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Protein and exercise combo tested to fight muscle loss in sick kids

NCT ID NCT05296096

Disease control Sponsor: Boston Children's Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This pilot study tested whether giving critically ill children on breathing machines extra protein along with a personalized exercise program could help preserve muscle mass and improve recovery. The trial enrolled 18 children in the ICU and measured how feasible and safe the approach was. The goal is to use these results to design a larger study that could lead to better outcomes for young patients.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
high protein diet and individualized exercise program
What this could lead to
If this approach works, it could help prevent muscle loss and improve recovery in children who are critically ill and on breathing machines.
What could go wrong
This is a very small pilot study with only 18 participants, so results may not apply to all children. The high protein diet may cause kidney strain or digestive issues.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

18 people

The number who actually took part.

Started

Feb 2023

Finished

Jan 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

1 year to 17 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

childhood acute lymphoblastic leukemia Motor Activity muscular atrophy Precursor Cell Lymphoblastic Leukemia-Lymphoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Mobility Muscle loss Pediatric ALL Protein

Contacts and locations

Locations

  • Boston Children's Hospital

    Boston, Massachusetts, 02115, United States

  • Johns Hopkins Hospital

    Baltimore, Maryland, 21218, United States

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