Nutrition in Paediatric Critical Care

NCT06695078 | Recruiting

• 1 other identifier: ANZIC-RC/JW001
• Study Type: observational
• Target: 200
• Locations: 2 countries
• Sites: 11

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. 1.Nutritional outcomes, including route of nutrition support (oral, enteral and/or parenteral), energy and protein prescription and provision, and anthropometric measures
2. 2.Patient-centred outcomes, including duration of invasive respiratory support and hospitalisation, and mortality
3. 3.Nutrition service delivery in the PICU and ward settings

Conditions

ICU; Nutrition; Paediatric

Outcome Measures

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

  Up to day 28 of hospitalization

Secondary Outcomes (7)

• Protein intake as proportion of estimated requirements

  Up to day 28 of hospitalization

• Route of nutrition provision

  Up to day 28 of hospitalization

• Type of nutrition provision (type of diet or oral/enteral feed/formula)

  Up to day 28 of hospitalization

• Anthropometric measures reported as z-scores

  Up to day 28 of hospitalization

• Multidisciplinary nutrition assessment and intervention

  Up to day 28 of hospitalization

Interventions

No Intervention: Observational Cohort OTHER

No Intervention: Observational Cohort

Eligibility Criteria

• Age: 0 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Australian and New Zealand Intensive Care Research Centre: lead

Study Sites (11)

Women's and Children's Hospital Adelaide

Adelaide, Australia

RECRUITING

Queensland Children's Hospital

Brisbane, Australia

RECRUITING

Royal Hobart Hospital

Hobart, Australia

RECRUITING

Monash Children's Hospital

Melbourne, Australia

RECRUITING

The Royal Children's Hospital Melbourne

Melbourne, Australia

RECRUITING

Perth Children's Hospital

Perth, Australia

RECRUITING

Sunshine Coast Hospital

Sunshine Coast, Australia

RECRUITING

John Hunter Children's Hospital

Sydney, Australia

RECRUITING

Sydney Children's Hopsital

Sydney, Australia

RECRUITING

The Children's Hospital at Westmead

Sydney, Australia

RECRUITING

Starship Children's Hospital

Auckland, New Zealand

RECRUITING

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2024
• First Posted: November 19, 2024
• Study Start: June 7, 2021
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: November 19, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

AU (10); NZ (1)