Status:
RECRUITING
PRotein Optimization With eXercise to Improve MUscle Mass and Functional outcomeS
Lead Sponsor:
Boston Children's Hospital
Collaborating Sponsors:
Johns Hopkins University
Conditions:
Muscle Loss
Protein
Eligibility:
All Genders
1-17 years
Phase:
NA
Brief 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 comp...
Detailed Description
Mortality in U.S. pediatric intensive care units (PICUs) is improving, resulting in an increased focus on the quality of life of survivors who often have persistent physical, cognitive, and psychologi...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
February 20 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2026
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT05296096
Start Date
February 20 2023
End Date
June 30 2026
Last Update
January 5 2024
Active Locations (2)
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1
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21218
2
Boston Children's Hospital
Boston, Massachusetts, United States, 02115