By InvitationNot Applicable

Development of an Early Warning Model for Intensive Care Unit-Acquired Weakness in Mechanically Ventilated Children

China1,500 participantsStarted 2026-03-01

Plain-language summary

Acquired weakness (AW) is a common complication among patients in the Intensive Care Unit (ICU). It is a systemic muscle weakness and dysfunction associated with critical illness, often related to prolonged bed rest, mechanical ventilation, systemic inflammatory response syndrome (SIRS), and multiple organ dysfunction syndrome (MODS). The primary clinical manifestations include weakness in limb and respiratory muscles, particularly diminished strength in distal muscle groups. As a result, the weaning process from mechanical ventilation becomes more challenging, leading to prolonged ICU stays, increased mortality, and a higher risk of long-term functional disability. The significance of AW lies not only in its substantial impediment to short-term recovery but also in its role as a core component of Post-Intensive Care Syndrome (PICS), profoundly affecting patients' long-term outcomes. Mechanical ventilation is a vital life-support technology for critically ill children in the Pediatric Intensive Care Unit (PICU). However, complications associated with mechanical ventilation have garnered increasing attention, particularly Acquired Weakness in mechanically ventilated children. With improving survival rates in the PICU, a growing number of pediatric critical illness survivors are at risk of developing AW. Despite rapid advancements in pediatric critical care medicine in China, there is currently a lack of an early warning system for AW in children receiving mechanical ventilation, resulting in significantly delayed clinical interventions. This project aims to identify novel biomarkers for pediatric ICU-AW and develop an early warning model. It holds promise for transitioning from the traditional post-symptomatic diagnostic approach to subclinical prediction of AW in children, which is of great clinical value for reducing disability rates and optimizing critical care rehabilitation strategies.

Who can participate

Age range

1 Month – 18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Age between 28 days and 18 years;
. Patients continuously admitted to the PICU during the study period and subjected to invasive mechanical ventilation.

Exclusion criteria

. Mechanical ventilation duration \< 72 hours;
. Presence of primary central or neuromuscular diseases that significantly affect central or peripheral respiratory failure, including: traumatic brain injury, cerebrovascular disease history (e.g., cerebral hemorrhage, cerebral infarction), intracranial tumors, central nervous system infections, spinal cord injury, Guillain-Barré syndrome, porphyria, paraneoplastic neuropathy, etc.;
. Conditions requiring immobilization such as limb joint surgery or fractures.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Since this study is about building an early warning model for ICU-acquired weakness in children on mechanical ventilation, can you explain what ICU-acquired weakness actually is and whether my child is at risk of developing it during their ICU stay?
2This trial is measuring how often ICU-acquired weakness occurs in mechanically ventilated children — does that mean my child's data might be collected and used to help build this prediction model, and what would that actually involve for us?
3Since this study is 'enrolling by invitation only,' what would it mean if my child were invited to participate — would it change any part of their care or treatment in any way?
4Because this appears to be an observational study focused on developing a predictive model rather than testing a treatment, are there any direct benefits or risks to my child from being part of it, or is it primarily contributing to future research?
5If this early warning model is still being developed, what tools or warning signs are doctors currently using to monitor my child for muscle weakness during their time on the ventilator?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The occurrence rate of ICU-AW

Timeframe: Diagnosis of ICU-AW in mechanically ventilated children was determined based on assessments at day 10.

Trial details

NCT IDNCT07150637

SponsorChildren's Hospital of Fudan University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-12-31

View on ClinicalTrials.gov More ICU Acquired Weakness trials