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

Q: Is there a particular criterion that must be met to partake in this scientific endeavor?

This trial is enrolling 72 individuals between the age of one year and seventeen who possess certain proteins. In order to be considered for participation, prospective participants must demonstrate their capacity to consent within two days from when mechanical ventilation begins; they need to range in age from one (corrected) up until eighteen years old, require mechanical ventilation via intubation or tracheostomy during the initial 48 hours on a pediatric intensive care unit, with expected extubation period lasting at least another 48 hours.

Q: What is the desired outcome of this research project?

The primary goal of this 10-day trial is to measure the tolerance of a protein intervention, as indicated by changes in serum creatinine levels. Secondary objectives include evaluating motor and cognitive functions with standardized tests (PEDI-CAT), assessing physical, emotional and social health through quality of life questionnaires (PedsQoL) ,and measuring sensory, communication, motor, sensory and feeding abilities via Functional Status Scale testing.

Q: Does the demographic of this medical trial include individuals aged 55 and over?

This medical trial is seeking enrolment from individuals aged one year or above but under the age of 17.

Q: Are any new participants being accepted for this experiment?

Unfortunately, clinicaltrials.gov indicates that this trial is no longer seeking participants - the last update to its record was posted on August 5th 2022. Despite this, there are 48 other medical studies presently in need of volunteers.

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

PROXIMUS Trial 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.Check my eligibility

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.See study design

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.

PROXIMUS Trial 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.

PROXIMUS Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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

Change in Muscle mass thickness

Functional assessment - motor, cognitive and responsibility

+1 more

Other outcome measures

Protein catabolism (breakdown)

PROXIMUS 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 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Boston Children's HospitalLead Sponsor

761 Previous Clinical Trials

5,579,658 Total Patients Enrolled

Johns Hopkins UniversityOTHER

2,264 Previous Clinical Trials

14,823,105 Total Patients Enrolled

Nilesh Mehta, MDPrincipal InvestigatorFaculty, Boston Children's Hospital

Media Library

Protein dosage and rehabilitation team delivered exercise prescription Clinical Trial Eligibility Overview. Trial Name: NCT05296096 — N/A

Muscle Atrophy Research Study Groups: Standard protein and exercise, High protein plus exercise

Muscle Atrophy Clinical Trial 2023: Protein dosage and rehabilitation team delivered exercise prescription Highlights & Side Effects. Trial Name: NCT05296096 — N/A

Protein dosage and rehabilitation team delivered exercise prescription 2023 Treatment Timeline for Medical Study. Trial Name: NCT05296096 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there a particular criterion that must be met to partake in this scientific endeavor?

"This trial is enrolling 72 individuals between the age of one year and seventeen who possess certain proteins. In order to be considered for participation, prospective participants must demonstrate their capacity to consent within two days from when mechanical ventilation begins; they need to range in age from one (corrected) up until eighteen years old, require mechanical ventilation via intubation or tracheostomy during the initial 48 hours on a pediatric intensive care unit, with expected extubation period lasting at least another 48 hours."

Answered by AI

What is the desired outcome of this research project?

"The primary goal of this 10-day trial is to measure the tolerance of a protein intervention, as indicated by changes in serum creatinine levels. Secondary objectives include evaluating motor and cognitive functions with standardized tests (PEDI-CAT), assessing physical, emotional and social health through quality of life questionnaires (PedsQoL) ,and measuring sensory, communication, motor, sensory and feeding abilities via Functional Status Scale testing."

Answered by AI

Does the demographic of this medical trial include individuals aged 55 and over?

"This medical trial is seeking enrolment from individuals aged one year or above but under the age of 17."

Answered by AI

Are any new participants being accepted for this experiment?

"Unfortunately, clinicaltrials.gov indicates that this trial is no longer seeking participants - the last update to its record was posted on August 5th 2022. Despite this, there are 48 other medical studies presently in need of volunteers."

Answered by AI

Recent research and studies

Journal of Parenteral and Enteral NutritionJournal

Enteral Protein Supplementation in Critically Ill Children: A Randomized Controlled Pilot and Feasibility Study

Hauschild, Daniela B., Luna D. A. Oliveira, Mirelle S. Farias, Eliana Barbosa, Nilzete L. Bresolin, Nilesh M. Mehta, and Yara M. F. Moreno. 2018. “Enteral Protein Supplementation in Critically Ill Children: A Randomized Controlled Pilot and Feasibility Study”. Journal of Parenteral and Enteral Nutrition. Wiley. doi:10.1002/jpen.1416.

Journal of Pediatric Intensive CareJournal

Practice Recommendations for Early Mobilization in Critically Ill Children

Canci, Filomena, Heather Clark, Ramona Hopkins, Sapna Kudchadkar, Jamil Lati, Brenda Morrow, Charmaine Neu, Beth Wieczorek, Carleen Zebuhr, and Karen Choong. 2017. “Practice Recommendations for Early Mobilization in Critically Ill Children”. Journal of Pediatric Intensive Care. Georg Thieme Verlag KG. doi:10.1055/s-0037-1601424.

Pediatric Critical Care MedicineJournal

PICU Up!

Wieczorek, Beth, Judith Ascenzi, Yun Kim, Hallie Lenker, Caroline Potter, Nehal J. Shata, Lauren Mitchell, et al.. 2016. “PICU Up!”. Pediatric Critical Care Medicine. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/pcc.0000000000000983.

Critical Care MedicineJournal