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High Protein Diet + Exercise for Muscle Loss (PROXIMUS Trial)

Boston, MA

N/A

Recruiting

Led By Nilesh Mehta, MD

Research Sponsored by Boston Children's Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

PICU patients aged 1 year (corrected) to <18 years

Require mechanical ventilation (endotracheal intubation or tracheostomy) in the first 48 hours of PICU admission, and are expected to remain intubated for ≥48 hours

Must not have

Kidney failure (≥KDIGO Stage 3) without replacement therapy

Inborn errors of metabolism

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether a high protein diet and individualized exercise plan can help preserve muscle mass and improve function in children during the acute phase of critical illness.

Who is the study for?

This trial is for children aged 1 to under 18 years who are on mechanical ventilation within the first 48 hours of PICU admission and expected to stay on it. They must be able to consent within this period. It's not for those with liver failure, certain medical conditions requiring bedrest, high-risk burns, severe kidney issues without therapy, or incompatible diets.

What is being tested?

The PROXIMUS study tests if giving high protein with tailored exercise during critical illness helps maintain muscle mass and improve mobility in kids after treatment. Participants will either receive this new approach or standard care, decided randomly at two centers.

What are the potential side effects?

Potential side effects may include digestive discomfort due to high protein intake and physical strain from exercise routines. However, the main focus is on feasibility and safety so close monitoring will occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 1 and 17 years old, corrected for prematurity.

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I needed a breathing tube within the first 48 hours of ICU admission and will need it for at least 2 more days.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My kidney function is severely reduced and I am not on dialysis.

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I have a genetic disorder that affects my metabolism.

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I have severe burns covering a large part of my body.

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I am receiving or have received ECMO therapy.

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I am experiencing severe liver failure.

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I need to be in bed or have muscle relaxants for medical reasons.

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My child was fairly active when admitted to the PICU.

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I cannot receive standard nutrition support or follow the study's diet.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Feasibility of recruitment and adherence to study procedures

Safety of protein (new renal injury) and exercise interventions (any associated adverse events)

Tolerability of protein intervention (serum creatinine change)

Secondary study objectives

Assessment of Functional status - sensory, communication, motor, sensory and feeding

Change in Muscle mass thickness

Functional assessment - motor, cognitive and responsibility

+1 more

Other study objectives

Protein catabolism (breakdown)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: High protein plus exerciseExperimental Treatment1 Intervention

High protein nutrition: To achieve the prescribed age-appropriate high protein target, dietitians will use EN preferentially, or if EN is contraindicated, PN may be used. High-protein EN formulas and/or protein supplements (powder or liquid) will be added to formula/breast milk feedings or administered separately in divided bolus doses. Dietitians routinely employ and customize these solutions in their scope of practice. When EN is insufficient to meet protein targets, PN may be prescribed to make up the deficit on or after the end of PICU day 3. Energy and protein delivery adequacy (% of prescribed goal) will be monitored daily by the study team. Patients in this arm will also be prescribed the age-appropriate highest-level of mobility by the rehabilitation team with a goal of 30 minutes duration, twice daily.

Group II: Standard protein and exerciseActive Control1 Intervention

All enrolled patients randomized to this arm will receive a baseline nutrition and nurse-driven mobility pathway and other evidence-based bundled strategies as standard of care.

0 / 10Eligibility criteria met