No Intervention: Observational Cohort
OtherNo Intervention: Observational Cohort
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NCT Number: NCT06695078
Nutrition in Paediatric Critical Care
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
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Interested in participating?
Request InfoKey information
Conditions
Age range
0 year–18 year
Sex eligibility
All sexes
Study type
Observational
Primary location
Women's and Children's Hospital Adelaide, Adelaide, Australia
Loading trial locations.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- 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
Exclusion criteria
- 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
Treatment and study plan
Primary outcomes
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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
Secondary outcomes
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Protein intake as proportion of estimated requirements
Time frame: Up to day 28 of hospitalization
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
-
Route of nutrition provision
Time frame: Up to day 28 of hospitalization
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
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Type of nutrition provision (type of diet or oral/enteral feed/formula)
Time frame: Up to day 28 of hospitalization
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
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Anthropometric measures reported as z-scores
Time frame: Up to day 28 of hospitalization
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)
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Multidisciplinary nutrition assessment and intervention
Time frame: Up to day 28 of hospitalization
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)
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Duration of invasive ventilation
Time frame: Up to day 28 of hospitalization
Data will be collected on the duration of invasive ventilation
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Duration of PICU and hospital admission
Time frame: Up to day 28 of hospitalization
Duration of PICU and overall hospital admission will be collected
Sponsors and collaborators
Lead sponsor
Australian and New Zealand Intensive Care Research Centre
Other
Registry information
Official study title
Nutrition in Paediatric Critical Care: a Bi-national Prospective Cohort Study
Acronym: ePICUre
Important dates
- Study start
- 2021
- Primary completion
- 2027
- Study completion
- 2027
- First posted
- Nov 19, 2024
- Registry last updated
- Nov 19, 2024
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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