An observational study in Physical Functional Impairment, Cognitive Impairment and Psychological Distress, sponsored by Children's Hospital of Fudan University. Not yet recruiting. Open to participants aged 29 Days to 18 Years. Per ClinicalTrials.gov, last updated 2026-10-15.
Sponsored by Children's Hospital of Fudan University · Observational
Children who survive critical illness may develop new or worsening problems with physical health, cognitive status, emotional well-being, and social functioning. These problems, collectively known as post-intensive care syndrome in pediatrics (PICS-p), may also affect family well-being. Evidence on how frequently these problems occur, how they change over time, and which factors influence recovery remains limited in China.
This single-center, prospective observational cohort study at Children's Hospital of Fudan University aims to describe the occurrence and recovery trajectories of PICS-p and identify factors associated with persistent difficulties or recovery. The study focuses on children admitted to the pediatric intensive care unit (PICU) with sepsis, severe pneumonia or acute respiratory distress syndrome, those receiving cranial neurosurgical care, and those requiring prolonged mechanical ventilation.
Clinical information and standardized assessments will be collected to evaluate physical function, overall quality of life, cognitive function, psychological well-being, social functioning, and family outcomes. Follow-up will include assessments at 1, 3, 6, and 12 months after PICU discharge, with longer-term follow-up planned at 2 years, 3 years, and beyond. The study will examine how outcomes change over time and identify potentially modifiable risk factors.
The findings will help identify early which children and families need additional support and guide the development of rehabilitation and coordinated follow-up care across hospital, home, and community settings.
3,930 studies on the registry are indexed under Cognitive Dysfunction; 1,114 are open to participants now.
This study's planned enrollment of 200 is above the median of 150 across 989 observational studies indexed under Cognitive Dysfunction.
Browse Cognitive Dysfunction studies →Children's Hospital of Fudan University is the lead sponsor of 266 studies on the registry; 95 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Children aged 28 days to 18 years admitted to the pediatric intensive care unit (PICU) at Children's Hospital of Fudan University in Shanghai, China, who stay in the PICU for more than 48 hours and survive the PICU stay. The cohort includes children with a range of critical illnesses, with particular focus on sepsis, severe pneumonia or acute respiratory distress syndrome, cranial neurosurgical conditions, and prolonged mechanical ventilation. Participants will be followed longitudinally to assess physical, cognitive, psychological, social, and family outcomes after discharge.
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Exclusion Criteria:
Health-Related Quality of Life Assessed by the PedsQL 4.0 Generic Core Scales Total Score
Time frame: 12 months after hospital discharge
Proportion of Children With Physical Functional Impairment
Time frame: 12 months after hospital discharge
Proportion of Children With Cognitive Impairment
Time frame: 12 months after hospital discharge
Proportion of Children With Psychological Impairment
Time frame: 12 months after hospital discharge
Proportion of Children With Social Functional Impairment
Time frame: 12 months after hospital discharge
Proportion of Families With Impaired Family Functioning
Time frame: 12 months after hospital discharge
Trajectory of Functional Status Scale (FSS) Scores During the First Year After Hospital Discharge
Time frame: 1, 3, 6, and 12 months after hospital discharge
Proportion of Children With Post-Traumatic Stress Symptoms
Time frame: 12 months after hospital discharge
Proportion of Children With Anxiety Symptoms
Time frame: 12 months after hospital discharge
Proportion of Children With Depressive Symptoms
Time frame: 12 months after hospital discharge
Family Functioning Assessed by the Family Assessment Device (FAD)
Time frame: 12 months after hospital discharge
Caregiver Psychological Well-Being
Time frame: 12 months after hospital discharge
Incidence of Intensive Care Unit-Acquired Weakness (ICU-AW)
Time frame: 12 months after hospital discharge
No study locations are listed for this record.
Plan to share: Undecided
Start is estimated for Sep 2026; primary completion for Mar 2029, 30 months later.
Of 515 non-industry observational studies under Cognitive Dysfunction, half reached primary completion within 51 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 124. This study's planned 30 months is below that.
Counting every sponsor, half of 551 studies reached it within 48 months; a quarter within 21 and three quarters within 118.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Children's Hospital of Fudan University →