Table 3

Study outcomes

Primary feasibility outcomes


Proportion of eligible patients approached for consent
Proportion of participants receiving their first protein supplementation within 72 hours of enrolment
Participant accrual, defined as an average monthly enrolment of at least one participant per centre
Protocol adherence, defined as >80% of protein target administered according to the protocol in the intervention arm
Secondary clinical outcomes






PICU mortality
PICU LOS
28-day PICU-free days
Hospital LOS
MV duration
28-day ventilator-free days
Development of AEs including feeding intolerance, diarrhoea, GI bleeding, and treatment used for GI bleeding
Change in muscle size (eg, ultrasound guided cross-sectional area of the rectus femoris, diaphragm thickness) during PICU stay, at PICU discharge, hospital discharge and 6 months later
Change in anthropometric measurements (height, weight, BMI) at PICU discharge, hospital discharge and 6 months later
Change in functional status (PEDI-CAT score, FSS score, hand-grip strength and 6-minute walk test) at hospital discharge and 6 months later
  • AE, adverse effects; BMI, body mass index; FSS, Functional Status Score; GI, gastrointestinal; LOS, length of stay; MV, mechanical ventilation; PEDI-CAT, Paediatric Evaluation of Disability Inventory—Computer Adaptive Test; PICU, paediatric intensive care unit.