PRotein Optimization With eXercise to Improve MUscle Mass and Functional outcomeS

Launched by BOSTON CHILDREN'S HOSPITAL · Mar 15, 2022

Keywords

ClinConnect Summary

The PRotein Optimization With eXercise to Improve MUscle Mass and Functional outcomeS (PROXIMUS) trial is studying how a combination of high protein intake and personalized exercise can help children who are critically ill preserve their muscle mass and improve their overall functional abilities. This trial involves two medical centers and is looking to see if this approach is safe and effective compared to standard care, especially during the first month and six months after treatment begins.

To be eligible for this study, children aged 1 to 17 who are in intensive care and need help with breathing (like being on a ventilator) within the first 72 hours of their hospital stay can participate. If your child meets these criteria and is able to give consent within that time, they may be able to join. Participants will receive either the high protein and exercise program or standard care and be monitored for their muscle health and mobility over time. It’s important to know that some children may not qualify if they have certain serious medical conditions or are on specific diets. This study aims to provide valuable information that could lead to better care for critically ill children in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. ICU patients aged 1 year (corrected) to \<18 years
• • 2. Require mechanical ventilation (endotracheal intubation or tracheostomy, or initiation of noninvasive ventilation) in the first 72 hours of PICU admission.
• • 3. Able to consent to participate within 72 hours of initiation of mechanical ventilation initiation.
• Exclusion Criteria:
• • Patients unable to receive EN, PN, or who are on a specialized diet incompatible with the study intervention
• • Fulminant liver failure
• • Kidney failure (≥KDIGO Stage 3) without replacement therapy
• • Functional Status Scale score at PICU admission \<9
• • End of life/redirection of care
• • ECMO therapy
• • Continuous neuromuscular blockade and/or bedrest is medically or surgically necessitated Participation in a conflicting interventional trial
• • High risk of refeeding syndrome
• • Inborn errors of metabolism
• • High BSA burns.