Impact of Early Mobilization on Diaphragm Thickness in Critically Ill Children
Official title: A Randomized Control Trial Comparing the Effects of Early Mobilization and Routine Care on Diaphragmatic Thickness
Run by Children's Hospital of Fudan University · NCT04534296 · Data updated 2026-11-12
This study is testing if getting critically ill children moving early while they are on a ventilator can help keep their diaphragm stronger compared to just regular care.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 6 Months to 12 Years |
| Sex | All |
| Enrollment | 160 (estimated) |
| Sponsor | Children's Hospital of Fudan University Academic / other |
| Locations | 1 site (Shanghai) |
| Status | Recruiting |
| Started | April 26, 2021 |
| Main results expected | April 2025 |
| Study ends | December 2025 |
| Registry record updated | February 12, 2025 |
| Trial ID | NCT04534296 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are children aged 6 months to 12 years who have been intubated and mechanically ventilated for less than 24 hours.
✕Probably not a fit
Patients with a history of diaphragmatic paralysis, neuromuscular disease, or those expected to be liberated from the ventilator in less than 24 hours may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to compare the effects of early mobilization versus routine care on diaphragm thickness in critically ill children who are mechanically ventilated. Mechanical ventilation can lead to diaphragm weakness, known as ventilator-induced diaphragm dysfunction (VIDD), which can be assessed using bedside ultrasonography. The researchers hypothesize that early mobilization will reduce the incidence of diaphragm atrophy compared to standard care. By conducting a randomized trial, they will evaluate changes in diaphragm thickness over time in the participating children.
Why it matters
Potential benefit: If successful, this approach could improve diaphragm function and recovery in critically ill children on mechanical ventilation.
How similar studies have gone: While the approach of early mobilization is gaining attention, the specific impact on diaphragm thickness in this population is still being explored and may be novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * subjects \> 6 months and \< 12 years of age; * subjects been intubated and mechanically ventilated for \< 24 hours at the time of screening; * the Glasgow Coma Scale (GCS) on admission of Pediatric Intensive Care Unit (PICU) is greater than 3 Exclusion Criteria: * cardiopulmonary arrest; * history of diaphragmatic paralysis or neuromuscular disease; * neuromuscular blockade; * expectation to be liberated from ventilator in \< 24 hours * history of mechanical ventilation in the last 6 months * presence of tracheostomy * high cervical spine injury * status convulsion * thoracic trauma when ultrasonic examination cannot be performed
Where it's running
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Children's Hospital, Fudan University
Shanghai, China Recruiting
Study contacts
- Study coordinator: Sujuan Wang
- Email: sujuanw@163.com
- Phone: 86-13761000512
Similar studies
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.