Clinical trial Recruiting at 1 site Interventional Ages 6 Months to 12

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.

More Mechanical Ventilation Complication trials

Quick facts

Study typeInterventional
Ages6 Months to 12 Years
SexAll
Enrollment160 (estimated)
SponsorChildren's Hospital of Fudan University
Academic / other
Locations1 site (Shanghai)
StatusRecruiting
StartedApril 26, 2021
Main results expectedApril 2025
Study endsDecember 2025
Registry record updatedFebruary 12, 2025
Trial IDNCT04534296 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

  • Children's Hospital, Fudan University
    Shanghai, China
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.