Combining high protein intake with exercise to improve muscle mass and function in critically ill children
PRotein Optimization With eXercise to Improve MUscle Mass and Functional outcomeS - a Pilot Feasibility, Randomized Controlled Trial
This study is testing if giving high protein nutrition and personalized exercise to critically ill children on ventilators can help them keep their muscle mass and improve their function compared to standard care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 72 (estimated) |
| Ages | 1 Year to 17 Years |
| Sex | All |
| Sponsor | Boston Children's Hospital Academic / other |
| Locations | 2 sites (Baltimore, Maryland and 1 other locations) |
| Trial ID | NCT05296096 on ClinicalTrials.gov |
What this trial studies
This pilot feasibility trial aims to evaluate the safety and effectiveness of a combined intervention of high protein nutrition and individualized exercise for mechanically ventilated children in pediatric intensive care units. The study will compare this intervention against standard management to assess its impact on muscle mass preservation and functional outcomes at one and six months post-randomization. Conducted at two centers, the trial will involve a randomized controlled design to gather preliminary data that could inform larger studies in the future.
Who should consider this trial
Good fit: Ideal candidates include children aged 1 to 17 years who require mechanical ventilation within the first 72 hours of PICU admission.
Not a fit: Patients with severe liver or kidney failure, those on incompatible diets, or with certain critical conditions may not benefit from this intervention.
Why it matters
Potential benefit: If successful, this approach could significantly improve muscle mass and functional recovery in critically ill pediatric patients.
How similar studies have performed: While this specific approach is novel in pediatric populations, previous studies in adults have shown promising results with similar interventions combining nutrition and early mobility.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion 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. 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.
Where this trial is running
Baltimore, Maryland and 1 other locations
- Johns Hopkins Hospital — Baltimore, Maryland, United States (Recruiting)
- Boston Children's Hospital — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Nilesh Mehta, MD — Faculty, Boston Children's Hospital
- Study coordinator: Nilesh M. Mehta, MD
- Email: nilesh.mehta@childrens.harvard.edu
- Phone: 6173557327
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.