Current Environment:

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 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

Recruitment Status

Not yet recruiting

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 psychological impairments. Mechanically ventilated children in particular experience immobilization and poor nutrient intake, which results in muscle loss during acute illness. Early mobility and optimal nutrition during acute critical illness have been associated with muscle mass preservation and decreased duration of mechanical ventilation. These interventions may have the potential to decrease preventable PICU-acquired morbidities. However, the optimal doses and long-term benefits of these interventions have not been shown in randomized studies of critically ill PICU patients. Thus, the investigators will test the first pediatric-specific, inter-professional intervention that integrates high protein and individualized exercise. This intervention was developed by a team of experts in the fields of nutrition, early mobility, rehabilitative exercise, muscle ultrasound (US), and functional outcomes. The investigators propose a 2-center, pilot feasibility, randomized controlled trial (PROXIMUS) with the following Specific Aims: To determine the feasibility and safety of a randomized open-label trial comparing high protein combined with individualized exercise vs. standard management during the acute phase of critical illness in children; To determine the impact of high protein and individualized exercise on preservation of muscle mass; and To determine the impact of high protein and individualized exercise on functional status at 1 month and 6 months after randomization. Outcomes: The investigators will assess feasibility with a composite measure that combines predetermined thresholds for screening, enrollment, allocation, and compliance/adherence with significant separation in doses of protein and exercise between the two arms. Safety will be defined as absence of difference in rates of new renal injury and exercise related adverse events. Preservation of muscle mass will be assessed by percent daily change in US-measured quadriceps femoris muscle thickness (QFMT) during the PICU stay. The investigators will use a validated imaging protocol with high reliability and reproducibility. The investigators will also examine the difference in the normative standard scores (T-scores) between the two arms for the Pediatric Evaluation of Disability Inventory - Computer Adaptive Test (PEDI-CAT) assessment. Other secondary outcomes are Functional Status Scale, PedsQL, and muscle quality by US. The investigators hypothesize that a larger trial will be feasible and safe. Patients randomized to the combined intervention will have lower decline in QFMT and better scores on PEDI-CAT assessment. If proven feasible and safe, the PROXIMUS intervention has potential to profoundly change medical care in the PICU and substantially impact public health by improving long-term outcomes for the growing number of pediatric survivors of critical illness.

Eligibility Criteria

Inclusion Criteria:

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
Able to consent to participate within 48 hours of initiation of mechanical ventilation initiation.

Exclusion Criteria:

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.

Intervention

Intervention Type

Intervention Name

Other

Protein dosage and rehabilitation team delivered exercise prescription

Phase

Not Applicable

Gender

All

Min Age

1 Year

Max Age

17 Years

Download Date

August 9, 2022

Principal Investigator

Nilesh Mehta

This field has been modified from ClinicalTrials.gov to show a contact specific to Boston Children's.

Primary Contact Information

Lori Bechard, RD, PhD
lori.bechard@childrens.harvard.edu
617-355-7327

This field has been modified from ClinicalTrials.gov to show a contact specific to Boston Children's.

For more information on this trial, visit clinicaltrials.gov.

Contact

For more information and to contact the study team: