PICS-p Longitudinal Cohort Study

NCT07876271 | Not Yet Recruiting

• 1 other identifier: No.(2026)345
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Physical Functional Impairment; Cognitive Impairment; Psychological Distress; Impaired Social Functioning

Keywords

Pediatric Post-Intensive Care Syndrome; PICS-p; Pediatric Intensive Care Unit; Critical Illness Survivorship; Prospective Cohort Study; Long-Term Outcomes

Outcome Measures

Primary Outcomes (6)

• Health-Related Quality of Life Assessed by the PedsQL 4.0 Generic Core Scales Total Score

  12 months after hospital discharge

• Proportion of Children With Physical Functional Impairment

  12 months after hospital discharge

• Proportion of Children With Cognitive Impairment

  12 months after hospital discharge

• Proportion of Children With Psychological Impairment

  12 months after hospital discharge

• Proportion of Children With Social Functional Impairment

  12 months after hospital discharge

• Proportion of Families With Impaired Family Functioning

  12 months after hospital discharge

Secondary Outcomes (7)

• Trajectory of Functional Status Scale (FSS) Scores During the First Year After Hospital Discharge

  1, 3, 6, and 12 months after hospital discharge

• Proportion of Children With Post-Traumatic Stress Symptoms

  12 months after hospital discharge

• Proportion of Children With Anxiety Symptoms

  12 months after hospital discharge

• Proportion of Children With Depressive Symptoms

  12 months after hospital discharge

• Family Functioning Assessed by the Family Assessment Device (FAD)

  12 months after hospital discharge

Study Arms (1)

Pediatric Intensive Care Survivors

Eligibility Criteria

• Age: 29 Days - 18 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• Age from 28 days after birth through 18 years.
• Pediatric intensive care unit (PICU) length of stay exceeding 48 hours.

You may not qualify if:

• PICU admission for transitional postoperative care following general abdominal surgery, except liver transplantation.
• Death during the PICU stay.
• Expected death within 24 hours after hospital discharge in the context of brain death or a decision to forgo further life-sustaining treatment.
• Inability to complete baseline cognitive or functional assessments with sufficient reliability to support study evaluation and follow-up.

Sponsors & Collaborators

• Children's Hospital of Fudan University: lead

Related Publications (10)

• Engel J, von Borell F, Baumgartner I, Kumpf M, Hofbeck M, Michel J, Neunhoeffer F. Modified ABCDEF-Bundles for Critically Ill Pediatric Patients - What Could They Look Like? Front Pediatr. 2022 May 2;10:886334. doi: 10.3389/fped.2022.886334. eCollection 2022.

  PMID: 35586826 BACKGROUND

• Renner C, Jeitziner MM, Albert M, Brinkmann S, Diserens K, Dzialowski I, Heidler MD, Luck M, Nusser-Muller-Busch R, Sandor PS, Schafer A, Scheffler B, Wallesch C, Zimmermann G, Nydahl P. Guideline on multimodal rehabilitation for patients with post-intensive care syndrome. Crit Care. 2023 Jul 31;27(1):301. doi: 10.1186/s13054-023-04569-5.

  PMID: 37525219 BACKGROUND

• Al-Harbi S. Early Mobilization in Pediatric Critical Care: Exploring the Gap Between Theory and Practice in Saudi Arabia. Med Sci Monit. 2024 Mar 2;30:e942467. doi: 10.12659/MSM.942467.

  PMID: 38429924 BACKGROUND

• Garcia-Fernandez J, Romero-Garcia M, Benito-Aracil L, Pilar Delgado-Hito M. Humanisation in paediatric intensive care units: A narrative review. Intensive Crit Care Nurs. 2024 Dec;85:103725. doi: 10.1016/j.iccn.2024.103725. Epub 2024 May 31.

  PMID: 38824005 BACKGROUND

• Micaelli D, Naudin J, Dauger S, Levy M, Kerever S. Patient follow-up after discharge from the paediatric intensive care unit: A scoping review. Nurs Crit Care. 2025 May;30(3):e13187. doi: 10.1111/nicc.13187. Epub 2024 Oct 18.

  PMID: 39421878 BACKGROUND

• Quadir A, Festa M, Gilchrist M, Thompson K, Pride N, Basu S. Long-term follow-up in pediatric intensive care-a narrative review. Front Pediatr. 2024 Jul 1;12:1430581. doi: 10.3389/fped.2024.1430581. eCollection 2024.

  PMID: 39011062 BACKGROUND

• He X, Song Y, Cao Y, Miao L, Zhu B. Post intensive care syndrome: A review of clinical symptoms, evaluation, intervention. Heliyon. 2024 May 17;10(10):e31278. doi: 10.1016/j.heliyon.2024.e31278. eCollection 2024 May 30.

  PMID: 38803859 BACKGROUND

• Ong C, Lee JH, Leow MK, Puthucheary ZA. Functional Outcomes and Physical Impairments in Pediatric Critical Care Survivors: A Scoping Review. Pediatr Crit Care Med. 2016 May;17(5):e247-59. doi: 10.1097/PCC.0000000000000706.

  PMID: 27030932 BACKGROUND

• Tang B, Chen WJ, Jiang LD, Zhu SH, Song B, Chao YG, Song TJ, He W, Liu Y, Zhang HM, Chai WZ, Yin MG, Zhu R, Liu LX, Wu J, Ding X, Shang XL, Duan J, Xu QH, Zhang H, Wang XM, Huang QB, Gong RC, Li ZZ, Lu MS, Wang XT. [Expert consensus on late stage of critical care management]. Zhonghua Nei Ke Za Zhi. 2023 May 1;62(5):480-493. doi: 10.3760/cma.j.cn112138-20221005-00731. Chinese.

  PMID: 37096274 BACKGROUND

• Manning JC, Pinto NP, Rennick JE, Colville G, Curley MAQ. Conceptualizing Post Intensive Care Syndrome in Children-The PICS-p Framework. Pediatr Crit Care Med. 2018 Apr;19(4):298-300. doi: 10.1097/PCC.0000000000001476.

  PMID: 29406379 BACKGROUND

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Zhengzheng Zhang, MD

CONTACT

86 18121445817; 6710916@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2026
• First Posted: October 15, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: October 15, 2026

Record last verified: 2026-10