RECRUITINGINTERVENTIONAL

PRotein Optimization With eXercise to Improve MUscle Mass and Functional outcomeS

PRotein Optimization With eXercise to Improve MUscle Mass and Functional outcomeS - a Pilot Feasibility, Randomized Controlled Trial

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: 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. Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

OTHER

Protein dosage and rehabilitation team delivered exercise prescription

The dietitian and rehabilitation team will be consulted on enrollment and will assess the patient for nutritional and functional status using the institutional criteria and physical exam. The study dietitian will prescribe the protein goal based on the randomization assignment and age group. For the high protein arm, protein goals will be 3g/kg/day for ages 1-1yrs, and 2.4g/kg/day for ages greater than 12 years. The rehabilitation team will determine the appropriate highest level of mobility (HLM) for the day in collaboration with the medical team on morning rounds. The rehabilitation team will prescribe passive or active participation in two 30-minute HLM sessions, individualized to their baseline function and clinical status and/or restrictions.

Locations (2)

Johns Hopkins Hospital

Baltimore, Maryland, United States

Boston Children's Hospital

Boston, Massachusetts, United States