Prospective Prevalence and Validation Study of Pediatric Intensive Care Delirium.

NCT04774211 | Completed DMC

• 1 other identifier: NNF20OC0066074
• Study Type: observational
• Target: 141
• Locations: 1 country
• Sites: 1

Brief Summary

Pediatric delirium (PD) is a poorly investigated clinical problem that needs to be further explored in a Danish context. Children are at risk of discomfort and suffering if they experience delirium. The condition is associated with prolonged mechanical ventilation, longer hospital stay, increased mortality, and risk of long-term cognitive impairment. Therefore, it is important to assess critically ill children with a validated tool to enable early detection and management of the condition. In this study, the investigators will determine the prevalence of pediatric intensive care delirium. To this end, the investigators will validate the Sophia Observation withdrawal Symptoms - Pediatric delirium scale (SOS-PD) for patient assessment.

Conditions

Pediatric Delirium

Outcome Measures

Primary Outcomes (1)

• Prevalence of delirium in children aged 3 months -18 years of age

  Delirium prevalence is determined by the proportion of patients that had at least one positive delirium score with patients that never had a positive delirium score determined by Sophia Observation Withdrawal Symptoms - Pediatric Delirium scale (SOS-PD). The minimum score of SOS-PD is 0 and maximum score is 17. The score ≥4 indicates delirium.

  The observation period is 24 hours

Secondary Outcomes (1)

• Validation of the Sophia Observation Withdrawal Symptoms - Pediatric Delirium scale (SOS-PD) assessment tool in to a Danish context.

  The observation period is 24 hours

Interventions

SOS-PD DIAGNOSTIC_TEST

Validation of SOS-PD bedside assessments comparing the Danish SOS-PD scale with a Child Psychiatrist using DSM-V as the reference standard

Eligibility Criteria

• Age: 3 Months - 18 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Pediatric intensive care patients

You may qualify if:

• Pediatric intensive care patients
• Length of stay of 48 hours or more

You may not qualify if:

• Non Danish speaking
• Use of neuromuscular blocking agents
• sedation level at COMFORT behavior score \> 11 or Richmond Agitation Sedation Scale \> -3

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• Novo Nordisk A/S: collaborator

Study Sites (1)

Rigshospitalet

Copenhagen, 2100, Denmark

Location

Study Officials

• Suzanne Forsyth Herling

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: February 22, 2021
• First Posted: March 1, 2021
• Study Start: January 1, 2021
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: August 31, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)