Nutrition in Paediatric Critical Care (ePICUre)

November 17, 2024 updated by: Australian and New Zealand Intensive Care Research Centre

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:

  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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Up to day 28 of hospitalization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Up to day 28 of hospitalization
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
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
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
Up to day 28 of hospitalization
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)
Up to day 28 of hospitalization
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)
Up to day 28 of hospitalization
Duration of invasive ventilation
Time Frame: Up to day 28 of hospitalization
Data will be collected on the duration of invasive ventilation
Up to day 28 of hospitalization
Duration of PICU and hospital admission
Time Frame: Up to day 28 of hospitalization
Duration of PICU and overall hospital admission will be collected
Up to day 28 of hospitalization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Australian and New Zealand Intensive Care Research Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 7, 2021

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

October 28, 2024

First Submitted That Met QC Criteria

November 17, 2024

First Posted (Estimated)

November 19, 2024

Study Record Updates

Last Update Posted (Estimated)

November 19, 2024

Last Update Submitted That Met QC Criteria

November 17, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • ANZIC-RC/JW001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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