Pediatric Delirium in Swedish Paediatric Intensive Care Units

NCT07365215 | Completed

• 1 other identifier: 2023-01737-01
• Study Type: observational
• Target: 676
• Locations: 1 country
• Sites: 3

Brief Summary

This observational study aims to determine the incidence of delirium among children in a pediatric intensive care unit (PICU) and to identify associated risk factors. Research Questions: What is the incidence of delirium among children in a pediatric intensive care unit? What are the identifiable risk factors that predispose children in a pediatric intensive care unit to developing delirium?

Conditions

Pediatric Intensive Care; Risk Factors; Pediatric Delirium

Keywords

Pediatric Delirium; Delirium Assessment; PICU; Pediatric intensive care unit; Incidence; Risk Factors; CAPD; Cornell Assessment of Pediatric Delirium; Critical Care; Children; Sweden

Outcome Measures

Primary Outcomes (1)

• Incidence of Delirium

  This measure reports the proportion of participants who experience at least one episode of delirium during their pediatric intensive care unit (PICU) stay. Delirium is defined as an acute change in mental status characterized by impaired attention, disorganized thinking, or altered consciousness. Delirium will be determined by daily, once-per-shift assessments using the Cornell Assessment of Pediatric Delirium (CAPD) instrument, a validated bedside screening tool administered by trained nurses. A CAPD score of 9 or higher (on a scale of 0-32, with higher scores indicating greater delirium severity) will be considered indicative of delirium.

  Up to 24 months from PICU admission.

Secondary Outcomes (3)

• Identification of Risk Factors for Delirium

  Up to 24 months from PICU admission.

• Cumulative Duration of Delirium

  Up to 24 months from PICU admission.

• Delirium Subtype Characterization (Hypoactive, Hyperactive, Mixed)

  Up to 24 months from PICU admission.

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

All children admitted to a pediatric intensive care unit with an expected time of care for at least one over night stay

You may qualify if:

• Expected time of care at the pediatric intensive care unit for at least one overnight stay

You may not qualify if:

• Care at the very end of life

Sponsors & Collaborators

• Uppsala University: lead
• Vastra Gotaland Region: collaborator
• Region Skane: collaborator
• Uppsala University Hospital: collaborator

Study Sites (3)

BIVA Göteborg

Gothenburg, Sweden

Location

BIVA Lund

Lund, Sweden

Location

BIVA Uppsala

Uppsala, Sweden

Location

Related Publications (14)

• Thibault C, Pont-Thibodeau GD, MacDonald S, Jutras C, Metras ME, Harrington K, Toledano B, Roumeliotis N, Farrell C, Lacroix J, Ducharme-Crevier L. Two months outcomes following delirium in the pediatric intensive care unit. Eur J Pediatr. 2024 Jun;183(6):2693-2702. doi: 10.1007/s00431-024-05491-w. Epub 2024 Mar 23.

  PMID: 38520519 BACKGROUND

• Dervan LA, Killien EY, Smith MB, Watson RS. Health-Related Quality of Life Following Delirium in the PICU. Pediatr Crit Care Med. 2022 Feb 1;23(2):118-128. doi: 10.1097/PCC.0000000000002813.

  PMID: 34534165 BACKGROUND

• Ge XH, Wei WR, Feng TN, Xu LL, Hu YQ, Yuan CR. Analysis of risk factor for pediatric intensive care unit delirium in children: a case-control study. Am J Transl Res. 2021 Aug 15;13(8):9143-9151. eCollection 2021.

  PMID: 34540029 BACKGROUND

• Semple D, Howlett MM, Strawbridge JD, Breatnach CV, Hayden JC. A Systematic Review and Pooled Prevalence of Delirium in Critically Ill Children. Crit Care Med. 2022 Feb 1;50(2):317-328. doi: 10.1097/CCM.0000000000005260.

  PMID: 34387241 BACKGROUND

• Harris J, Ramelet AS, van Dijk M, Pokorna P, Wielenga J, Tume L, Tibboel D, Ista E. Clinical recommendations for pain, sedation, withdrawal and delirium assessment in critically ill infants and children: an ESPNIC position statement for healthcare professionals. Intensive Care Med. 2016 Jun;42(6):972-86. doi: 10.1007/s00134-016-4344-1. Epub 2016 Apr 15.

