PRotein Optimization With eXercise to Improve MUscle Mass and Functional outcomeS

Description

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.

Conditions

Muscle Loss, Protein, Mobility, Pediatric ALL

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Study Overview

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Study Details

Study overview

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.

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

PRotein Optimization With eXercise to Improve MUscle Mass and Functional outcomeS

Condition
Muscle Loss
Intervention / Treatment

-

Contacts and Locations

Baltimore

Johns Hopkins Hospital, Baltimore, Maryland, United States, 21218

Boston

Boston Children's Hospital, Boston, Massachusetts, United States, 02115

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

1 Year to 17 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Boston Children's Hospital,

Nilesh Mehta, MD, PRINCIPAL_INVESTIGATOR, Faculty, Boston Children's Hospital

Sapna R Kudchadkar, MD, PhD, PRINCIPAL_INVESTIGATOR, Faculty, Johns Hopkins

Study Record Dates

2026-06-30