Clinical trial NCT06695078: Nutrition in Paediatric Critical Care
Official title: Nutrition in Paediatric Critical Care: a Bi-national Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: ICU
Nutrition
Paediatric
Lead sponsor: Australian and New Zealand Intensive Care Research Centre
Sponsor class: OTHER
First posted: 2024-11-19
Enrollment: 200
Sex: ALL
Minimum age (years): 0
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

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


Eligibility criteria: 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

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

Primary outcomes:
measure: Energy intake as proportion of estimated requirements
timeFrame: Up to day 28 of hospitalization
Secondary outcomes:
measure: Protein intake as proportion of estimated requirements
timeFrame: Up to day 28 of hospitalization
measure: Route of nutrition provision
timeFrame: Up to day 28 of hospitalization
measure: Type of nutrition provision (type of diet or oral/enteral feed/formula)
timeFrame: Up to day 28 of hospitalization
measure: Anthropometric measures reported as z-scores
timeFrame: Up to day 28 of hospitalization
measure: Multidisciplinary nutrition assessment and intervention
timeFrame: Up to day 28 of hospitalization
measure: Duration of invasive ventilation
timeFrame: Up to day 28 of hospitalization
measure: Duration of PICU and hospital admission
timeFrame: Up to day 28 of hospitalization
Other outcomes:
Locations:
city: Adelaide
country: Australia
facility: Women's and Children's Hospital Adelaide
city: Brisbane
country: Australia
facility: Queensland Children's Hospital
city: Hobart
country: Australia
facility: Royal Hobart Hospital
city: Melbourne
country: Australia
facility: Monash Children's Hospital
city: Melbourne
country: Australia
facility: The Royal Children's Hospital Melbourne
city: Perth
country: Australia
facility: Perth Children's Hospital
city: Sunshine Coast
country: Australia
facility: Sunshine Coast Hospital
city: Sydney
country: Australia
facility: John Hunter Children's Hospital
city: Sydney
country: Australia
facility: Sydney Children's Hopsital
city: Sydney
country: Australia
facility: The Children's Hospital at Westmead
city: Auckland
country: New Zealand
facility: Starship Children's Hospital
Study officials:
References: