PRotein Optimization With eXercise to Improve MUscle Mass and Functional outcomeS

Completed · Not applicable

Conditions studied: Muscle Loss, Protein, Mobility, Pediatric ALL

In brief

The investigators have designed a 2-center, pilot feasibility, randomized controlled trial (PROXIMUS) to determine the feasibility and safety of a larger multi center, randomized open-label trial comparing high protein combined with individualized exercise vs. standard management during the acute phase of critical illness in children. The investigators aim to determine the impact of the intervention on preservation of muscle mass; and functional status at 1 month and 6 months after randomization.

Key facts

Study ID: NCT05296096
Run by: Boston Children's Hospital
People needed: 18
Starts: 2023-02-20
Expected to finish: 2026-01-01
Last updated by the study team: 2026-05-29

Who can join

Age: 1 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

ICU patients aged 1 year (corrected) to <18 years
Require mechanical ventilation (endotracheal intubation or tracheostomy, or initiation of noninvasive ventilation) in the first 72 hours of PICU admission.
Able to consent to participate within 72 hours of initiation of mechanical ventilation initiation.

You may not qualify if…

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.

Where it is running

Johns Hopkins Hospital — Baltimore, Maryland, United States
Boston Children's Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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