  PMID: 27084344 BACKGROUND

• Pilato TC, Mauer EA, Gerber LM, Traube C. Pediatric Delirium and All-Cause PICU Readmissions Within 1 Year. Pediatr Crit Care Med. 2022 Oct 1;23(10):766-773. doi: 10.1097/PCC.0000000000003037. Epub 2022 Jul 27.

  PMID: 35894610 BACKGROUND

• Siegel EJ, Traube C. Pediatric delirium: epidemiology and outcomes. Curr Opin Pediatr. 2020 Dec;32(6):743-749. doi: 10.1097/MOP.0000000000000960.

  PMID: 33105274 BACKGROUND

• Smith HAB, Besunder JB, Betters KA, Johnson PN, Srinivasan V, Stormorken A, Farrington E, Golianu B, Godshall AJ, Acinelli L, Almgren C, Bailey CH, Boyd JM, Cisco MJ, Damian M, deAlmeida ML, Fehr J, Fenton KE, Gilliland F, Grant MJC, Howell J, Ruggles CA, Simone S, Su F, Sullivan JE, Tegtmeyer K, Traube C, Williams S, Berkenbosch JW. 2022 Society of Critical Care Medicine Clinical Practice Guidelines on Prevention and Management of Pain, Agitation, Neuromuscular Blockade, and Delirium in Critically Ill Pediatric Patients With Consideration of the ICU Environment and Early Mobility. Pediatr Crit Care Med. 2022 Feb 1;23(2):e74-e110. doi: 10.1097/PCC.0000000000002873.

  PMID: 35119438 BACKGROUND

• Traube C, Silver G, Kearney J, Patel A, Atkinson TM, Yoon MJ, Halpert S, Augenstein J, Sickles LE, Li C, Greenwald B. Cornell Assessment of Pediatric Delirium: a valid, rapid, observational tool for screening delirium in the PICU*. Crit Care Med. 2014 Mar;42(3):656-63. doi: 10.1097/CCM.0b013e3182a66b76.

  PMID: 24145848 BACKGROUND

• Xu TT, Zhang YC, Ye XF, Fu CH, Li Y, Ju MJ, Liu J, Yang XY, Zhang WY. Risk factors of delirium in a paediatric intensive care unit: A prospective case series study. Nurs Crit Care. 2023 Sep;28(5):645-652. doi: 10.1111/nicc.12920. Epub 2023 Apr 26.

  PMID: 37186353 BACKGROUND

• Traube C, Mauer EA, Gerber LM, Kaur S, Joyce C, Kerson A, Carlo C, Notterman D, Worgall S, Silver G, Greenwald BM. Cost Associated With Pediatric Delirium in the ICU. Crit Care Med. 2016 Dec;44(12):e1175-e1179. doi: 10.1097/CCM.0000000000002004.

  PMID: 27518377 BACKGROUND

• Lei L, Li Y, Xu H, Zhang Q, Wu J, Zhao S, Zhang X, Xu M, Zhang S. Incidence, associated factors, and outcomes of delirium in critically ill children in china: a prospective cohort study. BMC Psychiatry. 2023 Dec 11;23(1):925. doi: 10.1186/s12888-023-05406-3.

  PMID: 38082396 BACKGROUND

• Dervan LA, Di Gennaro JL, Farris RWD, Watson RS. Delirium in a Tertiary PICU: Risk Factors and Outcomes. Pediatr Crit Care Med. 2020 Jan;21(1):21-32. doi: 10.1097/PCC.0000000000002126.

  PMID: 31568239 BACKGROUND

• Khan S, Haseeb A, Khalid M, Sher A, Haque A. Frequency and risk factors of delirium in the pediatric intensive care unit of a tertiary care hospital: A prospective observational study. Journal of pediatric critical care. 2024;11(1):10-4.

  BACKGROUND

Study Officials

• Ylva Therström Blomqvist, Assoc Prof

  Uppsala University, Department of Women's and Children's Health

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: January 26, 2026
• Study Start: December 1, 2023
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: January 26, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available beginning 12 months after publication of the primary results and will remain available upon reasonable request for at least 5 years thereafter.
• Access Criteria: Access to the de-identified dataset will be granted to qualified researchers upon reasonable request. Requests must include a brief description of the research question, analysis plan, and intended use of the data. All requests will be reviewed by the PADI steering committee. Data will be shared only for scientifically sound projects and for purposes consistent with the original study objectives and ethical approvals. Data will be shared through secure data transfer following approval of a data sharing agreement. No direct identifiers or site-specific identifiers will be included in the shared dataset.

Locations

SE (3)