RecruitingNot ApplicableNCT05296096

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


Sponsor

Boston Children's Hospital

Enrollment

72 participants

Start Date

Feb 20, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 1 YearMax Age: 17 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether an optimized protein and exercise program during a pediatric ICU stay can help children maintain muscle mass and recover better physical function after critical illness. **You may be eligible if...** - Your child is between 1 year (corrected age) and under 18 years old - Your child is admitted to a pediatric ICU (PICU) and requires a breathing machine (mechanical ventilation) within the first 72 hours of admission - Consent can be provided within 72 hours of starting mechanical ventilation **You may NOT be eligible if...** - Your child cannot receive tube feedings or nutrition through a vein (IV nutrition) - Your child has fulminant liver failure - Your child has severe kidney failure without dialysis - Your child is on ECMO (a heart-lung bypass machine) - Your child requires complete bed rest or continuous paralytic medications for medical or surgical reasons - Your child is at end-of-life or redirecting to comfort care Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

OTHERProtein 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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05296096


Related Trials