Actively Recruiting
PRotein Optimization With eXercise to Improve MUscle Mass and Functional outcomeS
Led by Boston Children's Hospital · Updated on 2024-01-05
72
Participants Needed
2
Research Sites
175 weeks
Total Duration
On this page
Sponsors
B
Boston Children's Hospital
Lead Sponsor
J
Johns Hopkins University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
PRotein Optimization With eXercise to Improve MUscle Mass and Functional outcomeS
Who Can Participate
Eligibility Criteria
You may qualify if you...
- ICU patients aged 1 year to less than 18 years
- Require mechanical ventilation (endotracheal intubation, tracheostomy, or noninvasive ventilation) within the first 72 hours of PICU admission
- Able to consent to participate within 72 hours of starting mechanical ventilation
You will not qualify if you...
- Unable to receive enteral nutrition, parenteral nutrition, or on a specialized diet incompatible with the study intervention
- Fulminant liver failure
- Kidney failure at KDIGO Stage 3 or higher without replacement therapy
- Functional Status Scale score less than 9 at PICU admission
- End of life or redirection of care
- Receiving extracorporeal membrane oxygenation (ECMO) therapy
- Continuous neuromuscular blockade or medically/surgically required bedrest
- Participation in a conflicting interventional trial
- High risk of refeeding syndrome
- Inborn errors of metabolism
- High body surface area burns
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21218
Actively Recruiting
2
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
Research Team
N
Nilesh M. Mehta, MD
CONTACT
L
Lori Bechard, RD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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