Nutrition in Paediatric Critical Care
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age0-18
SponsorAustralian and New Zealand Intensive Care Research Centre
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
No Intervention: Observational Cohort
Other interventionNo Intervention: Observational Cohort
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
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
Time frame
Up to day 28 of hospitalizationSecondary outcomes
1
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
Time frame
Up to day 28 of hospitalization2
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
Time frame
Up to day 28 of hospitalization3
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
Time frame
Up to day 28 of hospitalization4
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)
Time frame
Up to day 28 of hospitalizationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov