NUTrition therapy in PAEdiatric patients requiring ExtraCorporeal Membrane Oxygenation: Protocol for a prospective observational multisite study (PAENUT ECMO)

INTRODUCTION: Extracorporeal membrane oxygenation (ECMO) provides life-sustaining gas exchange and haemodynamic support for critically ill patients with severe respiratory or circulatory failure. Paediatric patients supported on ECMO often represent the sickest and most vulnerable patients admitted to the paediatric intensive care unit (PICU). Despite an assumption that nutrition is important in paediatric patients receiving ECMO, data informing optimal nutrition intake during ECMO support and its impact on outcomes are scarce, resulting in limited evidence-based guidelines. Our objective is to document current nutrition therapy practices in paediatric patients <18 years of age supported on ECMO in Australia and New Zealand (ANZ). Secondary objectives are to quantify (i) protein and energy delivery and timing of nutrition commencement and (ii) functional feeding, growth, and patient-centred outcomes across hospitalisation and at hospital discharge. METHODS AND ANALYSIS: prospective, multisite, binational, observational study was conducted to describe nutrition prescription and delivery at specific timepoints throughout hospitalisation in critically ill paediatric patients who are supported on ECMO in ANZ. Paediatric patients admitted for ECMO support to any of the seven PICUs in ANZ who provide ECMO will be enrolled. Demographic, clinical, anthropometric, nutritional intake, and outcome data will be collected from the commencement of ECMO, across hospitalisation. Routine clinical dietetic, medical, and nursing care data will be collected. Outcomes of interest include nutrition delivery outcomes, functional feeding, and growth-related outcomes and clinical outcomes. Results will be presented using descriptive statistics. Preplanned exploratory subgroup analyses will also be conducted. ETHICS AND DISSEMINATION: Ethical approval has been granted by Children's Health Queensland Human Research Ethics Committee (HREC/2024/QCHQ/105788; Australian sites) and Northern B Health and Disability Ethics Committee (2024 EXP 20073; New Zealand site). The project is endorsed by the Australian and New Zealand Intensive Care Society Paediatric Study Group (the binational PICU research network). A partnership has been established with the father of an infant who received ECMO. As a consumer partner, he has provided input in the design phase of the study. Open-access publication in high-impact peer-reviewed journals will be sought along with modern dissemination strategies, such as social media, to disseminate study results. PROTOCOL VERSION/DATE: V1.2/17 Oct 2024.