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NCT05296096 · ClinicalTrials.gov registry record · NA
PRotein Optimization With eXercise to Improve MUscle Mass and Functional outcomeS
A NA study of Pediatric ALL and Muscle Loss, sponsored by Boston Children's Hospital.
- Recruiting
- Registry status
- NA
- Development phase
- 72
- Enrollment target
- 2
- Study locations
NCT05296096: Recruiting NA study of Pediatric ALL and Muscle Loss, sponsored by Boston Children's Hospital.
NCT05296096 is a NA study of Pediatric ALL and Muscle Loss that is actively recruiting participants, run by Boston Children's Hospital. The registered enrollment target is 72 participants, below the 1,645-participant average among 21 other Pediatric ALL trials with a reported enrollment target (96% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05296096, a NA study of Pediatric ALL and Muscle Loss, is actively recruiting participants, sponsored by Boston Children's Hospital.
- RECRUITING
- Registry status
- NA
- Development phase
- 72 participants
- Enrollment target
- 2
- Study locations
Study 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.
Primary Outcome
Feasibility (primary composite outcome) will be assessed by the following metrics: (1) \>80% of eligible patients are approached for consent; (2) \>35% of eligible patients are randomized (enrollment and consent); (3) \>80% of consented patients receive study treatments (allocation and adherence).
Conditions Studied
Interventions
- OTHER Protein dosage and rehabilitation team delivered exercise prescription
Study Locations (2)
Maryland
- Johns Hopkins Hospital - Baltimore
Massachusetts
- Boston Children's Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2023-02-20 |
| Est. Completion | 2026-06-30 |
| Phase | NA |
What NCT05296096 shows while recruiting
NCT05296096 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 72 participants, a relatively small participant target, below the 1,645-participant average among 21 other Pediatric ALL trials with a reported enrollment target (96% lower).
The record links to 4 conditions, with Pediatric ALL appearing as the primary indexed condition, and to 1 intervention - of which Protein dosage and rehabilitation team delivered exercise prescription is the first listed.
NCT05296096 reports a single indexed study location in Maryland, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT05296096 about?
NCT05296096 is a clinical study titled "PRotein Optimization With eXercise to Improve MUscle Mass and Functional outcomeS". 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 ph...
What is the current status of trial NCT05296096?
This trial is currently recruiting. It is a NA study. The enrollment target is 72 participants. The study started on 2023-02-20. Estimated completion is 2026-06-30.
What conditions does trial NCT05296096 study?
This clinical trial studies the following conditions: Pediatric ALL, Muscle Loss, Mobility, Protein.
What interventions are being tested in trial NCT05296096?
The interventions under investigation include: Protein dosage and rehabilitation team delivered exercise prescription (OTHER).
Who is sponsoring clinical trial NCT05296096?
This trial is sponsored by Boston Children's Hospital, which has 462 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05296096 being conducted?
This trial has 2 study locations across Maryland, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05296096's enrollment target sits among peer trials
72 11th of 21 higher than 11 of 21 other Pediatric ALL trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pediatric ALL trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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