hospitalization
Type of nutrition provision (type of diet or oral/enteral feed/formula)
Time frame: Up to day 28 of hospitalization
Anthropometric measures reported as z-scores
Time frame: Up to day 28 of hospitalization
Multidisciplinary nutrition assessment and intervention
Time frame: Up to day 28 of hospitalization
Duration of invasive ventilation
Time frame: Up to day 28 of hospitalization
Duration of PICU and hospital admission
Time frame: Up to day 28 of hospitalization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
11 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ICU and Nutrition, run by Australian and New Zealand Intensive Care Research Centre at 11 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Australia, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Energy intake as proportion of estimated requirements (time frame: Up to day 28 of hospitalization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2024.