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Physical Functional ImpairmentPICSpLCSNCT07876271

PICS-p Longitudinal Cohort Study

An observational study of Physical Functional Impairment and Cognitive Impairment, run by Children's Hospital of Fudan University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 29 days to 18 years
How many people
200 participants
Where
No sites listed yet
Study dates
Sep 2026to Dec 2029
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 29 days to 18 years
  • All sexes
  • Child, Adult

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.

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Zhengzheng Zhang, MD contact

86 18121445817

6710916@163.com

About this study

Official title: Post-Intensive Care Syndrome - Pediatrics (PICS-p) Longitudinal Cohort Study

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.

Read more

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.

Keywords
Pediatric Post-Intensive Care Syndrome, PICS-p, Pediatric Intensive Care Unit, Critical Illness Survivorship, Prospective Cohort Study, Long-Term Outcomes
Medical subject headings
Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07876271
Study groupRoleWhat they receive
Pediatric Intensive Care SurvivorsNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 12 months after hospital discharge

  2. Proportion of Children With Physical Functional Impairment

    Measured: 12 months after hospital discharge

  3. Proportion of Children With Cognitive Impairment

    Measured: 12 months after hospital discharge

  4. Proportion of Children With Psychological Impairment

    Measured: 12 months after hospital discharge

  5. Proportion of Children With Social Functional Impairment

    Measured: 12 months after hospital discharge

  6. Proportion of Families With Impaired Family Functioning

    Measured: 12 months after hospital discharge

Secondary outcomes (7)

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

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

  2. Proportion of Children With Post-Traumatic Stress Symptoms

    Measured: 12 months after hospital discharge

  3. Proportion of Children With Anxiety Symptoms

    Measured: 12 months after hospital discharge

  4. Proportion of Children With Depressive Symptoms

    Measured: 12 months after hospital discharge

  5. Family Functioning Assessed by the Family Assessment Device (FAD)

    Measured: 12 months after hospital discharge

  6. Caregiver Psychological Well-Being

    Measured: 12 months after hospital discharge

  7. Incidence of Intensive Care Unit-Acquired Weakness (ICU-AW)

    Measured: 12 months after hospital discharge

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Oct 2026
  2. Study startSep 2026 (estimated)
  3. Primary completionMar 2029 (estimated)
  4. Study completionDec 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07876271
Sponsor's protocol ID
No.(2026)345
Acronym
PICSpLCS
Status last verified
Oct 2026
First submitted
9 Oct 2026
Last updated
15 Oct 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 35586826

  • 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.

    PubMed 37525219

  • 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.

    PubMed 38429924

  • 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.

    PubMed 38824005

  • 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.

    PubMed 39421878

  • 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.

    PubMed 39011062

  • 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.

    PubMed 38803859

  • 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.

    PubMed 27030932

  • 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.

    PubMed 37096274

  • 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.

    PubMed 29406379

Questions about this trial

What is this clinical trial studying?

An observational study of Physical Functional Impairment and Cognitive Impairment, run by Children's Hospital of Fudan University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Zhengzheng Zhang, MD (86 18121445817, 6710916@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Health-Related Quality of Life Assessed by the PedsQL 4.0 Generic Core Scales Total Score (time frame: 12 months after hospital discharge). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07876271, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.

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